10a Aepcc Guidelines Colpos

ISBN 978-84-09-06631-5
COLPOSCOPY GUIDELINES.
STANDARDS OF QUALITY
Para la citación de la presente AEPCC-Guía se hará constar:
AEPCC-Guía: COLPOSCOPIA. ESTÁNDARES DE CALIDAD. Coordinador: Torné A. Secretaria: del Pino M. Autores: Andía D.,
Castro M., de la Fuente J., Hernández J.J., López J.A., Martínez J.C, Medina N., Quílez J.C, Ramírez M., Ramón y Cajal J.M.
Publicaciones AEPCC. 2018; pp: 1-80.
ISBN 978-84-09-06631-5 Copyright@ AEPCC 2018
1. RATIONALE AND OBJECTIVES
The principal objective of the Spanish Association of Cervical Pathology and Colposcopy (AEPCC) is to “promote knowledge
and investigation of the lower genital tract in women”. The “AEPCC-Guidelines” were developed to fulfill this objective and to
respond to the demand of professsionals devoted to disease of the lower gential tract and colposcopy.
The AEPCC-Guidelines cover specific areas of knowledge of disease of the lower genital tract which are characterized by
their relevance and important repercussion in clinical practice. The AEPCC-Guidelines are scientific evidence-based documents
which have been systematically developed and aim to help professionals achieve consensus in decision making in clinical practice
regarding the most adequate diagnostic and therapeutic options for a determined health problem.
The specific objectives pursued by the AEPCC-Guidelines are:

• To promote standardized lines of action based on the current scientific evidence and reliable consensus information.
• Guarantee patient equality when attended, independently of their location of residence, promoting good praxis.
• Improve the effectiveness of interventions and the quality of health care.
• Favor the implementation of indicators of quality control or of clinical efficacy.
• Facilitate decision making within the administrative setting for managers or health care resources planners.
Lastly, the methodological rigor established for the preparation of the AEPCC-guidelines is aimed at the development of
documents of outstanding scientific quality which will allow better clinical practice and greater knowledge of lower genital tract
diseases.
2. METHODOLOGY
The specific methodology followed for the elaboration of the AEPCC-Guidelines includes the following aspects:
• The AEPCC Steering Committee appoints a Coordinator who is responsible for the elaboration of the AEPCC-Guidelines.
In accordance with the Steering Committee, the Coordinator appoints the Writing Committee consisting of him/herself, a
Secretary and the participants. The members are professional experts who are members of the AEPCC or other scientific
societies with recognized prestige in this topic.
• Consensusal development of the index.
• Critical review of the available literature and assignment of levels of evidence.
• Discussion and consensus among the members of the Committee for assigning the grade of recommendation.
• Elaboration of the document.
• Final analysis of the document on behalf of the Review and Editing Committee.
• Printed and online format of the final version.
• Diffusion of the AEPCC-Guidelines in congresses, courses and seminars organized by the AEPCC.
• Elaboration of online Courses of Continuing Education on the content of the AEPCC-Guidelines to provide in depth knowlege
of the guidelines and facilitate their application in daily clinical practice (training credits).
• Translation of the AEPCC-Guidelines to English (online edition).
• Update of the AEPCC-Guidelines.
AEPCC-Guías
3. EVALUATION OF THE SCIENTIFIC EVIDENCE.

CRITERIA FOR ESTABLISHING STANDARDS OF QUALITY
The “Guidelines of Clinical Practice” consist of recommendations aimed at health professionals to help them with patient care
related to a determined clinical condition. They are based on the most important bibliographic evidence of a determined subject
(systematic reviews of the medical literature and identification of studies with the greatest scientific evidence available) and
on clinical practice. In general, the highest level of classification is given to prospective studies to which patients are randomly
assigned, and the minimum levels are given to data related to expert opinion. In this way it is possible to assess the quality of
evidence associated with the results obtained by a determined strategy. For the elaboration of the AEPCC-Guudelines all the
recommendations made have considered the quality of the current scientific documents. The strength of the recommendations is
agreed upon by the Committee of the AEPCC-Guidelines based on the quality of the studies available.
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COLPOSCOPY GUIDELINES STANDARDS OF QUALITY
INDEX
1.INTRODUCTION..........................................................8 gynecological examination.............................................. 16
2. SAMPLE COLLECTION FOR SCREENING OF 3.2.1 Women with symptoms suggestive
CERVICAL CANCER...................................................... 9 of cervical cancer (CC)................................................ 16
2.1 Cytology smears collection....................................... 10 3.2.2 Macroscopically abnormal cervix at the
2.1.1 Material and methods..........................................11 moment of screening test sampling............................. 17
2.1.2 Reports................................................................11 3.3 Waiting time between confirmed histological
2.2 Sample collection for HPV testing.............................11 diagnosis by colposcopy and treament........................... 17
2.2.1 Material and methods..........................................11
2.2.2 Reports................................................................11 4. COLPOSCOPY INSTRUMENTS
2.3 Sample collection in special clinical situations..........12 AND MATERIAL..............................................................18
2.3.1 Cervical stenosis.................................................12 4.1 Colposcope............................................................... 18
2.3.2 Cervicitis, leukorrhea, contaminants................... 12 4.1.1 Elements making up a colposcope..................... 19
2.3.3 Severe atrophy....................................................12 4.1.2 Colposcope accessories..................................... 19
2.3.4 Previous hysterectomy........................................13 4.2 Instruments or colposcopy consultation.................... 19
2.3.5 Previous radiotherapy......................................... 13 4.2.1 Instruments for colposcopy access
2.3.6 Absence of endocervical cells or cells and viewing.................................................................. 19
from the transformation zone....................................... 13 4.2.2 Fungible material.................................................20
2.3.7 Repeated inflammatory or hemorrhagic 4.2.3 Instruments for the collection of histological
cytology results............................................................ 13 samples........................................................................20
4.2.4 Other materials....................................................20
3. GUIDELINES FOR REFERRING A PATIENT TO 4.3 Acetic acid................................................................. 20
COLPOSCOPY. STANDARDS OF QUALITY................. 14 4.4 Lugol solution............................................................ 21
3.1 Waiting time to perform colposcopy in 4.5 Hemostatic solutions................................................. 21
asymptomatic patients with abnormal screening 4.6 Maintenance of colposcopy material.........................22
study results................................................................... 14
3.1.1 Cytology showing atypical squamous cells 5. NOMEMCLATURE AND DESCRIPTION OF
of undetermined significance (ASCUS)........................14 COLPOSCOPIC FINDINGS............................................23
3.1.2 Cytology showing low grade squamous 5.1 Terminology............................................................... 23
intraepithelial lesion (LSIL)...........................................14 5.2 Accuracy of colposcopic diagnosis............................23
3.1.3 Cytology showing high grade squamous 5.3 Benefits of colposcopy...............................................26
intraepithelial lesion (HSIL).......................................... 15 5.4 Potential harmful effects of colposcopy.....................27
3.1.4 Cytology showing atypical squamous cells
which cannot rule out a high grade lesion (ASC-H)..... 15 6. STANDARDS OF QUALITY IN COLPOSCOPIC
3.1.5 Atypical glandular cells (AGC) which cannot DIAGNOSIS.................................................................... 29
rule out high grade lesion (AGC-H)..............................15 6.1 Registry of the clinical history of patients referred to
3.1.6 Cytology of adenocarcinoma in situ (AIS) colposcopy...................................................................... 29
or carcinoma................................................................ 16 6.1.1 Anamnesis (pathological, gynecological
3.1.7 Positive HPV test and negative cytology.............16 and obstetric history)....................................................29
3.2 Waiting time to perform colposcopy in patient 6.1.2 Indication for performing colposcopy.................. 29
with symptoms or with suspicious findings on routine 6.1.3 Verbal information and informed consent........... 29
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AEPCC-Guías
6.2 Colposcopic examination.......................................... 30 7.5.1 Training and certification of colposcopists.......... 45

6.2.1 Cervical examination...........................................30 7.5.2 Content of the training and evaluation................ 45
6.2.2 Vaginal examination............................................31 7.5.3 Maintenance of clinical skills and continuing
6.2.3 Vulva examination...............................................31 medical education (CME)............................................ 46
6.3 Reporting and registry of colposcopic findings......... 31
6.3.1 Description of colposcopic findings.....................31 8. INFECTIONS, CYTOLOGY AND COLPOSCOPY..... 47
6.3.2 Registry of colposcopic data and images 8.1 Sample collection for the study of infection
(diagrams, photos)....................................................... 32 in the colposcopy visit..................................................... 47
6.3.3 Reporting of colposcopic impression.................. 33 8.2 Action towards infection found in the cytology.......... 47
6.4 Colposcopy-guided biopsy........................................ 33 8.2.1 Actinomyces....................................................... 47
6.4.1 Adequacy of the biopsies.................................... 33 8.2.2 Tricomas vaginalis.............................................. 47
6.4.2 Number of biopsies............................................. 34 8.2.3 Candida species................................................. 48
6.4.3 Cervical biopsy sampling according to 8.2.4 Bacerial vaginosis.............................................. 48
level of risk................................................................... 35 8.2.5 Chlamydia tracomatis......................................... 48
6.4.4 Non-guided biopsies........................................... 36 8.2.6 Neisseria gonorrhoeae....................................... 49
6.4.5 Endocervical study (biopsy with cytological 8.2.7 Herpes Simplex Virus (HSV)...............................49
curettage or smear)......................................................36 8.3 Informing patients of the results................................ 49
6.5 Reporting and registry of diagnosis after
colposcopy and treatment...............................................37 9. COLPOSCOPY STANDARDS IN SPECIAL
6.5.1 Localization, number of biopsies and SITUATIONS...................................................................50
characteristics of the areas selected for biopsy........... 37 9.1 Pregnancy................................................................. 50
6.5.2 Endocervical study (biopsy with curettage 9.2 Menopause............................................................... 51
or cytological smear)....................................................38 9.3 Use of contraceptives............................................... 51
6.6 Informing the patient of the results and follow-up..... 38 9.4 Hysterectomy............................................................ 51
7. COLPOSCOPY UNITS. STANDARDS OF QUALITY 10. COLPOSCOPIC PRACTICE ACCORDING

AND RECOMMENDATIONS.......................................... 39 TO THE LEVEL OF RISK............................................... 53
7.1 Standards of quality of Colposcopy Units................. 39 10.1 Definition of risk of premalignant cervical lesion..... 53
7.1.1 Coordination and management of 10.2 Colposcopic practice in women with low risk
the Colposcopy Unit.....................................................39 of premalignant lesion.................................................... 55
7.1.2 Quality control of the Colposcopy Unit................39 10.3 Colposcopic practice in women with high risk of
7.1.3 Information and communication with premalignant leison......................................................... 56
the patient.....................................................................41
7.1.4 Certification......................................................... 42 11. TABLES SUMMARIZING REOMMENDATIONS
7.1.5 Coordination of screening programs...................42 AND STANDARDS OF QUALITY IN COLPOSCOPY..... 58
7.2 Personnel, installations and equipment
in the Colposcopy Unit.................................................... 42 12. REFERENCES......................................................... 70
7.2.1 Staffing................................................................42
7.2.2 Installations and equipment................................ 43
7.3 Organization and administrative management......... 44
7.3.1 Organization and meetings of the Colposcopy
Unit and with multidisciplinary teams.......................... 44
7.4 Clinical documentation..............................................44
7.4.1 Clinical history..................................................... 44
7.4.2 Data.................................................................... 44
7.5 Colposcopy training, certification and
continuing medical education..........................................45
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Participants COLPOSCOPY GUIDELINES STANDARDS OF QUALITY
COORDINATOR SECRETARY
Dr. Aureli Torné Dra. Marta del Pino
Unidad de Ginecología Oncológica, Instituto Clínico Unidad de Ginecología Oncológica, Instituto Clínico
de Ginecología y Obstetricia y Neonatología (ICGON), de Ginecología y Obstetricia y Neonatología (ICGON),
Hospital Clínic. Hospital Clínic.
Instituto de Investigaciones Biomédicas August Pi i Instituto de Investigaciones Biomédicas August Pi i
Sunyer (IDIBAPS), Facultad de Medicina, Universidad de Sunyer (IDIBAPS), Facultad de Medicina, Universidad de
Barcelona, Barcelona Barcelona, Barcelona
AUTHORS
Daniel Andía José Antonio López
Servicio de ginecología y Obstetricia, Hospital Universitario Servicio de Obstetricia y Ginecología, Hospital General
Basurto, UPV, Bilbao. Universitario de Alicante, Alicante.

María Castro
Servicio de Obstetricia y Ginecología. Hospital Luís María Puig-Tintoré
Universitario Puerta de Hierro, Madrid. Facultad de Medicina, Universidad de Barcelona,
Barcelona.
Jesús de la Fuente
Servicio de Ginecología y Obstetricia. Hospital José Cruz Quílez
Universitario Infanta Leonor, Madrid. Servicio de Ginecología y Obstetricia del Hospital
Universitario de Basurto. Bilbao
Juan José Hernández
Servicio de Ginecología y Obstetricia. Hospital Mar Ramírez
Universitario Infanta Leonor, Madrid. Unidad de Ginecología Oncológica. Instituto de Salud de
la Mujer José Botella Llusiá. Hospital Clínico San Carlos.
Juan Carlos Martínez-Escoriza Facultad de Medicina, Universidad Complutense, Madrid.
Servicio de Obstetricia y Ginecología, Hospital General
Universitario de Alicante, Alicante. José Manuel Ramón y Cajal
Servicio de Ginecología y Obstetricia. Hospital San Jorge,
Norberto Medina Huesca.
Unidad de Patología del Tracto Genital Inferior. Complejo
Hospitalario Universitario Materno Insular de Canarias,
Las Palmas de Gran Canaria.
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AEPCC-Guías
1. Introduction
Colposcopy is an essential study in the secondary been granted. One registry of colposcopic activity estimated
prevention of cervical cancer (CC) and for evaluation of the that in Spain 45% of Colposcopy and Lower Genital Tract
lower genital tract. It is the only procedure able to identify Disease Units have one or two accredited professionals,
intraepithelial cervical lesions, determine their localization and 20% have three or more accredited specialists.
and characteristics and guide biopsy for diagnostic
confirmation. Therefore, most patients with abnormal One fundamental aspect of colposcopic practice is the
results in screening tests require colposcopic evaluation. need to use standardized terminology for understanding
Since 2014, the Spanish Association of Cervical Pathology and evaluating colposcopy results. There are multiple
and Colposcopy (AEPCC) has promoted and published the classifications and descriptions of colposcopic findings
AEPCC-Guidelines on cervical cancer (CC) screening and but the terminology recognized as “official”, and which
the actions to be taken with abnormal screening test results. should thus, be systematically applied in all studies is the
These guidelines clearly establish when a colposcopy terminology described by the International Federation of
should be performed or repeated in both the diagnosis and Cervical Pathology and Colposcopy (IFCPC) [1].
follow-up or treatment of precursor lesions of CC.
On the other hand, colposcopies and the criteria for
The central role that colposcopy plays in the prevention performing biopsies should not be uniform for all women
of CC advocates the importance of having a standardized presenting alterations in screening tests. For years, the
procedure, the need for colposcopy procedures to be algorithms of action in these patients follow the concept
uniformly performed in clinical practice and the availablity of of “stratification of risk” so that the action varies based on
indicators of quality for evaluation. the risk of the patient presenting a high grade squamous
intraepithelial lesion (HSIL/CIN2-3). Performing the same
In Spain and in most countries with CC screening programs colposcopic procedures in women with very different risks
there is a great lack of uniformity in the performance of could lead to overdiagnosis/overtreatment in some cases or
colposcopy. Hundreds or thousands of gynecologists underdiagnosis/undertreatment in others.
in Spain carry out colposcopies in very diverse settings
(primary care, county hospitals, regional hospitals, level 3 Lasty, in addition to establishing how to carry out a
hospitals). colposcopy, indicators of quality of all the process should
be established which clearly define not only the minimum
Some professionals do a type of basic colposcopy and very requirements but also the optimal health care levels.
sporadically (very few times a month), while others perform Undoubtedly, it is crucial to have indicators of quality when
advanced colposcopy (in well organized Colposcopic and evaluating colposcopy practice and to therefore continue
Lower Genital Tract Disease Units) almost exclusively and improving our health care activity or to certify that both the
with a large volume of examinations. Therefore, there is a specialists in Colposcopy Units and the units themselves
great variability in the experience and training of different achieve the desired level of excellence.
colposcopists. Some have received minimum training
during medical residency, while others have attended basic The present AEPCC-Guidelines on “Colposcopy and
courses or congresses and still others have participated in Standards of Quality” should embody an obligatory
advanced courses and/or have obtained specific training. benchmark for both colposcopists and Colposcopy Units in
Spain. These Guidelines describe most of the areas involved
Since 2007, the AEPCC provides “accreditation” which in the practice of colposcopy: instruments, material, sample
recognizes the experience (years of specific work in collection, guidelines for patient referral, classification and
colposcopy), the curricular merits in this setting or the global terminology, colposcopy practice according to the level
knowledge in colposcopy and disease of the lower genital of risk, standards and indicators of quality in colposcopy
tract (accrediation exam). To date, 464 accreditations have diagnosis and in the organization of Colposcopy Units.
8
The AEPCC hopes that these Guidelines will decisively to achieving the fundamental objective of the AEPCC which
contribute to increasing the quality of health care in the consists in improving the training of professionals and
practice of colposcopy and facilitate evaluation of this patient care within the setting of the prevention of cancer of
procedure at both an individual level as well as in Colposcopy the lower genital tract.
Units. Any advance in this sense will undoubtedly contribute
2. Sample collection for screening of cervical cancer

2.1. CYTOLOGY SMEARS
COLLECTION Recommendation:
• Ideally the cytological smear should be done
The objective of cytological cervical sample smears is to when the patient is not menstruating.
obtain cells from the transformation zone (TZ) which is • On the presence of signs of suspicion of an inva-
where most premalignant lesions are found. sive cervical lesion the patient should be referred
to a specialized unit for specific gynecological
Before describing cytological smear collection in depth, study.
it is important to note that if clinical signs suggestive of

malignancy are observed when taking the smear, a biopsy
sample should be taken or the woman should be referred
to specialized gynecological consultation for closer study
independently of the cytology results [2].
The days of the menstrual cycle should be taken into

account when obtaining a cervical smear. The number of
unsatisfactory cytologies significantly increases in smears
obtained in the presence of bleeding, and therefore
cytological smears should preferably be performed when
the patient is not menstruating. However, it is important to
consider that it is always better to perform the screening
during menstruation than not to do the screening [3, 4].
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AEPCC-Guías
2.1.1. Material and methods American clinical guidelines. There are several reasons
which justify the preference for liquid cytology. On one
Prior to sample collection, the whole of the cervix should hand, liquid cytology allows the possibility of automatizing
be exposed and macroscopically assessed with the use of the processing and reading. In addition, the liquid medium
a speculum. The cytology smear should obtain a sample of techique can eliminate the erythrocytes, and thus, the
the external surface (ectocervix) and of the cervical canal difficulty of obtaining smears in cases with vaginal bleeding
(endocervix). is less relevant, thereby reducing the rate of inadequate
samples. Another important advantage of liquid cytology is
Two devices have traditionally been used (a spatula for the the possibility of using the same material for the cytological
exocervical smear and a cotton swab or a cytobrush for the study and to carry out molecular determinations such as
endocervical smear). At present, there are also sampling human papilloma virus (HPV) detection, the HPV genotype
devices with which a single smear of the exocervix and or dual p16/Ki76 staining [7].
endocervix can be made. Both methods are effective. If the
smear is done with the single device (for collection of exo-
Recommendation:
and endocervical material) it is advised to center the device
on the cervix and turn the bristles at least 5 times on the
• A cytological smear should obtain samples of the
exocervix and the endocervix.
specimen [5]. For separate smears, the spatula is applied
on the ectocervix and may be of wood or plastic, although
• Cytological smears should preferentially be
the latter material seems to be preferable for reading in done in liquid medium with a plastic spatula or
liquid medium. The cytobrush collects material from the cytobrush or with a single sampling device.
endocervix, and it preferred over cotton swabs [6]. Conventional smears on slides are acceptable.
The transfer of the cervical smear differs according to

whether conventional or liquid cytology is performed. For
the conventional or classical cytology on a slide, the material
obtained from the ectocervix should be carefully extended
on the first half of the glass. Then, it is extended on the
second half of the slide perpendicular to the former material
collected with the cytobrush, slowly turning it on the glass.
The material placed on the glass should occupy the whole
surface but should not be lumpy or have a thick layer since
reading will be inadequate in these areas. After depositing
the sample, this should be fixed with a spray, applied at a
distance of 15.20 cm so that a homogeneous layer remains
on the sample avoiding smearing of the sample.
In the case of liquid cytology, the spatula and the cytobrush

or the single sampling device are introduced into the
preserving transportation fluid and shaken vigorously for
several seconds so that the exfoliated cells become loose
and remain in suspension. If the smear is made with the
single sampling device with plastic bristles, the device
should be pushed against the bottom of the vial 4-5 times
in order to separate the bristles and for the material to fall.
Both the classical cytology on slides and liquid cytology are

acceptable methods for screening, although the technology
in liquid medium is preferable in most European and
10
2.1.2. Reports More than 140 methods for HPV detection are available.
At present, only 4 have been approved by the Food and
The cytology report should include: Drugs Administration (FDA) for the detection of HPV for
• A description of the type of study: conventional, liquid health care purposes: Hybrid Capture, Cervista, Cobas
medium and/or HPV test. 4800 and APTIMA [10]. The Cobas 4800 is the only method
• Whether the sample is adequate or not. approved by the FDA and the European Medicines Agency
• Interpretation of the result.
(EMA) for populational screening. Among the multiple
• A description of any auxillary test or automatic revision
methods of HPV determination, their validity for clinical use
made and the notes or suggestions of the pathologist.
is accepted provided that there is an optimal balance of
clinical sensitivity and specificity for the detection of ≥HSIL/
In 1988 the terminology for reporting the cytology result
CIN2 similar to that demonstrated in clinical studies with
was standardized using the Bethesda system, having been
hybrid capture (reference test) [14, 15].
reviewed on several occasions, the last being in 2014
[8]. The Bethesda terminology is considered the “official”
terminology to describe cytological findings. Recommendation: Tests to determine HPV must
be approved by regulating agencies (FDA and/or
Squamous cell abnormalities are reported using the term EMA) or fulfill the criteria of equivalence of sensitivi-
“SIL” meaning squamous intraepithelial lesions [9]. Since ty and specificity.
1988, cytological SIL alterations have been divided into two
categories based on a different prognosis: LSIL (low grade
squamous intraepithelial lesion) usually corresponds to 2.2.1 Material and methods
low histological grade lesions (LSIL/CIN1) and HSIL (high
grade squamous intraepithelial lesion) is most frequently The samples for HPV testing should be obtained from the
associated with high grade histological lesions (HSIL/ endocervix and the TZ using the spatula and the cytobrush
CIN2-3) and cancer. The results of the cytology test do not or the single sampling device in a similar way to cytology
represent a definitive diagnosis since this should always smear collection (see section 2.1.1). The material is
be confirmed by histology. The definitive diagnosis should deposited in the transport medium.
always be made by colposcopy-guided biopsy.
Most liquid cytology systems can use the same specimen
The time from sample collection and the availability of the for HPV determination. There are other methods of self-
cytological report should not exceed 6 weeks [10]. collection or HPV testing in urine, but at present their use
has no clinical application.
Recommendation: cytological reports should be

made according to the Bethesda terminology. Recommendation:
• Smears for HPV determination should be obtai-
ned from the endocervix and the transformation
zone.
2.2. SAMPLE COLLECTION FOR HPV • Smears for HPV determination should be obtai-
TESTING ned in liquid medium with a plastic spatula and
cytobrush or with a single sampling device.
The determination of HPV in screening has the principal
advantage of increasing the sensitivity and efficacy
compared with cytology and can increase the interval
2.2.2 Reports
between smears [11, 12]. The lower specificity of this
The tests for HPV testing may be used as a primary tool
screening method may be compensated by the selection
for CC screening (exclusively or as a co-test if HPV testing
of HPV positive patients by reflex cytology and the study
and cytology are performed together), or as a reflex test
of molecular biomarkers related to HPV infection [10, 13].
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AEPCC-Guías
after an abnormal cytology result such as, for example an

ASCUS [16]. In the latter case, the extra transport liquid Recommendation: In cervical stenosis an endo-
of the cytology study is used to determine the presence of cervical smear may be performed after dilatation. In
difficult cases it is preferable to obtain a smear for
HPV.
the HPV test.
The information provided in the HPV test reports depends on

the test used. The HPV tests approved by the FDA include
2.3.2 Cervicitis, leukorrhea, contaminants.
hybrid capture (Hybrid Capture® 2 [HC2]), Cervista® HPV
HR Test and APTIMA® HPV Test, which group the results
In the case of abundant leucorrhea, the surface of the cervix
for all high risk HPV types (that is, reports a positive result
may be gently cleaned with a swab eliminating the excess
if any high risk type is present but does not describe any
of vaginal secretion and mucosity before performing the
specific type). Cobas 4800 especially identifies HPV types
cytology test without interfering with the results. Cytology can
16 and 18 and groups the result of the other 12 high risk
identify several infectious agents which cause leukorrhea
types (high risk HPV other than 16/18). This latter test is the
(for example, Actinomyces, Tricomonas vaginalis, candida,
only HPV test explicitly approved for screening. Other tests
herpes virus), but it is not a method to diagnose alterations
which are currently marketed fulfill the prevailing requisites
in vaginal secretion. On signs of cervicitis it is preferable to
for their use in populational screening [10].
carry out local and/or systemic, empiric or specific treatment
after fresh smear or culture, and after several weeks the
screening sample can again be attempted.
Recommendation: Depending on the method cho-
sen, reports of HPV test results in primary scree-
The use of a lubricant prior to introducing the speculum
ning will provide information about a positive high
risk HPV result or report the specific genotype or the has no adverse impact on the interpretation of the classical
positivity for HPV 16 and 18 genotypes. cytology and has been evaluated in several studies [18, 19].
In general, it is logical to think that the sample in liquid

medium is less affected by leukorrhea or other vaginal
2.3 SAMPLE COLLECTION IN SPECIAL contaminants (creams, semen, etc.) than the classical glass
CLINICAL SITUATIONS sample.
Some situations may present specific characteristics. Each

Recommendation: In cases of cervicitis it is prefe-
patient should be considered individually and adopting
rable to delay cervical sampling until after under-
the strategies necessary for correct sample collection is going specific treatment.
fundamental for cytologic evaluation.
2.3.1 Cervical stenosis 2.3.3 Severe atrophy
Severe cervical stenosis (often as a result of previous In post menopausal patients atrophy may hinder sample
surgery) frequently impedes cytological sample collection taking and impede endocervical sampling, thereby increasing
of the complete transformation zone. Access to the cervical the number of inadequate cytologies due to an absence
canal can be achieved by cervical traction with Pozzi forceps of cylindrical epithelial cells or of the transformation zone.
and/or cervical dilatation [17]. Another option is to perform Treatments with local estrogen or even with misoprostol
the cytological smear after dilatation maneuvers. In difficult have been proposed to facilitate endocervical access and
cases in which scarce material is collected, it is preferable repeat the sampling [19, 20]. At present, HPV detection
to obtain a smear for HPV testing [10]. is the reference technique for this limitation. If the cytology
does not show abnormalities and the HPV test is negative,
the screening is assumed to be normal. In special cases or
in cases in which repeated samples have been deficient,
estrogen treatment may be administered in order to repeat
sample collection after 6-8 weeks [12, 17].
12
2.3.6 Absence of endocervical cells or

Recommendation: In cases of severe atrophy cells from the transformation zone
treatment with topical estrogens may be administe-
red before the cytology or HPV testing.
In cases in which the cytology results show an absence
of endocervical cells or cells from the transformation
2.3.4 Previous hysterectomy zone, in the absence of other abnormalities, the result is
considered negative provided that the sample is adequate
Patients undergoing total hysterectomy with no previous for evaluation.
history of SIL/CIN should not continue with the screening

[2], since primary cancer of the vagina is the least frequent When the cytology is reported as inadequate for evaluation,
of the genital tract (0.69 cases per 100,000) [21]. The several possibilities may be considered: 1) perform a
frequency is comparable to breast cancer in males or penile HPV reflex test in the same sample (if this is negative it
cancer. can be assumed that the screening is negative); 2) if HPV

determination is not available treatment with estrogens may
Different studies including more than 10,000 women with be carried out and the sample repeated (ideally the co-test)
hysterectomy due to benign disease found a reduced in 6-8 weeks [17].
number of cases of vaginal SIL (less than 1%) and no case

of vaginal cancer after a follow-up of up to 20 years [22- If the cytology is repeatedly inadequate for evaluation
25]. Therefore, independently of age, screening for the because of an absence of endocervical cells or cells from
detection of cancer of the vagina with any technique is not the transormation zone, the patient should be referred to
justified in patients with no history of SIL/CIN undergoing colposcopy.
hysterectomy.
Recommendation: Cytology results without cellular

Women with a history of a lesion ≥ HSIL/CIN2 treated or
alterations reported as “adequate but limited by the
spontaneously resolved continue to have a 5 to 10-fold
absence of endocervical cells or cells from the trans-
greater risk of developing CC within the following 20 years
formation zone” are considered to be negative.
than the general population [10]. These patients should
therefore continue screening. A plastic spatula is used to
obtain the cytology sample and/or for determination of HPV 2.3.7 Repeated inflammatory or
from the vaginal fundus. In cases of subtotal hysterectomy, hemorrhagic cytology results
screening is the same as in women with an intact uterus.
Inflammatory or hemorrhagic cytology results are more
frequently reported when conventional cytology is used. In
Recommendation: women with hysterectomy due
some cases, this alteration conditions inadeqaute sampling.
to SIL/CIN should continue to be screened for at
Cytology samples in liquid medium minimize the number
least 20 years.
of inadequate samples due to inflammation of hemorrhage.
2.3.5 Previous radiotherapy However, in either case, this result implies a lower sensitivity,
and therefore, there is a possibility that an inflammatory
There is no evidence as to which strategies are the most or hemorrhagic sample may underdiagnose premalignant
ideal in women undergoing radiotherapy for cancer of lesions of the uterine cervix.
the cervix, rectum, bladder or other pelvic organs. These

cases are not submitted to standard screening protocols In a study including 420 samples, 30 (8.6%) showed
and individualized clinical gynecological control should be persistent inflammatory changes at one year. These patients
implemented [2]. were referred to colposcopy which found four cases of LSIL/
CIN1 (13.3%) and one case of HSIL/CIN2 (3.3%) [26].
13
AEPCC-Guías
If the cytology is inadequate due to inflammation or perform HPV testing and act according to the result obtained
hemorrhage, the sample should be repeated after specific [2]. If an HPV test is not available the patient should be
treatment. In cases with three inadequate cytologies due referred to colposcopy.
to inflammation or hemorrhage the preferable option is to
3. Guidelines for referring a patient to colposcopy.

Standards of quality.
3.1 WAITING TIME TO PERFORM 3.1.1 Cytology showing atypical

COLPOSCOPY IN ASYMPTOMATIC squamous cells of undetermined
PATIENTS WITH AN ABNORMAL significance (ASCUS)
SCREENING TEST RESULT
This is the most common cytological alteration. The global
With abnormal cervical screening test results a colposcopic prevalence of HPV infection in women with ASCUS ranges
examination should be performed as well as evaluation of from 33-51% [27] and varíes based on age. The presence
the lower genital tract [27]. Depending on the organization of lesions ≥HSIL/CIN2 in women with ASCUS cytology
of health care and screening, the patient is referred to a results with a positive HPV determination is between 5-12%
specific unit for performing this study. It is very important to and between 0.1-0.2% for CC [27].
ensure that the time between the screening test results and
the colposcopic examination does not imply a worsening In the different guidelines published it is described that in
in the prognosis, especially in cases of greater risk or on cases with an ASCUS cytology that is positive for the HPV
suspicion of invasive lesions. Some studies have shown test, the recommended evaluation time should be between
that the prognosis of an underyling malignant lesion 6 and 12 weeks [2, 30].
is directly related to a delay in implementing adequate

treatment [2, 28-30].
Recommendation: colposcopic evaluation of a pa-
tient with ASCUS cytology and postive HPV results
The risk of a severe cervical lesion largely depends on
should be performed within 8 weeks.
the abnormality found in the screening test. This aspect
conditions the recommended interval of time to perform the
evaluation of the patient. 3.1.2 Cytology with low grade squamous
intraepithelial lesion (LSIL)
In this regard, there are many publications in which the
recommendations are not completely homogeneous and LSILs are found in 2-3% of all cytological studies.
are based on territorial health care policies [30]. Approximatey 12-16% of these alterations correspond to a
lesion ≥HSIL/CIN2 after a colposcopy and biopsy study [27],
In general, earlier evaluation is recommended for more and the risk of CC is estimated as having a grade similar
severe abnormalities (alterations ≥ HSIL/CIN2) compared to to the ASCUS cytological result [31]. The National Health
alterations of a lesser grade. Nonetheless, most guidelines Service (NHS) and the American Society for Colposcopy
recommend that women with abnormal detection tests and Cervical Pathology (ASCCP) recommend that in these
should be evaluated within a “reasonable time” taking into cases a colposcopic examination should be performed
account not only the risk of high grade lesions or underlying within 6 to 12 weeks [2, 30].
cancer but also the emotional stress associated with waiting
when screening test results are abnormal [29].
14
Recommendation: Colposcopic evaluation should Recommendation: Colposcopic evaluation should

be performed within 8 weeks in a patient with LSIL be performed within 4 weeks in a patient with ASC-H
cytology. cytology.
3.1.3 Cytology showing high grade 3.1.5 Atypical glandular cells (ACG)
squamous epithelial lesion (HSIL) that cannot rule out a high grade lesion
(ACG-H)
This cytological result is found in 0.5 to 1% of all screening
cytologies. The finding of atypical glandular cells (AGC) is very
infrequent, representing approximately 0.4% of all
In cases with a cytology of HSIL, the definitive histological cytologies, and they are associated with a wide range of both
diagnosis shows a lesion ≥ HSIL/CIN2 in approximately 60% benign and malignant alterations [27]. The nomenclature
of the cases and CC in 2% [27]. Taking into account the high establishes several terms attempting to orient the origin of
risk of the presence of an underlying lesion ≥ HSIL/CIN2, the glandular elements found in the sample (endocervical,
there is wide consensus regarding the need to perform endometrial or non specific) or indicating the suspicion of
colposcopic evaluation within a period of no greater than malignant squamous disease (AGC-H).
4 weeks after the HSIL cytological result [2, 29, 30], which
would adjust the treatment time to within a safe interval. Although the term AGC suggests glandular pathology, this
result is more frequently associated with squamous cervical
lesions (SIL/CIN of any grade) than with glandular lesions,
Recommendation: Colposcopic evaluation should with there being an elevated probability of diagnosing lesions
be performed within 4 weeks in a patient with HSIL ≥ HSIL/CIN2 (9-54%) [27]. In general, in young women with
cytology. AGC-H cytology results there is a greater prevalence of
lesions ≥ HSIL/ CIN2, while in women over 35 years of age
a greater prevalence of glandular pathology is observed
3.1.4 Cytology showing atypical
squamous cells which cannot rule out a [27]. Glandular and squamous lesions can frequently
high grade lesion (ASC-H) coexist (half of the cases diagnosed with adenoma in situ
[AIS] are also diagnosed with CIN). Therefore, in cases with
The diagnosis of uncertain atypical squamous cells that AGC cytology the diagnosis of CIN does not totally exclude
cannot rule out a high grade intraepithelial lesion (ASC-H) an AIS or adenocarcinoma.
is also infrequent (between 0.27 and 0.6% of all screening

cytologies). This result represents a medium-term risk of Lastly, AGC can also be associated with carinomas not
lesions ≥ HSIL/CIN3 of 26 to 68% [27]. related to HPV. Thus, in cases with AGC cytology, a negative
HPV test does not totally exclude the possible presence of
There is no firm consensus in the literature defining the an invasive lesion. In these cases, a negative HPV test
time at which these ASC-H alterations should be evaluated. identifies a subgroup with greater risk of endometrial than
Nonetheless, considering the high probability of the cervical neoplasia [27].
presence of a severe underying lesion, rapid evaluation

times of between 2 to 6 weeks have been described in the In women with AGC or AGC-H cytologies, there is no
literature [2, 29, 30, 32]. consensus in the literature as to the time within which
these alterations should be evaluated. Nonetheless, in
view of the high probability of a severe underlying lesion,
rapid evaluation times of between 2 to 6 weeks have been
described [2, 29, 30, 32].
15
AEPCC-Guías
Recommendation: Colposcopic evaluation should Recommendation: Colposcopic evaluation of

be performed within 4 weeks in a patient with AGC patients with negative cytology and a persistent
or AGC-H cytology. positive HPV test for at least one year should be
performed within 16 weeks.
3.1.6 Cytology showing adenocarcinoma

in situ (AIS) or carcinoma
3.2 WAITING TIME TO PERFORM
This cytology result suggests the possible presence of a very COLPOSCOPY IN PATIENTS WITH
severe or invasive squamous or glandular cervical lesion, SYMPTOMS OR WITH SUSPICIOUS
and therefore, cervical evaluation by colposcopy should FINDINGS IN THE ROUTINE
be performed as soon as possible. The guidelines recently GYNECOLOGICAL EXAMINATION
published by different scientific societies recommend that
in no case should the colposcopy study be performed later On certain occasions we may find patients with a
than 2 weeks after the receipt of the cytological results [2, symptomatology suggesting the presence of a severe
29, 30]. cervical lesion, or an asymptomatic woman with a cervical
examination suspected of presenting CC (friable, with
ulcerated lesions, bleeding). With these findings the
Recommendation: Colposcopic evaluation should
patient should be referred to specialized consultation for
be performed within 2 weeks in a patient with AIS
colposcopic evaluation.
cytology
3.2.1 Women with symptoms suggestive

3.1.7 Positive HPV test and negative of cervical cancer (CC)
cytology
The symptoms which most often suggest an invasive
Patients with a positive HPV test and negative cytology process are [34]:
present a 5-10% risk of a lesion ≥ HSIL/CIN2 at 5 years. In • Spontaneous, irregular and repeated genital bleeding.
this case, there is no consensus as to the best therapeutic • Repeated bleeding during coitus.
attitude to be taken. However, a conservative approach of • Anomalous vaginal fluid (watery, mucoid, bad
repeating the HPV test at 12 months has shown a sensitivity smelling). Although it is not a specific finding and may
for detecting a lesion ≥ HSIL/CIN2 that is comparable to be confounded with symptomatology of vulvovaginitis,
immediate colposcopy and with the great advantage of it should be taken into account, especially if the patient
substantiallly reducing the number of colposcopies. presents negative cultures.
If the HPV test continues to be positive after one year, In these circumstances, if there is clinical suspicion of
colposcopy evaluation is indicated [27]. Here the review the presence of an invasive cervical lesion, the genital
of the standards has a lower grade of consensus. Some tract should be assessed immediately by performing
scientific societies recommend that the colposcopic a colposcopy. Most scientific societies recommend a
evaluation of these patients should not exceed more than colposcopic evaluation within a period of no greater than 3
26 weeks [30], while other socieities recommend that these weeks [2,29, 30].
women be evaluated within a period of 6 to 12 weeks
[2], since the risk of a HSIL/CIN2 lesion is similar to that
Recommendation: In patients with symptoms su-
presented by women with ASCUS and a positive HPV test
ggestive of CC colposcopic evaluation should be
or with LSIL [31, 33]
16
3.2.2 Macroscopically abnormal cervix in Among patients treated with excisional procedures:
the screening test sample • The percentage of cases with excision of a single
surgical piece should be greater than 80%.
In asymptomatic cases in which the cervical examination • The proportion of severe hemorrhagic complications
suggests the presence of a malignant lesion, the possibility (requiring additional treament) should be less than
of performing cervical biopsy within the shortest time 5%.
possible or even at the same time as the screening should • The proportion of readmission due to treatment-
be evaluated if there is adequate material. related complications should be less than 2%.
In these women it is recommended to take a biopsy of the

Recommendation:
most suspicious area, attempting to avoid zones of necrotic
• All cervical treatments require a previous colposco-
appearance in which the histological evaluation normally
pic study performed in a Colposcopy Unit by spe-
does not achieve an adequate yield [34]. In addition,
cialized professionals.
endocervical curettage should be performed independently
• The treatment of HSIL/CIN2-3 should be carried out
of the result of the cervical cytology.
in less than 8 weeks.
• Excisional procedures should present less than 5%
If it is not possible to directly obtain a sample, the patient
of hemorrhagic complications and less the 2 % of
should be referred to the Colposcopy Unit within a period of
readmissions.
2 weeks [2, 29, 30].
Recommendation: Colposcopy should be perfor-

med within 2 weeks in women with a macroscopially
abnormal cervix in the screening sample.
3.3 Waiting time between confirmed

histological diagnosis and colposcopy
and treatment
All patients who are candidates to receive treatment should

previously undergo an exhaustive colposcopic study
performed by specialized personnel.
All the treatments of high grade premalignant lesions should

be carried out in centers of colposcopy units which are
adequately equipped and have specialized professionals.
The patients should be informed of the need for and type

of treatment and must give consent, preferably signed (if
consent is verbal, this should be reported in the clinical
history).
When treatment is indicated in women with HSIL/CIN2-3,

the procedure should be performed with a period of less
than 8 weeks.
17
AEPCC-Guías
4. Colposcopy instruments and material

4.1 COLPOSCOPY all colposcopes, and they act by impeding the
transmission of red light, highlighting the view of the
A colposcopy is a low resolution, stereoscopic, binocular, blood vessels located in the stroma and facilitating
field microscope which has a powerful light source and is evaluation of their characteristics.
used for visual examination of the cervix and the rest of the • Magnification: most colposcopes have a magnification
lower genital tract. The colposcope is an essential tool for changer and some make progressive magnification
the diagnosis of preneoplastic lesions. with zoom capacity. Usually low magnification is used
(x2 to x6) to evaluate the external genitals, a medium
The colposcope was designed by Hans Hisselmann in 1925 magnification (x8 to x15) is used for the vulva, vagina
with the aim of facilitating early detection of cervical changes and cervix) and a high magnification (x15 to x25) is
preceding the development of CC. Since then, this tool has used to assess fine, specific, details such as glandular
become a key tool for the secondary prevention of CC. In orifices, vascular patterns, etc. In general, the greater
the last years, colposcopes have advanced, improving the the magnification the lesser the field of view and the
resolution and adapting accessories in order to obtain, store lesser the illumination of the object of interest. In
and export videos and digital images.These improvements practice, a magnification greater than 15-20 is rarely
in the colposcopic images facilitate control of the quality of used.
the diagnostic or auditory images to evalate the efficacy of • Light source: Visualization of the cervix and vagina
the study as well as carry out teaching activities with high requires good illumination. Over the years many
resolution monitors [35]. types of light sources have been used and have
evolved in parallel with the technological advances
4.1.1 Elements making up a colposcope (incandescent light bulbs, tungsten halogen and arc
lamps). The current colposcopes have cold xenon
The head of the colposcope is the essential part of this or LED light which provides brighter illumination and
instrument and is made up of the following elements [36]: generates less heat. It is important for the light source
• Lens: colposcopes have two binocular lens situated of the colposcope to provide good illumination to
in straight optic tubes which allow adjustment of the whole field of observation, and therefore, it must
the dioptries to individually correct refraction errors. be potent, and it should be possible to adjust the
The angle of the binocular tubes in relation to the intensity to achieve adequate illumination to the area
observation line from the eye to the cervix can be to examined.The location of the lamp should also be
inclined (45º) or straight (180º). The focal distance or accessible to faciltate changing. In the colposcopes
the distance between the colposcope and the area currently available, the lamp is set outside the head
examined is determined by the curvature of the lens. It and the light passes through a fiber optic cable. This
is fundamental for the focal distance to be sufficiently cable allows the use of lamps of greater intensity.
long to introduce the instruments necessary to • Adjustable arm and stand: the head of the
obtain samples, biopsies or to perform treatments. colposcope is joined to the central axis and in turn
In general, colposcopes have an adjustable focal has an adjustable articulated arm which can move
distance of between 200 and 350 mm to easily adapt in all directions. The colposcope can be fixed to
any type of forceps or procedure. a examination table, set up on a pedestal or be
• Focus: the colposcope is focused by displacing adapted to a giratory arm subjects to the wall or
the head of the colposcope in relation to the patient ceiling. However, in general, the base is usually a
(macrometric focus) or using a focusing adjustment wide platform which acts as a counterweight and has
knob (micrometric focus). wheels for purposes of mobility.
• Filters: green or blue filters are available for
18
4.1.2 Colposcope accessories. 4.2.1 Instruments for colposcopy access

and viewing
In the last years many accessories have been adapted
to colposcopes to optimize examination of the anogenital In order to carry out a colposcopy examination it is
tract and visualize the images on monitors or to capture necessary to have material to achieve access to and
and transfer videos or digital images. Among all these expose the cervical and vaginal surface. The instruments
accessories the following are of note: which should be used are described below:
• Image capture systems of both standard and high • Vaginal speculum. This instrument is made up of two
definition. These systems can store, view and review valves with a mechanism to separate these valves and
the images at a later time. The resolutions now widen the opening or maintain it opened to provide
available range from 640×480 to 1920×1080 pixels. visualization of the whole cervix and vagina. There
• Tactile monitors, for the visualization and management are several valve separation and fixation systems.
of the digital colposcope systems. Vaginal speculums are available in diffferent lengths
• Integrated registry systems allow the acquisition and and widths.The most standard widths are 16, 24 and
availability of patient information. To do this, structured 36 mm, and the remaining are special sizes. Vaginal
databases, generally the SQL type, are used, which speculums may be metallic (reusable) or plastic
include the different examinations, images and videos (disposable). The metallic speculums are usually
in the same registry of the patient. covered with isolating material and may be available
• Tools for the integration of the information systems of in a fume extraction tube (usually used in surgical
the colposcope to the hospital information systems. procedures).
The information stored in the colposcope system • Vaginal retractor. With this instrument the lateral
can be integrated into the Picture Archiving and walls of the vagina can be retracted to facilitate view
Communication System (PACS) using Digital Imaging of the cervix. In determined patients, especially obese
and Communication in Medicine standards (DICOM) or pregnant women in the 2nd or 3rd trimester, the
or Health Level vaginal walls tend to prolapse on placement of the
• Seven (HL7). These systems not only satisfy the speculum, thereby making visualization of cervix
legal requisites regarding patient data protection, difficult. In extreme situations the vaginal walls may
but this archiving system also provides structured even totally hide the cervix. One alternative to the
management of each study performed allowing use of the vaginal retractor is to use a sheath of the
flexibility and facilty to follow the disease [37]. ultrasonographic vaginal probe or a condom to cover
the valves of the speculum. Once the speculum has
been placed or just before placement, a cut is made
4.2 INSTRUMENTS FOR at the point so that when the speculum is opened, the
COLPOSCOPY CONSULTATION sheath or condom impede the prolapse of the vaginal
walls towards the mid-line.
A colposcopy study requires a series of materials and • Endocervical speculum. This instrument allows
instruments to evaluate the lower genital tract. The objective visualization of the endocervical canal in cases in
of the instruments used in the colposcopy examination which the transformation zone is not completely
is to facilitate access and allow magnified inspection and viewed or a lesion which extends to the interior of
collection of samples for histologic study. the canal is identified. This speculum has two narrow
opposing valves of 1.5 to 2 cm which are placed
The instruments necessary to perform a colposcopy can be inside the external cervical orifice and are then gently
grouped into three categories: 1) material to faciliate access opened in order to observe the endocervial canal.
for colposcopic viewing, 2) fungible material, and 3) material
necessary to obtain samples.
19
AEPCC-Guías
4.2.2 Fungible material 4.2.4 Other materials
Swabs and gauzes are used to clean the flow or mucous Different instruments are often used to facilitate exposure
impeding correct colposcopic evaluation as well as to apply or traction of the tissue to be examined.
acetic acid and lugol solution in the study area. • Pozzi forceps: this instrument fixes the cervix. It is
useful in situations in which the biopsy forceps slip
4.2.3 Instruments for collection of on the epithelial surface or when the ligaments of the
histological samples pelvic floor are lax or there is uterine hypermobility.
• Hooks: these are hook-shaped metallic rods which
The colposcopic examination frequently determines are not sharp at the end in order to avoid tearing. They
the presence of lesions requiring histological study. The are especially useful in vaginoscopy of patients with
instruments necessary for doing biopsies are specific previous hysterectomy since they allow traction and
according to the area to undergo biopsy. visualization of the fundus of the vaginal pouch and
• Biopsy punch forceps: biopsy forceps are especially the angles of the colpotomy (dog ears). They also
designed to obtain small tissue samples (2-5 mm). facilitate punch forcep biopsy of lesions in smooth
They are formed by a handle and a biopsy head at the vaginal walls in which the punch biopsy alone cannot
distal end. This biopsy head is composed of a jaw with become fixed to the tissue to be extracted.
a part which punches and cuts. Different models are
comercialized (Burke, Kevorkian, Tischler, Schubert,
Schumaker etc.) with small differences in design, 4.3 ACETIC ACID
shape and jaw characteristics (round, oval, triangular,
square-shaped). With the wide availability of different • Composition: 3-5% glacial acetic acid in distilled
biopsy forcep models the biopsy can be individualized water [38]. Concentrations at 5% produce more rapid
adapting the histological sample to the characteristics and durable histological response than 3%.
of the cervix of the patient. • Mechanism of action: the exact mechananisms
• Endocervical curettage: This is performed to obtain of how acetic acid whitens the lesional areas are
histologial samples from the endocervical canal. The unknown. Two mechanisms which may occur together
instrument used is a hand-held curette which has a have been postulated. On one hand, acetic acid
handle to grasp and a slightly curved cutting head or temporally dehydrates the cells, reducing the nucleus/
end. A small indentation in the rod indicates alineation cytoplasm relationship. The refraction of the light on
of the instrument with respect to the distal cutting the surface of the cervix produces a visualization of
edge. The cutting edge may be rectangular and in the tissue, which is more intensive and prolonged
some models may have a basket in which the tissue according to the cellular density of the epithelium. On
obtained is collected. the other hand, it has been suggested that there may
• Dermatological punch: although this instrument is not be a possible precipitation or reversible coagulation
specifically used in biopsy sampling with colposcopy, it of cellular proteins such as cytokeratins and nuclear
is an essential tool for examination of the lower genital proteins. In dysplastic processes in which the nuclei
tract. This instrument has a circular hollow blade for are larger, there is more protein precipitation, and
obtaining histological material from vulvar-perineal therefore, less absorption of light, generating an
lesions. There are different sizes to obtain a cylinder acetowhite epithelium 39].
of cutaneous tissue of different diameters.The punch • Method of use: acetic acid may be applied using
is rotated in order to obtain a cylinder of tissue which a dampened swab or with direct instillation or
is extracted after excising the base. The biopsy should pulverization on the cervix. Acetic acid should act for
include all the dermoepidermal thickness. at least 20 seconds before withdrawal in order to see
acetoreactivity (speed at which the acetowhite images
appear). Depending on the grade of the lesion, more
20
or less waiting time will be needed for observing 4.5 HEMOSTATIC SOLUTIONS
abnormal images.
• Adverse effects: in general, acetic acid is well Biopsy of the cervix is a usual procedure in the study of
tolerated with only some cases presenting mild intraepithelial lesions. Bleeding is usually minimal and
irritation and itchincess which ceases spontaneously. self-limiting since tissue resection with the instruments
Allergic reactions are very rare. used does not usually exceed 5 mm of surface and 2 mm
of depth. The most frequent hemostatic products used
after biopsy are silver nitrate sticks and iron perchlorate or
4.4 LUGOL SOLUTION Monsel’s solution.
• Composition: Lugol iodine solution is composed of Silver nitrate sticks. These belong to the group of so-
potassium iodine (10 g), distilled water (100 ml) and called antiseptic and disinfectant medications. Although
iodine crystals (5 g) [37]. This solution is unstable at their indication in the summary of product characteristics is
room temperature and has an expiration period of 3-6 for warts and skin granulomas, mouth ulcers and epitstaxis,
months. they can also be used to perform hemostasis after cervical
• Mechanism of action: Lugol solution has avidity biopsy [39].
for glucogens found in the intermediate layer of • Composition: they are commercialized in the form
the squamous epithelium of the cervix and vagina, of plastic sticks of 2.4 mm in diameter and 9.5 cm in
producing a reddish-brown color which is more or less length with a small head of 42.5 mg of silver nitrate at
intense based on the quantity of glucogen in the cells. one of the ends.
Since the cylindric epithelium does not have glucogen, • Mechanism of action: induce hemostasis by
it does not present changes in color or presents a chemical cauterization.
very light brown color. The squamous epithelium of • Method of use: apply the end of the stick to the center
immature metaplasm, menopause or inflammatory of the biopsied zone for a few seconds. This cauterizes
processess has a lower glucogen content, presenting the tissue, acquiring a white color, and contact to the
areas of lesser or disperse uptake that are badly surrounding epithelium should be minimal.
defined. Dysplastic epithelium and cancer have no • Adverse effects: they present no secondary effects
glucogen, and therefore, when the lugol solution is except in the case of excessive use which produces a
applied, it acquires a mustard yellow or golden yellow dark gray color in the cervix.
azafran color. Neither do zones of leucoplasia or
hyperkeratosis take up iodine. Condylomas may not Monsel’s solution. Leon Monsel described the solution
become stained or staining may be variable. given his name in 1856 as a potent hemostatic agent. At
• Method of use: Lugol solution is applied in the same present, Monsel’s solution is used as a topical hemostatic
way as acetic acid, using a swab by direct instillation agent in minor surgical procedures such as biopsies in
or pulverization. In this case, it is not necessary to wait gynecology, proctology, dermatology, otorhinolaryngology
since the staining effect is very rapid, but it may be and odontology. In a recent study it was reported that
necessary to continue with the staining to obtain an compared to “wait and see”, the application of Monsel’s
homogeneous color. solution showed a significant reduction in bleeding at 6
• Adverse effects: this solution does not normally hours after cervical biopsy [40].
produce adverse effects, although in some cases • Composition: ferric subsulfate (15 g), ferrous sulfate
it produces mild irritation with itchiness which powder, sterile water for mixing (10 ml) and glycerol
spontaneously ceases. However, some sensitive starch (12 g). In addition to the solution there are two
patients may present an allergic reaction to iodine. other pharmaceutical forms of therapeutic utility in
paste and gel form, with the same pharmacological
properties as the solution. The semisolid forms are
more easily applied on the target tissues, and it has
been shown that they have many more irritating
21
AEPCC-Guías
characteristics than the solution [37]. The expiration Reuse of material implies carrying out the following
period is 6 months. procedures: decontamination, cleaning and sterilization or
• Mechanism of action: solutions with iron salts for high grade disinfection.
topical use have astringent and hemostatic properties. • Decontamination: this is a series of measures
The action is due to the ferric ion which is a potent adapted to ensure that the use of a medical
protein precipitant [41]. instrument is safe due to a reduction in contamination
• Method of use: a cotton swab with the solution is by microorganisms. This process can inactivate the
gently pressed onto the bleeding surface for several hepatitis B virus and HIV. After use, the instrument is
seconds to avoid the hemostatic scab falling on placed in a plastic recipient with chlorine solution at
withdrawal of the swab. It should be applied after 0.5% for 10 minutes.
completing the biopsy because it may interfere with • Cleaning: this process is crucial to ensure that the
the interpretation of the histological result [42]. instruments are safe and aseptic. Energetic manual
• Adverse effects: no relevant adverse effects have cleaning with water and liquid soap or detergent
been described. eliminates biological material such as blood, fluids
and tissue residue. If biological residue remains
present, this converts the instruments into a reservoir
4.6 MAINTENANCE OF COLPOSCOPY of germs.
MATERIAL • Sterilization: This consists in destroying all the
microorganisms present on the instrument by
Maintenance of the colposcopic equipment and sterilization exposure to physical or chemical agents. This process
of the instruments are two fundamental processes for eliminates all microbial life forms, including bacterial
achieving both optimum perfomance in the study of the lower spores. The sterilization process is fundamental to
genital tract and to guarantee safety in the transmission of safely reuse instruments in clinical settings. Two
infections among patients. sterilization methods are described:
• Sterilization by high pressure saturated steam
After use of the colposcope, it should be adequately cleaned (Autoclave): this is done by placing uncovered
and covered in order to avoid the accumulation of dust in instruments into an autoclave for at least 20 minutes
the lens. The lens should be cleaned with specific material at a temperature between 121-132°C.
for this use. Avoid the use of paper or gauzes which may • Chemical sterilization: this consists in submerging
scratch the lens. The fiber optic cables should be protected the instruments in a solution of glutaraldehyde at 2-4
against bumps, torsions or folding to impede rupture of the % for 20 minutes or in formol at 8% for 24 hours. This is
fiberglass. an alternative to steam sterilization. It requires special
manipulation with gloves. Instruments sterilized by
With use, biopsy forceps may become blunt or the glutaraldehyde or formol should be rinsed with sterile
articulation which opens or closes the forceps may harden, water prior to use since these chemical products
especially if sterilized in the autoclave on metal trays and leave residue on the instruments. In general, steam
they are not packaged prior to sterilization. Biopsy forceps sterilization is preferred over chemical sterilization
which have become blunt obtain tissue samples with more because, among other reasons, glutaraldehyde is
artefacts due to tissue crushing and produce more pain, very expensive and formol is very irritating to the skin,
and therefore, it is important to maintain these forceps in lungs and eyes.
good state and to periodically sharpen them. • Decontamination of consultation surfaces.
The auxillary tables, colposcope, electrosurgical
Disinfection/sterilization of the instruments used is an equipment, vapor aspirators, lamps, etc. should be
essential process to ensure that these are free of infectious decontaminated after each procedure using a chlorine
agents and may be safely reused in diagnostic and surgical solution at 0.5%, ethylic alcohol or isopropyl at 60-
processes [43]. 90% or other chemical disinfectants such as iodine
fluorides.
22
5. Nomenclature and description of colposcopic

findings
5.1 TERMINOLOGY effects of the same based on review of the data published in
the literature [44]. The most notable changes included in the
As mentioned in previous sections, colposcopy is a last ASCCP classification compared to that by the IFCPC
structured and orderly examination of the cervix which are the following: 1) the concept of adequate or inadequate
has the objective of interpreting colposcopic findings and the types of TZ have been replaced by a description
(colposcopic impression) and direct the biopsy to obtain as to whether the cervix can or cannot be visualized and
histological confirmation of a determined lesion. the reason for non visualization. 2) it should be reported
whether the squamocolumnar junction can or cannot be
To do this, it is very important for the nomenclature to completely visualized without discussing the types of TZ.
be uniform for good reproducibiity. For this objective, The reason for this is that the concept of type 2 TZ is little
it is fundamental to have a terminology developed by reproducible and is of scarce interest in the management
the consensus of professionals and scientific societies of the lesion. 3) replacement of the nomenclature “grade 1
involved in colposcopy. Along history multiple colposcopic or 2” changes by low or high grade changes, since these
classifications have been used and modified according to terms are better correlated with cytological and histological
the new knowledge acquired. terminology. The principal differences between the IFCPC
and ASCCP terminology are shown in table 5.2.
At present, 2 colposcopic classifications are the most

commonly used in health care practice: the classification Table 5.3 shows the different colposcopic classifications
proposed by the International Federation of Cervical over time and the most relevant changes made.
Pathology and Colposcopy (IFCPC) [1] (Table 5.1) and the

classification of the American Society for Colposcopy and The present guidelines have adopted the terminology of the
Cervical Pathology (ASCCP) [44]. IFCPC (Rio de Janeiro 2011) [1] which, in additon to being
the most commonly used, this terminology was achieved by
The classification proposed by the IFCPC [1] is the most consensus and is the “official” terminology in Europe.
internationally accepted.The last update of this classification

was carried out by a committee made up of 13 colposcopists
Recommendation: The colposcopic terminology
who are representatives of different scientific societies
that should be used in clinical practice is that of the
around the world and was presented in Río de Janeiro in
IFCPC 2011 Classification.
2011 (Table 5.1). With respect to the previous classification,
the principal novelties of the new classification are:
1. The concept of adequate examination (replacing the
classical concept of satisfactory colposcopy).
5.2 ACCURACY OF COLPOSCOPIC
2. The description of the lesions in relation to size, localization
DIAGNOSIS
and location with respect to the transformation zone.
3. Two new signs have been included in the section on
The main objective of the colposcopic terminology is
grade 2 changes (inner border sign and the ridge sign).
to obtain the best correlation between the colposcopic
4. The classification and terminology for vaginal lesions
changes described and the histological lesion. Globally,
has been included.
colposcopy is a more or less subjective and operator-
In 2016, the ASCCP constituted a working group (WG1) to
dependent evaluation technique and thereby presents
review and update the colposcopic terminology of the IFCPC
a poor interobserver correlation even among expert
as well as analyze the benefits and potential unwanted
evaluators. In addition, colposcopy is a dynamic technique
23
AEPCC-Guías
and loses validity when interpreting static images. suggesting that the grade of concordance depends on the
skill and experience of the colposcopist [35]. The grade of
The highest degree of concordance is achieved in the concordance is greater in high grade lesions or when the
interpretation of acetowhite images with a kappa index epithelium is normal and is very low in cases of low grade
of 0.37, 95%CI (0.30-0.45) [49]. However, if only the lesions [51, 52]
acetowhite changes are assessed, the correlation is lower
than if the evaluation of the border of the lesion and the The technology used for colposcopic evaluation is
vascular pattern are included [50]. considered to be a factor with considerable repercussion. At
present, high definition colposcopic equipment can obtain
Some studies have reported a good correlation of the high quality images providing greater diagnostic accuracy.
colposcopic classification with the histology of the lesion Some recent studies using last generation colposcopes
[51] while other studies have found a poor correlation, have obtained a very good correlation between the
Table 5.1: Colposcopic classification of the International Federation of Cervical Pathology and Colposcopy (IFCPC) 2011 [1]
Colposcopy terminology of the cervix of the IFCPC 20111
• Adequate/ inadequate due to... (i.e.j: cervix not clear due to

inflammation, bleeding, scarring).
• Visibility of the squamocolumnar junction completely, partially
General Evaluation
or not visible.
Types of transformation zone 1,2,3
Original squamous epithelium:

• Mature
• Atrophic
Columnar epithelium
Normal colposcopic findings • Ectopy
Metaplastic squamous epithelium
• Naboth cysts
• Glandular openings and/or glandular crypts
Deciduosis in pregnancy
Location of the lesion: inside or outside the transformation zone,

Abnormal colposcopic clockwise location of the lesion.
General principles
findings Lesion size Number of quadrants of the cervix covering the lesion,
size of the lesion as percentage of cervix.
Thin acetowhite epithelium. Fine mosaic,

Grade 1 (Minor)
Irregular border Fine pointed
Dense acetowhite
Thick mosaic,
epithelium.
Thick pointed
Rapid appearance of
Grade 2 (Major) Delimited borders
acetowhite epithelium.
Sign of the inner border limit
Open glandular orifices with
Ridge sign
thickened edges
Leukoplasia (keratosis, hyperkeratosis), Erosion

Not specific
Lugol solution (Schiller test): positive/negative
Atypical vessels
Suspicion of invasion Additional signs: thin vessels, irregular surface, exophytic lesion,
necrosis, ulceration (necrotic), nodular tumoration.
Congenital transformation Stenosis,

zone, condyloma, polyp Congenital abnormality,
Miscellaneous finding
(exocervical/ Post-treatment abnormality,
endocervical) Inflammation Endometriosis
24
Table 5.2. Differences between the ASCCP 2017 and the IFPC 2011 terminology [44]
ASCCP 2017 IFCPC 2011
General impression: visibility of the

Totally /Not totally visible Adequate/Inadequate
cervix
General impression: visibility of the Completely/Partially/Not

Totalmente /No totalmente visible
squmocolumnar junction visible
General impression: type of TZ Not used Type 1,2 or 3 TZ.
Low grade changes/ Grade 1 (minor)

Abnormal colposcopic findings
High grade changes Grade 2 (major)
Type of excision Not considered Excision type 1, 2 or 3
Table 5.3. Terminology used in the different classifications over time
Author/ Year Normal findings Abnormal findings Other terms
Mosaic leukoplasia
Hinselmann 1933 [35] Thick leukoplasia Cervicouterine ectopy
mosaico
Grade I, not suspicious, Grade II, suspicious white,

White semitransparent opaque epithelium with very Transformation zone
Coppleson 1960 [45]
epithelium, flat, with indistinct suspicious defined Grade III (TZ)
borders borders
Colposcopy not
IFCP Graz 1975 [46] Normal colposcopy Atypical TZ satisfactory.
Miscellaneous
Category 1, benign, Category 2, intermediate 4 criteria: Border, color,

Reid 1985 Puntaje [45]
Minor dysplasia Category 3, suspicious vessels, iodine uptake
Normal colposcopy Abnormal colposcopy inside

Miscellaneous not
IFCP Roma 1990 [47] Cylindrical epithelium: or outside the TZ. Mosaic/
acetowhite
ectopy Fine pointed/coarse
Minor/major changes.
IFCP Barcelona 2002 Colposcopy suggestive
Type 1, 2, 3 TZ. Suggestive of high/Low grade
[48] of invasive cancer
lesion
Grade 1 changes.
IFCP Rio de Janeiro Includes metaplasia and Includes description of
Grade 2 changes. Lesion
2011 [1] deciduosis vaginal lesions.
location.
Quadrants occupied Incorporates types of

New signs excision
Localization and size of the Miscellaneous: polyp,

Includes ectopy, Naboth cysts,
lesion. Low/high inflammation,
ASCCP 2017 [44] glandular crypts,
grades/invasive changes. congenital TZ,
metaplasia and deciduosis
New signs Post-treatment
25
AEPCC-Guías
colposcopic classification and the biopsy results (kappa are referred to colposcopy to confirm the presence of a
45.8% vs.74.1%) [53]. lesion and orient the management approach to treatment
or follow-up.
With regard to the colposcopic signs included by the IFCPC
in the last classification, one study which evaluated lesion The main advantages of colposcopy in the evaluation of the
size, in addition to the 4 variables of the Reid index, obtained risk of lesions ≥ HSIL/CIN2 are:
an increase in the specificity but at the expense of lower 1. Colposcopy can can detect premalignant lesions of
sensitivity [54]. Along the same line, another retrospective the lower genital tract.
study in 335 patients showed an elevated specificity and 2. Colposcopy can determine the most adequate biopsy
postive predictive value for the diagnosis of lesions ≥ HSIL/ site.
CIN2 for the inner border sign, the rag sign and the ridge 3. Colposcopy can facilitate and individualize treatments.
sign [55]. 4. Colposcopy allows the follow-up of intraepithelial
lesions which may be treated or followed without
Another comparative study of 525 colposcopies reviewed treatment. At present, in young women with small-
by 13 experienced colposcopists showed a good correlation sized lesions ≥ HSIL/CIN2, conservative management
with the high grade lesions using the IFCPC 2011 is accepted. Colposcopy is a key element in the follow-
classification, with a sensitivity and specificity of 63.64% up of these lesions [57].
and 96.01%, respectively. They also found 2 signs to have
predictive value: the inner border sign and the ridge sign, It was recently proposed to include the impression of the
with less agreement for defining the TZ [56]. colposcopic results with those of the screening test to
standardize the risk of lesion [58]. This suggestion should
not be confounded with the use of colposcopy as the first
Recommendation:
step in screening. Colposcopy is not recommended for
• The principal objective of colposcopy terminology
routine gynecological evaluation of women since this
is to obtain the best correlation between the col-
indication has not shown any benefit in the early diagnosis
poscopic findings and the histologic lesion.
of HSIL lesions [57].
• Acetowhite changes have a greater grade of co-
rrelation, and this increases with evaluation of the
Colposcopy before “see and treat”. The option of see
vascular pattern and the borders of the lesion.
and treat should be exceptional and reserved for patients
• •Some recently introduced colposcopic signs (in-
in whom follow-up is not possible and colposcopy results
ner border sign, ridge sign and the rag sign) have
show grade 2 changes. As advantages, colposcopy avoids
an elevated specificity and postive predictive va-
underestimation of the biopsy and reduces patient anxiety.
lue for lesions ≥ HSIL/CIN2
However, the most important risk is the elevated percentage
of conizations with a negative histology [57].
Intraoperative colposcopy. This procedure can reduce

5.3 BENEFITS OF COLPOSCOPY treatment is specific cases with possible spontaneous
regression.
Historically, before colposcopy became a part of secondary
CC prevention programs, most women with cytological
alterations underwent conization or hysterectomy with Recommendation:
the consequent associated morbidity [44]. At present, • The use of colposcopy shows greater benefits in
colposcopy is a fundamental technique in screening the detection of lesions (guides biopsy and allows
programs. histological confirmation).
• Conization should be performed under colposco-
The results of screening tests condition the risk of carrying pic control.
a lesion ≥ HSIL/CIN2. According to the level of risk, women
26
5.4 POTENTIAL HARMFUL EFFECTS • Colposcopy performed by unexperienced
OF COLPOSCOPY professionals. The principal harm induced is

underdiagnosis of high grade lesions or cancer. False
As an examination technique, colposcopy does not negative results in colposcopy are very related to the
present any contraindications. It may be used in patients experience of the professionals and the number of
with cervicitis and may even contribute to the diagnosis biopsies performed [44]. On the other hand, excessive
of this inflammatory process. Both anticoagulation and performance of biopsies and unnecessary procedures
even active bleeding are not contraindications, although may induce potential harm related to insufficient
they may induce difficulties [28]. The risks and morbidity professional training.
associated with colposcopy are considered to be very low • Anaphylactic reaction to lugol solution.
(table 5.4) [44]. The main drawbacks of colposcopy can be Isolated cases have been described including
summarized as follows: clinical manifestations of pruritis, vaginal edema,
• Pain. Colposcopy is not considered to be a painful hypotension, tachycardia and breathing difficulties.
examination, and therefore, the administration The symptomatology usually remits upon withdrawal
of analgesic drugs are not necessary prior to the of the saline lugol solution [64].
procedure. In a review of 19 randomized studies,

there were no differences in the grade of pain among
Recommendation:
patients who received oral analgesics versus those
• The principal harmful effects of colposcopy repor-
who received placebo [59].
ted by patients are pain and anxiety.
• Anxiety. The grade of anxiety during colposcopy
• Underdiagnosis or an excess number of unjusti-
(which may cause greater perception of pain and
fied biopsies are the potential harmful effects as-
discomfort) and the possible benefit of strategies
sociated with colposcopy procedures performed
to reduce this sensation have been analyzed [60].
by unexperienced professionals.
There is sufficient scientific evidence to demonstrate
the negative psychological effects women present
when they are informed of an abnormal result of the
cervical study and the associated need to perform
more tests. One recent study confirmed the negative
psychological impact of colposcopy, although the
results could not determine the factors which might
predict this impact [61]. Effective information and
communication are crucial to reduce patient anxiety.
In addition, some studies have described a reduction
in anxiety with the use of music or demonstrating the
colposcopic images during the examination. However,
a recent prospective study including 225 colposcopists
concluded that the use of videocolposcopy does
not reduce either anxiety or pain [62]. The utility of
informative pamphlets seems evident in the reduction
of the grade of sexual dysfunction which some
women present in association with having undergone
colposcopy [60].
• Inadequate use of colposcopy. As mentioned in the
previous section, colposcopy has not shown to be an
effective technique for primary screening of CC, and
therefore, it should not be used for this indication [63].
27
AEPCC-Guías
Table 5.4. Potential harmful effects of colposcopy
Adverse effects Result Evidence Treatment
No pain compared with

Pain Mild-Moderate NO
placebo
Videocolposcopy does not seem

Anxiety Produces anxiety Mild-Moderate
effective. Music may reduce anxiety.
Unnecessary
Inadequate use of the Follow guidelines and precise
procedures, over Not applicable
technique indications.
treatment.
Risk of underdiagnosis The formation of specialized units

Scarce experience of
of HSIL histological Mild and expert colposcopists reduces
the professional
lesions or cancer. the risk of underdiagnosis.
Others, anaphylaxia to
Isolated case Not applicable Elimination of lugol
lugol solution
28
6. Standards of quality in colposcopic diagnosis

6.1 REGISTRY OF THE CLINICAL • Vacunación contra el VPH (incluyendo fecha de
HISTORY OF PATIENTS REFERRED vacunación y tipo de vacuna)
TO COLPOSCOPY
Recommendation: On the first visit anamnesis
6.1.1 Anamnesis (pathological,
should be exhaustive and include patient history
gynecological and obstetric history)
(parity, HIV/immunosuppression), hormonal
situation, contraception and data on premalignant
Anamnesis prior to colposcopy should be exhaustive and
disease (HPV vaccination, date and result of
include the general medical/surgical history as well as
screening tests, history of SIL and previous
the gynecological and obstetric history of the patient and
treatments).
specific history related to diseases of the lower genital tract
(cytologies, HPV tests, colposcopies and treatments) [65].
6.1.2 Indications for performing

Questions related to the history of sexual relations may colposcopy
be embarrassing and stressful to some women, being
an aspect which may have negative repercussion on the The exact indication to perform a colposcopy and the result
sincerity and quality of the responses [66]. Therefore, it of the screening tests (cytology/HPV test) that have led to
would be better to avoid questions about sexual relations at this study should be reported in the clinical history of all
the beginning of the consultation and wait until the patient cases [2, 65].
feels more comfortable and a climate of trust has been
achieved. The fundamental objective of colposcopy is secondary
prevention of CC. To fulfil this objective there are different
Likewise, women consulting for a colposcopy may be indications for performing a colposcopy:
uncomfortable in the presence of persons other than the
physician and may need to be accompanied by someone 1. Initial study after an abnormal cytology result/HPV test.
they trust. The consultation should not include more persons 2. Follow-up of patients with intraepithelial lesion before
than strictly necessary. or after treatment. It is therefore essential to know the
indication for performing the colposcopy and the results
Quality anamnesis should include [65]: of the tests leading to this indication. Knowledge of
• Smoking habit.
previous screening results (cytology/HPV test) improves
• Date of last period (rule out pregnancy if in doubt).
the sensitivity of the colposcopic impression for high
• HIV
grade lesions [2].
• Any type of immunosuppression.
• Parity
• Current hormonal situation: fertile age/pregnancy/
Recommendation: prior to performing a colposcopy
menopause.
it is essential to know the indication and the results
• Current contraception.
of the screening tests.
• History of hysterectomy or previous treatments for
intraepithelial lesions.
• History of SIL (cervical, vaginal, vulvar or anal).
6.1.3. Verbal information and informed
• Date and result of all the previous screening tests and
consent
biopsies available.
• Vaccination against HPV (including vaccination date
All patients should receive verbal information prior to
and type of vaccine).
colposcopy and this should always be registered in the
29
AEPCC-Guías
clinical history of the patient. In addition, it is recommended the cervix and/or vagina is not injured, thereby
to give the patient a document (Annex 1) describing the avoiding the appearance of any lesion which could
characteristics of colposcopy and to which the patient additionally hinder the examination. In special cases
authorizes and agrees to undergo the procedure. In this a gynecological lubricant can be used to facilitate
case, informed consent (Annex 2) should be included in the maneuverability.
clinical history. • Using saline solution, carefully clean any secretions
making visualization of the cervix and the vagina
According to recommendations, other scientific societies difficult. If overlapping of the vaginal walls is present,
have indicated the importance of informed consent. The retract the wall using vaginal side-wall retractors, and
National Health Service (NHS) states that to achieve if these are not available, apply a condom or glove
minimal quality 95% of the women should receive verbal finger with both ends open onto the blades of the
information prior to colposcopy speculum as indiated in section 4.2. If the cervix is
[2]. The American Society for Colposcopy and Cervical in a position making observation difficult, attempt to
Pathology (ASCCP) correct this by the placement of gauze packing at the
considers informed consent to be a basic element that must end of the vaginal pouch.
be obtained before all colposcopy procedures [65]. • Visualize the vaginal-cervical anatomy, muscosal
trophism and the presence or absence of signs of
infection with white light and low magnification (x4).
Recommendation: prior to colposcopy women
• Examine the vascular pattern with the green filter.
should receive verbal information regarding the
The vessels should be observed at low light and great
characteristics of the procedure and ideally informed
magnification. Do not apply acetic acid or collect any
consent should be obtained.
sample before performing the vascular evaluation.
• Obtain samples if indicated.
• Apply acetic acid to the cervix at 3.5% either directly
(gauze or cotton swabs) or using a pulverizing device
6.2 COLPOSCOPIC EXAMINATION as indicated in section 4.3 of the guidelines. Avoid
excessive rubbing or knocking the cervix in order not
6.2.1 Cervical examination to produce unnecessary erosions or hemorrhages.

• With white light and low and high magnification
The cervical examination by colposcopy should follow a
carefully visualize the changes produced.
systematic method [67, 68]:
• Determine if colposcopy is adequate or not.
• Revise the instruments to be used.
• Identify the squamocolumnar junction and categorize
• Place the patient in a dorsal lithotomy position and
the transformation zone.
cover the patient to make her feel more comfortable.
• Identify and evaluate the characteristics of the
• Sit comfortably beside the colposcope.
colposcopic findings at the level of the cervix,
• Turn on the colposcope and adapt the interpupillary
endocervix and vaginal pouch fundus.
distance and focus the lens to the personal
• Make digitalized images whenever possible to include
characteristics of the examiner.
in the clinical history of the patient.
• Visualize the vulva and the perianal area with
• Apply lugol solution in the same way as acetic acid to
white light and at a magnification (x4) and on the
specify the topography and extension of a suspicious
appearance of any abnormality immediately perform
zone. Before the procedure ensure that the patient is
a specific study or postpone this study until the end of
not allergic to iodine.
the cervical examination.
• Make targeted biopsies in indicated cases and
• Introduce a speculum of adequate size and length
coagulate bleeding zones of the area biopsied.
into the vagina. It is important to move the speculum
• Carefully withdraw the speculum. If the women
carefully, avoiding brusque movements which
reports significant stinging after the examination due
might produce pain to the patient and ensure that
to transitory dehydration produced by the solutions
30
used, a vaginal moisturizer may be applied before

withdrawal of the speculum. Recommendation: colposcopic evaluation of the
• Revise the samples to ensure correct identification vagina should be systematically performed and
before sending them for analysis. may be facilitated using low magnification and lugol
solution.
Recommendation: colposcopic examinations

should always be performed following a systematic 6.2.3 Examination of the vulva
method.
Colposcopic examination of the vulva (vulvoscopy) can
identify subclinical lesions not observed in the general
6.2.2 Examination of the vagina examination and helps to define the extension of the
disease and guide biopsy [70].
Vaginal examination by colposcopy (vaginoscopy) is
a technical challenge for a colposcopist and a more Examination under low magnification is used for the general
uncomfortable and lengthy process for patients. The surface evaluation of the vulva and greater magnification is used for
examined is much greater than in the cervix. The vaginal in depth examination of small lesions.
mucous presents a large quantity of rough areas or folds It is important to take the following aspects into account in
and the blades of the speculum do not allow visualization vulvar examinations [71]:
of 360º at one time, making it necessary to repeat the • Acetic acid solution should be of 5%, and you should
application of the fluids used (acetic acid and lugol) and wait between 3 to 5 minutes in order for it to be effective
rotations of the speculum. in the areas of the keratinized epithelium [72].
• Whitening of determined areas after applying the
The general principals and methodology are similar to those acetic acid presents a low specificity since the
described in the case of colposcopy. Of note are a series of vulvar epithelium, mainly at the level of the introitus,
specific nuances [67]: frequently reacts diffusely to acetic acid in the absence
• The patient is placed in a dorsal lithotomy position, but
of disease.
the examination can be facilitated by raising the buttocks
• Abnormal vascular patterns can be observed as
5-10 degrees.
pointed and mosaic, although there is no analogy
• The size of the speculum should have sufficient depth
between the colposcopic changes described in the
to observe the distal vagina but should also allow easy
cervix and those found in the vulva.
rotation.
• It is preferable to use acetic acid at 5%, since this solution
more rapidly demonstrates the presence of lesions (if
Recommendation: colposcopic evaluation of the
present).
vulva can be performed using low magnification and
• Since the effect of lugol solution does not disappear
acetic acid soluton at 5%.
over time, the use of this solution is especially important
because it can detect small lesions which may not have
been observed in the examination with acetic acid.
• Strict order should be followed in order to ensure that no
zone remains unexamined [69]. The examination begins 6.3 REPORTING AND REGISTRY OF
in the fundus of the vaginal pouch by lateral mobilization COLPOSCOPIC FINDINGS
of the cervix with a gauze or spatula. In patients who
have previously undergone hysterectomy, a hook, 6.3.1 Description of colposcopic findings
endocervical speculum or polyp forceps may be useful
to reach these angles. Then, the middle and outer thirds The description of the colposcopic findings is a medical
of the vagina are examined, and afterwards, with careful document which facilitates the follow-up of patients,
rotation of the speculum, the anterior and posterior walls
orientation of clinical approaches following diagnosis and
of the vagina are evaluated.
31
AEPCC-Guías
the evaluation of discordant results. For all these reasons, negative repercussions. An observational study in patients
this description should be meticulous and exhaustive. At with HSIL cytology reported that the probability of finding
present, the description of an examination constitutes one carcinoma lesions is related to the absolute size of the
of the most relevant indicators of quality of Lower Genital lesion and the percentage of the TZ affected [78]. These
Tract Disease Units [65]. data are a practical demonstration of the importance of
reporting the information of the characteristics of the lesion
Evaluation of the cervix and the squamocolumnar junction. in all colposcopies [29].
The recommendations of the principal scientific societies
of lower genital tract disease and colposcopy coincide in Lastly, complete or incomplete visualization of the lesion
that adequate or inadequate visualization of the cervix, the may condition the clinical approach or the efficacy of the
squamocolumnar junction and the description of the type of treatment. The current clinical guidelines accept that
TZ (1, 2, 3), according to the IFCPC classification criteria this information should be registered in at least 70-100%
[1] is an important indicator of quality. Their importance of the colposcopies performed [2, 29, 73]. However, a
mainly lies in that the diagnostic/therapeutic management systematic review showed that the presence of infiltrating
of determined cytological alterations is conditioned by these lesions is more frequent when the upper limit of the lesion
indicators. cannot be visualized because of being introduced into the
endocervical canal (61% of microinvasion, 71% of invasive
The description and registry of the visualization of the disease). This demonstrates the importance of reporting all
cervix (adequate or inadequate) should be made in 100% the information which may be relevant in the treatment and
of the colposcopies carried out (minimum required 70%) [2, follow-up of the patient.
73].The description and registry of the squamocolumnar
junction and the type of TZ should be made in 100% of the
Recommendation: description of the colposcopic
colposcopies (minimum required 70%) [29, 74-76].
findings should be strict and exhaustive.
Evaluation of the lesion (type of lesion, size, localization,

visibility, semiology).
6.3.2 Registry of colposcopic data and
Evaluation of the lesion is a fundamental aspect for
images (diagrams, photos)
establishing an adequate correlation between the different
Registry of the colposcopic images (ideally with
diagnostic tests (cytology, HPV test, colposcopy) and the
colpophotographies or if not available, with diagrams or
provisional and/or definitive histological study. A lack of
schemas) should be done in 100% of the cases (minimun
documentation may lead to over/underestimation of the
required 70%).
results of these tests and colposcopic impression.
These images and schemas should be included with the

colposcopy report and be available among the printed materials
The description and registry of the characteristics of the
available when necessary. It is recommendable to include them
lesion (type of lesion, localization in the cervix, complete
in the electronic clinical history of the patients [65].
or incomplete visibility and semiology) should be made in
all the cases (minimum required 90%) [77] according to the
Iconographic registry of the colposcopic findings
IFCPC nomenclature [1].
(colpophotography) and representation in graphic schemas
is an essential part of the work to be carried out by
Knowledge of the localization of the lesion in the cervix and
colposcopists. In addition, it can evaluate the correlation
its size are fundamental for planning the most adequate
of the results (cytology and/or HPV test, histology and
clinical approach (treatment or follow-up). The lack of
colposcopic impression) of the lesions, and monitor and
documentation of these aspects may lead to inappropriate
assess the follow-up of treated patients and of lesions not
clinical actions, and in the case of surgical treatment,
candidates for treatment.
insufficient or excessive resections, with the subsequent
32
In general lines, colposcopy-guided biopsy is recommended

Recommendation: registry of colposcopic images in cases with cytology findings ≥ HSIL and whenever an
is essential (preferably with colpophotographies in abnormal TZis observed. Pregnancy is an exception [2].
the electronic history). Another option is to register
the colposcopic findings as schemas or diagrams. Colposcopy-guided biopsy consists in obtaining one or
several samples of the abnormal cervical epithelium.
This procedures does not require the administration of
6.3.3 Reporting of colposcopic anesthesia [83]. It is usually carried out with punch forceps.
impression The use of small diathermic loops is also possible and may
improve the quality and quantity of tissue resected without
The colposcopic impression should be reported in 100% of increasing the pain to the patient during sample taking [84,
the colposcopies (minimum required 80%) [29, 73, 75, 76]. 85]. The order for sample taking should be from back to
front to avoid bleeding, which would hinder visualization of
Reporting of the colposcopic impression should also be the remaining areas to be biopsied, and preferably of the
made taking into account the IFCPC classification [1]. area closest to the TZ(centripetal localization) since this is
This parameter is related to the quality of the colposcopic where the higher grade lesions are usually found. In the
prediction and has the objective of achieving a high positive case of lesions suspected of invasion, avoid taking the
predictive value of findings classified as grade 2 for the samples from the zones showing necrosis. For the cervical
histological diagnosis of lesions ≥ HSIL/CIN2. biopsy to be representative of the sample it must contain
epithelial and stroma tissue. The percentage of adequate
In most cases, colposcopic findings classified as grade 2 biopsies for histological diagnosis should be greater than
changes should be correlated with a histological diagnosis 90% [2].
of ≥HSIL/CIN2 (>75%) [79].
The efficacy of the colposcopy to detect SIL/CIN and

invasive lesions is largely conditioned by the experience
Recommendation: on completing the colposcopic
of the colposcopists and their capacity to interpret the
examination the colposcopic impression should be
coloposcopic findings and adequately target the biopsies
reported according to IFCPC terminology in all the
to the zones in which the colposcopic impression suggests
cases.
greater lesional grade.
Among expert colposcopists there is little interobserver

variability in characterizing normal epithelium with grade 2
6.4 COLPOSCOPY-GUIDED BIOPSY
changes (suggestive of lesions ≥ HSIL/CIN2) or with lesions
suggestive of invasion. This variability increases in the case
6.4.1 Adequacy of the biopsies
of grade 1 changes (suggestive of LSIL/CIN 1), although
the definitive diagnosis of these entities is achieved by the
In most cases, the detection of an abnormal cervical
histological study [51].
screening test implies the need to perform colposcopy
and colposcopy-guided biopsy. Colposcopy shows the
The selection of the most significant lesional area to perform
architectonic pattern of the epithelium and classifies each
the directed biopsy is conditioned by the subjectivity of
image as abnormal according to the alterations presented
the colposcopic impression. A metaanalysis including 32
(grade 1 and grade 2 changes or changes suggestive of
studies with close to 8000 biopsies evaluated the diagnostic
carcinoma) according to the characteristics defined in the
yield of the colposcopic impression. After biopsy, all the
classification of the International Federation for Cervical
patients underwent excisional therapy, and the histological
Pathology and Colposcopy (IFCPC)
diagnosis was considered the gold standard. The sensitivity
[1]. Directed biopsy obtains a confirmatory histological diagnosis
and specificity of the colposcopy to detect HSIL/CIN2
and orients the most adequate treatment planning [82].
lesions in the conization piece differed according to whether
33
AEPCC-Guías
the result of the directed biopsy was LSIL/CIN 1 (91%

and 25%, respectively) or ≥ HSIL/CIN2 (81% and 63%, Recommendation:
respectively) [86]. • Cervical biopsy should always be guided by
colposcopy. The sample should be selected
Retrospective studies have shown that compared to from areas showing greatest abnormality and
excisional histological diagnosis, directed biopsy may should contain adequate representation of
both “overestimate” the grade of the lesion when it is small the epithelium and the stroma (percentage of
since the biopsy has divided the fragment with the greatest satisfactory biopsies greater than 90%).
abnormality, and more often, it may “underestimate” the • Selection of the most significant epithelial area
severity of the lesion (4.3% and 57.1% in HSIL/CIN2 to perform the directed biopsy should take the
lesions) [2]. colposcopic impression into account.
Although colposcopy is a fundamental examination in the

secondary prevention of CC, it continues to be a subjective 6.4.2 Number of biopsies
and operator-dependent technique, and therefore, the
reproducibility of the colposcopic impression and the Traditionally, it has been recommended to take a single
directed biopsy is limited, and the sensitivity and specificity biopsy sample selected from the colposcopic area
for the diagnosis of lesions ≥ HSIL/CIN2 is lower than what presenting the greatest abnormality. Recent studies have
has classically been reported. The most important factors shown that correct diagnosis is not achieved with a single
contributing to this limitation are: biopsy in up to 40% of precursor lesions. An increase in
• Lack of standardization in colposcopic terminology. the number of biopsies is translated into an increase in the
• Lack of consensus recommendations on how to sensitivity of colposcopy to detect lesions ≥ HSIL/CIN2 [58].
perform a colposcopic examination.
• Lack of reliable and measurable measures of quality
control. Data from the National Cancer Institute Biopsy Study
• Use of colposcopy in the hands of non expert demonstrate that performing a second or third biopsy in
professionals. areas with small colposcopic alterations of the TZincreases
the sensitivity to detect precancerous lesions from 61% to
Other factors which may contribute to over or under 86% or 96%, respectively [88]. Thus, the objective is to find
diagnosis of a lesion ≥ HSIL/CIN2 are: a balance between achieving greater sensitivity to detect
• Patient age. precursor lesions and adjusting the number of biopsies in
• Menopausal status. order to avoid unnecessary procedures in the colposcopic
• Visibility of the squamocolumnar junction. examination. Although the characteristics of the lesions
• Size of the lesion. and the risk of the patient presenting lesions ≥ HSIL/CIN2
• Endocervical extension. should be evaluated, in general, it is recommended to
• Number of biopsies performed [58, 87]. perform directed biopsies mapping the different abnormal
colposcopic areas (generally between 1 to 4 biopsies
according to the extension and complexity of the lesion).
34
2) Perform direct biopsies if there is high risk of ≥ HSIL/

Recommendation: CIN2 lesions. This recommendation is applicable in women
• Taking a single directed biopsy of the colpos- over the age of 25 years, who are not pregnant and who
copic area with the greatest abnormality has a have at least two of the following criteria:
lower sensitivity for the detection of lesions ≥ • HSIL cytology.
HSIL/CIN2 than multiple biopsies. • Infection by HPV16 or 18.
• Based on the characteristics of the lesion and • Colposcopic impression with grade 2 changes.
the risk of lesions ≥ HSIL/CIN2, it is recommen- If multiple biopsies are made and are negative, strict
ded to perform directed biopsies of the different control should be performed according to the norms of the
abnormal colposcopic areas. prevailing clinical guidelines. Data from the National Cancer
Institute Biopsy Study demonstrate that if multiple biopsies
are negative, the negative predictive value (NPV) (that is,
6.4.3 Cervical biopsy sampling according the probabiity of absence of a lesion ≥ HSIL/CIN2) is high
to level of risk [88].
In cases with an abnormal screening test, the ASCCP [58] 3) Immediate excisional treatment in the presence of
recommends adapting the colposcopy and biopsy sampling high risk of ≥ HSIL/CIN2. This recommendation may be
based on the level of risk of ≥ HSIL/CIN2. acceptable in selected cases and implies fulfulling the same
criteria as in the point above.
This risk mainly depends on:
• The cytology results. The results of a systematic review on the see and treat
• The presence of infection by HPV genotypes 16/18. strategy showed that 89% of women with HSIL based on
• Colposcopic impression. cytology have a lesion ≥ HSIL/CIN2 in the excisional piece.
This percentage is greater if the colposcopic impression is
The combination of these markers can stratify the population of grade 2 changes or the HPV test is positive for HPV types
into high and low risk of underlying ≥ HSIL/CIN2. Based on 16 or 18 for which immediate treatment is acceptable.
this evaluation of risk the ASCCP recommends:
1) Not to perform biopsies if there is a low risk of ≥HSIL/

CIN2. This recommendation is applicable in women fulfilling
all of the following criteria:
• Cytology showing minor alterations (<HSIL).
• HPV other than 16/18.
• Colposcopic impression without acetowhite areas of
metaplasia or other visible abnormalities.
Many studies have shown that there is a very low risk

of ≥HSIL/CIN2 in women classified as having low risk.
A prospective study carried out in the United Kingdom
reported that the probability of detecting a precursor
lesion in the successive years is very low [89]. To the
contrary, biopsy sampling is recommended even when
the colposcopic impression does not suggest a significant
lesion (acetowhite areas compatible with metaplasia or
another minor abnormality), since not performing a biopsy
increases the risk of underdiagnosing ≥HSIL/CIN2 lesions.
35
AEPCC-Guías
Recommendation: Recommendation:
• Directed biopsy sampling should take into • Non directed biopsy sampling (within the trans-
account the level of risk of lesions ≥ HSIL/ formation zone) can be carried out in cases
CIN2 which depends on the cytology results, in which the colposcopic impression does not
the presence of HPV16/18 and the colposcopic show evidence of a lesion and there is a risk of
impression.
lesions ≥ HSIL/CIN2.
• Do not perform biopsies in women with low risk
• Non direct biopsy sampling should never be
of lesions ≥ HSIL/CIN2: cytology < HSIL, no
performed in cases with a low risk of lesions ≥
HPV 16/18 and normal colposcopic impres-
HSIL/CIN2.
sion.
• Perform multiple biopsies in women over 25
years of age, not pregnant, with high risk of le-
sions ≥ HSIL/CIN2 and at least 2 factors: HSIL
6.4.5 Endocervical study(biopsy with
cytology, HPV 16 or 18, colposcopic impres-
curettage or cytological smear)
sion with grade 2 changes.
• Perform immediate excisional treatment if there Histological evaluation of the endocervical canal is an
is a high risk of lesions ≥ HSIL/CIN2, and this integral part of the study in women with an abnormal
can be performed in selected cases fulfilling screening test result. However, the role of endocervical
the criteria mentioned in the previous point. biopsy is controversial due to the discomfort and pain
produced in patients, and moreover, it has limitations in
relation to sample quality, sensitivity and false positive and
6.4.4 Non directed biopsies negative results.

The term “non directed biopsy” applies to cervical biopsies The procedure consists in introducing a curette into the
which are randomly taken from inside the transformaton cervical canal (fenestrated Novak cannula or fenestrated
zone, despite having a normal colposcopic impression kevorkian curette) and debride the four quadrants to
(without acetowhite areas or with ≤ grade 1 alterations obtain strips of epithelium which are representative of all
suggesting SIL/CIN). Some studies highlight the value of the endocervical surface. The sample should be sent for
non directed biopsies when there is a risk of lesions ≥ HSIL/ histological study separately from the other cervical samples
CIN2 [58]. since it is important to register the endocervical location of
the lesions. On occasions, the endocervical sample may
Many studies have shown that non directed biopsies of the contain cells of the ectocervix in which a positive result
TZwith a normal colposcopic impression is not effective in may lead to overtreatment. This most frequently occurs in
cases with a low risk of lesions ≥ HSIL/CIN2 (cytology < cases in which the TZis in the endocervical canal such as
HSIL and HPV 16 or 18 infection) [90]. in the case of menopausal women or in those who have
previously undergone excisional therapy.
This stratification of risk can thereby adapt the colposcopy
procedure to each case. At the end of this stratification we An endocervical biopsy is considered inadequate when
can either not perform a biopsy in cases with a low risk of there is a lack of sufficient evaluable tissue. This is reported
lesions ≥ HSIL/CIN2, or to the contrary, perform immediate in up to 20% of cases. An inadequate biopsy should not be
treatment without previous biopsy in cases in which the risk interpreted as a negative result, and therefore, if the result
is elevated. In the remaining intermediate cases, taking affects the approach to be followed, then the possibility of
multiple biopsy samples when the colposcopic results are obtaining a new sample should be considered. This decision
normal (with no clear evidence of grade 1 or 2 lesions) or should be individualized since there are cases, especially in
when there are minimal acetowhite areas seems to be of menopause, in which it is practically impossible to obtain
value since this can increase the detection of high grade adequate histological material. Endocervical study is
precursor lesions. indicated when the colposcopic lesion shows an endocervical
36
component.The results of an endocervical biopsy can lead

to the diagnosis of 5-15% of patients with lesions ≥ HSIL/ Recommendation:
CIN2. Therefore, this procedure increases the diagnostic • Endocervical study with curettage or brushing
sensitivity fundamentally in menopausal women. In addition, should be performed when the colposcopic le-
it can obtain samples of non continguous lesions which are sion shows an endocervical component (more
a characteristic feature of glandular lesions, and therefore, frequent in menopause or post-treatment).
on suspicion of a possible glandular lesion an endocervical • Endocervical study immediately after conization
study should always be performed [91]. Endocervical biopsy is indicated since it has an elevated predictive
carried out immediately before treatment has shown a low value of lesional persistence.
sensitivity for detecting glandular alterations (false negative • Endocervical curettage is contraindicated du-
rate of 59-78%) [92]. ring pregnancy.
It is also recommended to perform an endocervical biopsy

immediately after conization. A post-treatment endocervical
study is, moreover, a better predictive factor of lesional 6.5 REPORTING AND REGISTRY OF
persistence affecting the margins, despite some series BIOPSIES
describing false negative rates of 58-67% [2, 92].
6.5.1 Localization, number of biopsies
Endocervical curettage is contraindicated during pregnancy and characteristics of the areas selected
[82]. for biopsy.
In the last years, the limitations of biopsy or endocervical It is fundamental to correctly report and register the number
curettage have favored evaluation of the role of cytological of biopsies performed, their exact localization in the cervix
smears or endocervical brushing. According to data in and the colposcopic characteristics of the areas selected
the literature, endocervical brushing shows a sensitivity for biopsy. This information contributes to determining the
of 77-93% versus 36-64% for endocervical curettage, most adequate clinical approach to take. Description of the
although the specificity of the former is lower (26-38%), localization can be performed based on the four quadrants
with a percentage of false positive results of 28-75% due to of the cervix or according to a clockwise distribution. To do
probable contamination of the samples with cells from the this, diagrams or graphic schemas should be used with a
exocervix [93, 94]. registry format that depends on the institution in which the
sample taking is performed [91].
One randomized clinical trial evaluated the role of
endocervical brushing and endocervical curettage In the case of multiple biopsies, these should be identified
associated with colposcopy-guided biopsy. The sensitivity separately according to the localization in the cervix and
of the direct biopsy was 96% with a specificity of 95%. When fixed in formal at room temperature for posterior histological
direct biopsy was associated with endocervical curettage, analysis, the report of which should include [84]:
the values were 82% y 88%, respectively [95]. • Sample size (mm).
• Type of tissue.
One additional advantage reported for endocervical • Sample quality.
brushing is the low percentage of inadequate samples • Absence or presence of lesion.
due to lack of tissue (approximately 2%) compared to • Lesional grade and/or type of lesion.
20% for endocervical curettage [95]. Together with greater • Presence of changes associated with HPV infection
tolerability of endocervical brushing and a lower cost, these (koilocytes, dyskeratosis).
data justify the utiity of this technique in the study of the • Characterization of non neoplastic lesions.
endocervical canal versus endocervical curettage, although • Stromal reaction (presence and extension of
a positive result should be interpreted with caution to avoid inflammatory or desmoplastic reaction)
overtreatment [96]. • In the case of invasion, depth and lateral extension,
37
AEPCC-Guías
presentation of lymphovascular involvement and between the physician and the patient. The transmission
grade of differenciation. of adequate information and having the patient participate
in decision making has shown a reduction in anxiety
throughout the process, thereby favoring compliance and
Recommendation:
follow-up [2].
• It is essential to correctly report and register all
cervical biopsies (number, localization and col-
The patient should be given written material of the verbally
poscopic characteristics).
transmitted information (for example, using support material
such as http://www.aepcc.org/pacientes/) which can help to
clarify doubts arising after the medical visit and reduce the
6.5.2 Endocervical study (biopsy with
need to search for additional information at sources of non
curettage or cytological smear
contrasted quality. When the results of the screening tests
have been integrated with the colposcopic and histological
Reporting of the endocervical biopsy is analogous to that
findings, the therapeutic strategy should be planned as
of exocervical biopsies. In this case the endocervical
well as the most adequate follow-up in each case. This
biopsy with curettage is a single sample that should contain
information should be registered in the clinical history and
material of all the endocervical canal. Cytological brush
clearly reported to the patient in the simplest and most
smear should only contain the material obtained from the
comprehensible way and within the shortest time possible.
endocervix, avoiding, whenever possible, exocervical
contamination.
Recommendation:
6.6 Reporting of the results to the patient • Following biopsy the histological report should
and follow-up be available within a period of less than 4 wee-
ks.
The patient should receive verbal and written information of • The patient should receive verbal and written
the results of the studies performed. The histopathological explanations of the results of the colposcopy
reports should be available within a relatively short period and the complementary studies performed.
of time after biopsy. Delay in the diagnosis may have
repercussions in relation to a delay in the treatment of
potentially invasive lesions and patient anxiety [73].
The negative psychological impact which an abnormal

screening test result has in women and the consequent
colposcopic evaluation requires adequate communication
38
7. Colposcopy units. Standards of quality and

recommendations.
7.1 STANDARDS OF QUALITY OF A 7.1.1 Coordination and management of

COLPOSCOPY UNIT the Colposcopy Unit.
Colposcopy Units should have clinical protocols which Colposcopy Units should be coordinated or directed by a
follow the national guidelines. These protocols should be professional with great experience in this area.
accessible and open and submitted to periodic updating. In
addition, standards of quality should be documented and Unit coordinator: Colposcopy teams should have a
periodic controls should be carried out to evaluate their coordinator. The coordinator should be the person of
fulfillment. reference of the team and should supervise the correct
functioning of the unit, ensuring fulfillment of good practice
Ideally, the members of the unit team should be accredited and standards of quality as well as the follow-up and
for their activity and continuing education should periodically updating of the protocols. It is recommended that the
be made. coordinator be a colposcopist with wide experience and
is accredited in colposcopy. The coordinator should be
It is essential for a Colposcopy Unit to have an established involved, moreover, in the definition of the criteria of patient
circuit of reporting of any error, difficulty or need (table 7.1 referral to the Colposcopy Unit and should have a direct
shows a list of fundamental points which should make up relationship with the team colposcopists, the pathologists
the standards of quality of Colposcopy Units)[2, 74, 97]. and the other professionals who work in the unit.
Table 7.1: Standards of quality in Colposcopy Units. Head of the Department: Depending on the size of the
unit and structure of the work center, both figures (Unit
Coordinator and Head of Department) should be assumed
• Good practice guidelines. by the same person. If this is not so, there should be fluid
• Equipment. periodic communication between the two. The Head of the
• Diagnostic strategy. Department is responsible for ensuring the execution of the
• Maximum referral times after abnormal cytology. patient referral circuits to the unit.
• Referral criteria for colposcopies different from
abnormal cytology. 7.1.2 Quality control of the Colposcopy
• Test in colposcopy. Unit
• Procedure protocols.
• Informed consent for the procedures. Quality control of the activities carried out in the Colposcopy
• Organization with assignment of functionas of the Unit should periodically be performed.
members.
• Multidisciplinary work. Ideally, an annual audit of the indicators of quality specified
• Training and accreditation of the colposcopists. in the present guideliens should be carried out. All the team
• Databases. should know the results of the audit and make a joint analysis
• Definition of standards by processes. of the results. This audit can be made by members of the
• Standards for colposcopy. AEPCC-Guidelines Colposcopy Unit but other pathologists
• Reduce patient anxiety. and midwives from primary care responsible for screening
• Follow-up of patients who do not attend visits. can also intervene.
Quality control of a Colposcopy Unit is not possible without
39
AEPCC-Guías
detailed colleciton of the data of health care activity of the 6. Percentage of treatments carried out with each therapeutic
unit. It is fundamental to have a systematic data collection modality (diathermic loop, excision or laser vaporization,
system which faciltates evaluation of the activity of the unit cryotherapy, follow-up without treatment, etc.).
in order to perform adequate quality control.
Recommendation: The type of treatment carried

The indicators which can be audited in a Colposcopy Unit out should be registered in all the cases.
are shown below:
1. Number of positive directed biopsies by each colposcopist 7. Number of conizations with a histological diagnosis of a
and altogether. lesion ≥ HSIL/CIN2.
Recommendation: the percentage of positive Recommendation: Lesions ≥ HSIL/CIN2 should

directed biopsies for lesions should be ≥ 80%). be confirmed in ≥ 70% of the conization pieces.
2. The level of concordance between the diagnostic 8. Number of cone biopsies without histological lesions
impression of the colposcopy and the result of the biopsy. All (blank cones).
the units should obtain annual data of sensitivity, specificity,
positive predictive value (PPV) and negative predictive
Recommendation: The percentage of conizations
value (NPV) together and separately for abnormal grade 1
with histological lesions should be ≤15%.
and 2 colposcopic findings.
Recommendation: Globally, in the diagnosis of a 9. Percentage of conziations with affected margins.

lesion colposcopy should have a sensitivity ≥ 80% The number of margins affected in each case and their
and a specificity ≥ 70% localization (exocervical, endocervical or deep) should be
specified.
3. Number of conizations annually.

Recommendation: The percentage of conizations
with lesion-positive margins should be ≤ 20% (≤
Recommendation: The number of conizations 15% of endocervial margins).
performed each year should be registered.
10. Percentage of cases treated of HSIL/CIN with cytology

4. Number of conziations performed in the outpatient setting ≥ HSIL/CIN2 at 6 and 24 months after treatment.
(in the consulting office and with local anesthesia).
Recommendation: The percentage of cytologies≥

Recommendation: the percentage of conizations HSIL/CIN2 at 6 months should be ≤10% and ≤5% at
performed in the outpatient setting should be ≥ 70%. 24 months.
5. Percentage of conizations performed under colposcopic 11. Fulfillment of waiting times from diagnosis to colposcopy.
control.
Recommendation: The percentage of fulfillment of

Recommendation: the percentage of conizations recommended waiting times should be ≥ 90%.
performed under colposcopic control should be ≥ 90%.
40
12. Fulfillment of administration of the vaccine against HPV homogeneous criteria of quality and a grade of fulfillment
post-conization in communities in which the vaccine is to ensure excellence in the care given to patients in
funded. colposcopy. Table 7.2 shows the European standards
of quality established by the European Federation of
Recommendation: The percentage of meeting the Colposcopy in Paris in 2017.
HPV vaccine schedule in women after conization

(according to the protocols of each autonomous
7.1.3 Information and communication
community this percentage should be ≥ 90%.
with the patient
Communication with the patient is key in the perception of

13. Registry of claims or complaints by patients. quality of a Pathology Unit of the Lower Genital Tract. There
is evidence of the negative psychological repercussion
which informing a patient of an abnormal cytology result or
Recommendation: Register the number of claims
an HPV test has on the patient. Clear, adequate information
and complaints annually and analyze the reasons
notably reduces the level of anxiety and favors posterior
for them.
treatment and follow-up.
14. Number of sessions in the Colposcopy Unit and Before screening tests and coloposcopy, all women should
interdisciplinary sessons established in the unit. receive verbal/written information of the objectives of these
studies. They should also be given verbal/written information
of the results of these tests and of the colposcopy. Likewise,
Recommendation: Register the annual number of
all women with abnormal results should receive written
unit and interdisciplinary sessions carried out.
information about the clinical approach to be followed. The
time from these tests to obtaining the results should be as
short as possible.
At present, there is great concern about establishing
Table 7.2. European Standards of Quality - Paris - 2017
Parameter %
The type of TZ (1,2,3) should be reported in colposcopy. 100%
Percentage of cases with colposcopy prior to treatment due to abnormal cytology results. 100%
Percentage of women with definitive histological diagnosis of ≥ HSIL/CIN2 in biopsies or

85%
excisional treatments.
Percentage of excisional or conization lesions which are border-free. > 80%
Number of low grade colposcopies (individual) performed per year after abnormal screening
> 50
cytology results.
Number of high grade colposcopies (individual) performed per year after abnormal screening
> 50
cytology results.
41
AEPCC-Guías
The results of the tests and the follow-up policy should be

reported to the general practitioner. Recommendation: Colposcopy Units should
coordinate and achieve consensus regarding the
flow of patients referred from screening programs
Recommendation: based on regional or national guidelines.
• Patients should be correctly informed (prefera-
bly in writing) of the objective of the screening
tests and the possiblity of complementary stu-
dies (≥ 90%) and of the results of screening 7.2 PERSONNEL, INSTALLATIONS
tests and colposcopy(≥ 90%). AND EQUIPMENT IN THE
• The results should be reported to the patient wi- COLPOSCOPY UNIT
thin a maximum of 8 weeks.
7.2.1 Staffing
7.1.4 Certification The personnel adscribed to a Colposcopy Unit should have

experience in pathology of the lower genital tract.
All colposcopists should have a training program or should
have received specific training to achieve accreditation in
Medical personnel:
colposcopy. All training programs should fulfill national and
The number of professionals is based on the work volume
European standards.
of the Colposcopy Unit, and these personnel should know
the national screening and clinical approaches in depth as
well as all the treatment techniques.
Recommendation: The members of a Colposcopy
Unit should be accredited (ideally ≥ 50%) .
Staffing of a Colposcopy Unit should be able to assume the
waiting times established in the standards of quality of the
7.1.5 Coordination with screening present guidelines in the case of abnormal screening tests,
programs the performance of treatment and visits for results and
follow-up of their process.
The coordinator of the Colposcopy Unit or the Head of Ideally, the personnel of the Colposcopy Unit should have
Department should have consensus with the levels of sufficient time available to correctly provide the care and
primary care in relation to the flow of patients referred carry out internal controls of quality, team meetings, and
according to the screening framework recommended in internal and multidisciplinary sessions. It is also important to
national and/or local guidelines. have time for pregraduate and postgraduate teaching and
continuing education.
Consensus regarding referral circuits should be established
for each of the diseases which can be referred to the Nursing personnel:
Colposcopy Unit. The circuits established should be Nursing personnel in the Colposcopy Unit should be
accessible and available for consultation and review. qualified and have specific training and experience in
the support and clinical approaches in women consulting
At a national level, the clinical approach to follow in patients for suspicion of a preneoplastic lesions or cancer and its
undergoing CC screening should be performed according treatment. These personnel should be integrated into the
to the published clinical guidelines (APECC-Guidelines on team and actively participate in the unit. This participation
Screening and AEPCC-Guidelines on Prevention available should include their attendance to internal meetings,
at: http://www. knowledge of the standards of quality and commitment to
aepcc.org/aepcc-guias/) [27, 33] following the referral correct functioning of the unit.
circuits established with the primary care centers.
In the case of having more than one nurse, one nurse
42
should be responsible for nursing in the unit. Continuing

7.3 Equipment in the Colposcopy Unit for diagnosis
educaiton should be ensured among all the nursing staff
by colposcopy.
related to the unit.
1. Colposcope with magnification (different ranges

The responsibilities of the nursing staff of the Lower Genital
from 23 to 24), filters.
Tract Unit are:
a. Exterior screen.
• Control of fungible and non fungible material.
b. Camara for photos and videocolposcopy.
• Control of material for treatment in the consulting
c. Image archiving system.
office.
d. System for colposcopy report with photos
• Collection of data of cytological smears and biopsies
incorporated.
of the patient consulting.
2. Types of spatulas and cytobrush for liquid based
• Identification of samples and sending of the samples
cytology medium..
to central services.
3. Adequate liquid medium diagnostic vials.
• They may be in charge of user satisfaction surveys.
4. Saline solution.
5. Acetic acid at 5%
Recommendation: 6. Cotton swabs for use of acetic acid.
• The medical personnel of the Colposcopy 7. Lugol solution.
Unit should be experienced and staffing and 8. Cotton swabs for application of lugol solution.
organization should ensure correct care, quality 9. Speculums of different sizes.
control, teaching and continuing education. 10. Speculums for evaluaton of the endocervix.
• Nursing personnel should be qualified and 11. Forceps for selective biopsy.
integrated into the functioning of the unit. 12. Novak and/or Cornier cannulas and/or curette or
cytobrush for endocervical sampling.
13. Vials with formol duly accredited for each patient.
7.2.2 Installations and equipment 14. Monsel’s solution or silver nitrate sticks for
cauterization of post-biopsy bleeding.
Colposcopy Units should fulfill all the health care 15. Hemostratic gauzes.
requirements of safety and access to first aid. They 16. Punch forceps of different sizes.
should be correctly equipped for the diagnosis, treatment,
collection and storage of clinical data and images. They
should also have an area dedicated to management and for
administrative personnel. 7.4 Equipment of the Colposcopy Unit for outpatient
conization.
All the equipment should be regularly revised to guarantee

correct functionality at all times. The privacy of the consulting 1. Non conductive speculums with smoke aspiration
office and especially the place where the colposcopic system.
examination is performed should be ensured and at least 2. Smoke aspiration system.
one accompanying person should be allowed to be present, 3. Electrosurgical current system including cutting
if the patient wishes. and coagulation.
4. Dispersive plate for closing the electrical circuit.
5. Local anesthesia plus vasoconstrictor.
6. 25-27 gauge needles for the application of
Recommendation: The installations and equipment anesthesia.
of the Colposcopy Units should fulfill the health care 7. Diathermic loops of different sizes.
requirements of safety, equipment and privacy. 8. 3 or 5 mm ball electrodes for coagulation.
43
AEPCC-Guías
7.3. Organization and administrative designing common protocols, establishing agreements for
management patient referral and to coordinate diagnostic and therapeutic
procedures as well as joint evaluation in complex cases.
As in any working group the Colposcopy Unit should have a
work organigram showing the functions and responsibilities
Recommendation:
of each member of the team and to ensure the availabiity
• Specialists in the Colposcopy Unit should
of adequate material resources in order for each member of
periodically meet (preferably every 1 or 2
the team to adequately carry out their work.
weeks).
• Multidisciplinary meetings with specialists
The Colposcopy Unit requires administrative support
related to the Colposcopy Unit should be held
which is essential for: 1) facilitating communication and
every trimester.
appointment making with patients, 2) managing the
relationship with other departments of the center,
and 3) collaborate in data collection.
7.4 CLINICAL DOCUMENTATION

Each medical consultation should include a specialized
nurse.
All the activity of the Colposcopy Unit should be documented
in a standardized format. All the documentation and data
Recommendation: The organization of the of the patients should follow the legal requirements of data
Colposcopy Unit requires a specific organigram protection.
and administrative support as well as specialized

nursing personnel. All the documents which professionals should collect, store
or provide to the patient are described below.
1. Clinical history of the patient. This should include:
7.3.1 Organization and meetings • Personal history, including allergies, toxic habits,
of the Colposcopy Unit and with diseases, usual treatments, immunodepressive
multidisciplinary teams. treatments, HIV status, diseases involving
immunosuppression.
The team of a Colposcopy Unit should periodically meet • Gynecological history, including parity (abortions,
for the presentation of clinical cases and review of relevant miscarriages, deliveries, type of delivery, age at first
clinical aspects or therapeutic indications. delivery), menarchy, menogram and date of last period,
menopause, local hormone treatment, systemic
The meetings of the unit are especially useful for: hormone replacement treatment, contraception (type,
• Raising questions of team logistics. length of contraception, contraception in the last 6
• Presenting the results of the audits of standards of months), sexual activity (age at first coitus, number
quality and evaluate options for improvement. of sexual partners), HPV vaccine status, previous
• Discuss projects for improving specific aspects of the treatments of the cervix, vagina and vulva, previous
unit. screening (last cytology, result, history of SIL).
• Present and discuss investigation projects and their • Reason for consultation for the current episode.
results. • Physical examination including the report of the
• Periodically review the unit protocols. colposcopy examination, if biopsies have or have not
been performed as well as the number and localization
In addition, it is recommended to establish periodic of the biopsies.
multidisciplinary meetings with related departments
(pathologists, dermatologists, internal medicine physicians, 2. Informed consent. Required for each procedure.
hematologists...). These meetings are essential for • Colposcopy (Annex 2).
44
• Cervical treatments: conization, cryotherapy, ablative 7. Informative documents for the patients. This type of
or excisional treatments with CO2 laser. informative document or pamphlet should describe the
• Treatments of the vulva or vagina: incisional or most frequent processes related to diseases of the lower
excisional procedures, ablative treatments with genital tract and HPV infection (conization, HPV infection,
cryotherapy or CO2 laser. vaccination for HPV, vulvar and vaginal disease, etc.).
Informed consent is obtained according to the prevailing

legal requirements. In cases of electronic clinical data 7.5 COLPOSCOPY TRAINING,
systems, it is recommended to scan the consent forms and CERTIFICATION AND CONTINUING
include them with the documents of the clinical history of MEDICAL EDUCATION.
the patient.
7.5.1 Training and certification of
3. Indication of follow-up. After each visit the patient should colposcopists.
receive clear information as to when a new visit should be
made and how to structure the follow-up. Ideally, the patient In all Colposcopy Units at least 50% of the colposcopists
should leave with the visit and the specific appointment should be accredited in colposcopy by the AEPCC.
programmed for the next control.
All colposcopists should have minimum experience,
4. Images and archiving of the colposcopic images. which, according to the European standards of quality
Colposcopic examination of the lower genital tract may (Paris 2017), includes:
be documented by colpophotographies or videos. These • Number of low grade colposcopies (individual)
images constitute very valuable information of the clinical performed at one year after an abnormal screening
history and ideally should be archived or included in the cytology result (> 50).
electronic clinical history. In the general consent or specific • Number of high grade colposcopies (individual)
consent form the patient should expressly authorize the performed after an abnormal screening cytology
capture and storage of these images. result (>50).
5. Discharge report after treatment. After any treatment, 7.5.2 Content of the training and
especially if this is excisional, a discharge report should be evaluation.
provided which specifies the procedure performed as well
as the recommendations that the patient should follow in the Colposcopy training involves some minimum requirements
days after the intervention and the alarm signs which could [98-100].
lead to consultation to the reference unit. This information
should be provided in written form in order to contribute to Minimum general training required in colposcopy
the safety of the patient, reduce patient anxiety and favor • Understand the development of cervical neoplasia.
adherence to the indications. • Ensure that the colposcopy procedure complies with
the recommendations of health and safety.
6. Discharge from the Colposcopy Unit. Document to be • Treat patients according to the criteria of national
given to the patient which should include: guidelines.
• Reason for consultation. • Provide adequate information prior to the colposcopy.
• Results of the studies performed. • Answer questions related to management of the
• Treatments performed. lesion.
• Evolution and follow-up. • Communicate with other health care professionals.
• Reason for discharge. • Understand the national screening guidelines.
• Specific follow-up schedule to be carried out with the • Be able to carefully report the results.
reference gynecologist and/or primary care physician • Provide data to the national health care system.
in the patient’s health care center.
45
AEPCC-Guías
Basic examination: minimum requirements. anxiety and facilitate follow-up prior to performing
• Be able to write the clinical history. colposcopy.
• Examine the vagina. • The woman should receive verbal and written
• Examine the vulva. information prior to colposcopy.
• Place and adjust the colposcope. • Advice should be integrated in the care.
• Be able to place the patient in the position to perform • Communication of the results of tests and treatment
the colposcopy. plans should be informed directly to the patient, and
• Be able to insert the vaginal speculum. this information should always be provided in writing.
• Use the endocervical speculum. • There should be a professional who is responsible
• Report the colposcopic findings. for standards of quality and to monitor the same at
• Provide adequate information after the colposcopy. least annually.
• The audit of the results should be global and
Colposcopic procedure. personalized.
• Perform cervical sampling. • The nurses of the unit should be qualified and have
• Perform bacteriological smears. experience in the support and management of
• Examine the TZwith transparent and green filters. suspicion of preneoplastic lesions or cancer and their
• Examine the TZwith acetic acid. treatment.
• Perform the Schiller test.
• Describe the changes with acetic acid and the 7.5.3 Maintenance of clinical skills and
Schiller test. continuing medical education (CME)
• If indicated, perform biopsies (cervix, vagina and
vulva). All the members of the Colposcopy Unit should perform a
sufficient number of cases annually to maintain their clinical
Documentation of the colposcopy skills as stated in the standards of quality of these Clinical
• Make the colposcopy report using the IFCPC Guidelines.
nomenclature.
• Produce report with the diagnosis and indications of Continuing medical education is the responsibility of each
follow-up and/or treatment. member of the team as well as the unit. Periodical updating
of the references and review of the protocols in the unit
Therapeutic procedures should be made in addition to attendance to local, national
• Perform excisional treatments with local anesthesia. and international congresses.
• Perform excisional treatments with general
anesthesia. Sessions of bibliographic review and updating should be
• Perform ablative treatments with cryotherapy. promoted within the unit.
Electrocoagulation, CO2 laser (if this equipment is
available in the unit).
Patient communication skills

• The result of an abnormal cytology produces patient
anxiety, and therefore, education on the transmission
of information should be promoted to reduce patient
46
8. Infections, cytology and colposcopy

In addition to detecting premalignant lesions of the cervix 8.2 APPROACH TO INFECTIONS
(fundamental objective), cervical cytology and colposcopy FOUND IN CYTOLOGY CITOLOGÍA
can also detect infectious agents or changes suggestive of
determined infections. However, their diagnostic yield for Although it is not the primary objective, the accuracy of the
this objective is very low, and they should therefore not be diagnosis of these infections varies among the different
exclusively used for the diagnosis of infections of the lower microorganisms in question [101].
genital tract.
The most frequent infections described in cytology reports

are shown below, although their description in the current
8.1 SAMPLE COLLECTION FOR terminology of the Berthesda system is not obligatory.
THE STUDY OF INFECTIONS IN THE
COLPOSCOPY CONSULTATION. 8.2.1 Actinomyces
This aim of this section is not to describe the treatment Cytological examinations have a low sensitivity, specificity
and most adequate clinical approach to each infection. and positive predictive value for the detection of actinomyces.
In fact, it is not indicated to use the CC screening vist for
taking samples for the screening of some frequent genital Infection by actinomyces is detected in 7% of women
infections such as chlamydia or gonorrhea. using an interuterine device (IUD) and is very infrequent
in women without an IUD. Women carrying actinomyces
This statement is justified based on the fact that gonococcal are usually asymptomatic. After cytological detection the
infection, and especially, infection by chlamydia are very significance of the prognosis is very low in the absence of
frequent in very young women (during the first years of specific symptoms [2].
sexual life). For this reason, the screening of these infections
is recommended in women under the age of 25. In women with a cytological diagnosis of actinomyces who
are completely asymptomatic, treatment or IUD extraction is
On the other hand, CC screening is indicated above the age not indicated [102]. To the contrary, in symptomatic women,
of 25 years, when the incidence of these infections is lower the IUD should be extracted and specific follow-up should
[10]. There is no evidence supporting the screening of these be made to ensure the resolution of the infection. In these
infections or showing cost-effectiveness in women over the cases it should be ensured that the patient uses adequate
age of 25 [2]. contraception to avoid the risk of unwanted pregnancy [2].
However, since conventional cervical cytology or

liquid-based cytology medium can identify determined Recommendation: Cytological detection of acti-
microorganisms, this section schematically covers the nomyces has a low sensitivity, specificity and PPV.
approach to these findings in the cytological reports. In asymptomatic women it is not necessary to ex-
tract the IUD or administer specific treatments.
Recommendation: It is not justified to use the CC

screening visit to perform the screening of infections 8.2.2 Tricomonas vaginalis
of the lower genital tract.
Tricomoniasis is the most frequent, non viral, sexually
transmitted disease (STD). Although some patients with this
infection present cervicitis, leukorrhea and signs of vulvar
irritation, most (70-85%) have minimum symptomatology
47
AEPCC-Guías
[103]. Therefore, a significant number of women without

symptoms or who do not present any evident cervicitis Recommendation: Cytological detection of candida
may be diagnosed with this infection by cytology. However, is frequent, although this method is considered
to have a low sensitivity. This finding is not an
microscopic study of fresh tissue presents a sensitivity
indication for treatment in asymptomatic patients.
of approximately 50% to detect infection by tricomona
Other associated infections should be ruled out.
vaginalis [104].
In cases with cytological results showing infection by 8.2.4 Bacterial vaginosis

tricomonas vaginalis, treatment is indicated in both the
patient and her partner. Bacterial vaginosis is the replacement of the normal vaginal
flora constituted by Lactobacillus spp. by anaerobic bacteria
such as Prevotella spp. or Mobiluncus spp. It is considered
Recommendation: Cytological detection of
tricomonas vaginalis may occur in patients who are to be a polymicrobial infection and is the most prevalent
asymptomatic or without signs of cervicitis. In all the vaginal infection among women of reproductive age in
cases, treatment should be indicated in both the developed countries [105]. It is one of the most frequent
patient and her partner. causes of malodorous leukorrhea, although an elevated
percentage of women with bacterial vaginosis present
scarce symptoms or are asymptomatic.
8.2.3 Candida species
The presence of clue cells or cervical-vaginal cells covered
Vulvovaginitis by candida is very frequent, with approximately by coccobacilli adhered to their surface and associated
70-80% of women presenting at least one episode along with a reduction or absence of lactobacilli is a characteristic
their lives, and more than 40% present several episodes. cytological sign associated with bacterial vaginosis.
Asymptomatic conization for candida or for other fungal However, the presence of these cells alone is not diagnostic
species is also very frequent (10-20% are asymptomatic of infection.
carriers)[104]. Therefore, it is relatively frequent for cervical
cytology to report the presence of candida. Nonetheless, The diagnosis of bacterial vaginosis is based on the
cytology is considered to be a scarcely sensitive method presence of clinical (Amsel criteria) or cytomorphologic
among diagnostic procedures to detect candida species. criteria (Gram staining), and in some cases, even requires
confirmation by biochemical criteria.
The mere presence of candida in the cytology study of
asymptomatic patients is not an indication to receive
treatment. In some cases the presence of spores is Recommendation: Cytological detection of
indicative of the reproductive activity of the microorganism, bacterial vaginosis is frequent. The presence
of characteristic clue cells is not diagnostic of
and thus, the probability of presenting symptoms and
infection. The diagnosis and treatment should be
requiring treatment.
based on clinical criteria.
In cases in which the cytological report describes the

presence of candida, the coexistence of other associated 8.2.5 Chlamydia tracomatis
infections should be ruled out.
The sensitivity of cytology for the diagnosis of chlamydia

is very low (approximately 30%). Liquid-based cytology
samples are considered adequate for the detection of
chlamydia using nucleic acid amplification testing (NAAT),
although the sensitivity may be slightly lower than that
obtained in samples of vaginal or cervical lavage.
48
The detection of chlamydia is of no interest in CC prevention sensitivity is less than 40% [101]. Therefore, with this finding
programs but may be of interest in symptomatic women or in cytology the patient should be evaluated and questioned
in those suspected of having inflammatory pelvic infection. about lesions or genital discomfort, and additional tests
should be performed such as polymerase chain reaction
(PCR).
Recommendation: Cytological detection of
chlamydia tracomatis has a very low sensitivity.
This finding is of interest in symptomatic women or Recommendation: The specificity of cytology for the
in those with pelvic inflammatory disease. Liquid- detection of findings suggestive of herpes simplex is
based cytology samples are adequate for performing high, but the sensitivity is low. Specific techniques
NAAT techniques. such as PCR are needed for confirmation. Liquid-
based cytological samples are adequate for these
techniques.
8.2.6 Neisseria gonorrhoeae
Cytology may show the presence of intracytoplasmatic

8.3 Communication of the results to the
diplococci suggestive of infection by Neisseria gonorrhoeae;
patient.
however, this procedure is not diagnostic since other
The cytology or colposcopic results of patients attended
common non pathogenic species of neisseria present
for CC screening may find alterations suggestive of or
similar findings [2]. Therefore, confirmatory tests based on
confirming genital infection. In some cases, specific
amplification methods (NAAT) are always necessary.
treatment is indicated and in others the patient should be
reevaluated with specific tests to confirm the diagnosis or
Cervical samples by liquid cytology are adequate for
refer the patient to a clinic specialized in STD.
the preservation of DNA, and thus, for the detection and
confirmation of this infection.
Communication of the results should take into account
the impact that knowledge of being a carrier of a potential
Although the detection of N. gonorrhoeae is not of interest
sexually transmitted infection may have on the patient or
in CC prevention programs, it may be indicated to perform
partner. Protocols should be established to determine
the study in liquid cytology samples in symptomatic women
in which cases the study should be amplified or in whom
with suspicion of inflammatory pelvic infection.
additional confirmatory tests should be made in both the
patient and the partner and in which cases it is possible to
Recommendation: Cytological detection of administer treatment and specific follow-up.
intracytoplasmatic diplococci is not always
diagnostic of infection by Neissereia gonorrhoeae
(always requires confirmation techinques). Liquid Recommendation:
cytology samples are adequate for performing • Cytology may suggest or confirm genital
NAAT techniques. infection. Protocols should determine in which
cases the study should be amplified or treatment
and specific follow-up should be performed in
8.2.7 Herpes Simplex Virus (HSV) both the patient and the partner.
• On communicating the presence of an STD
after the cytology results, the impact this may
Cytology may show findings suggestive of herpes simplex
have on the patient and her partner should be
virus (cells with a multinucleated appearance and peripheral taken into account.
margination of chromatin to the nuclear membrane or
ground glass appearance, and occasionally intranuclear
esoinophilic or viral inclusions are observed).
The specificity of cytology for this infection is high, but the
49
AEPCC-Guías
9. Colposcopy standards in special situations
9.1 PREGNANCY justifies a conservative approach, and therefore,

colposcopy may be deferred until 6 weeks after
Colposcopy in pregnant women should be performed delivery.
whenever there is an indication, and the main objective • Susupicion or confirmation of LSIL/CIN 1 or less:
should be to rule out invasive cancer. The great difficulty in defer the control until after delivery.
evaluating the cervix during pregnancy makes it essential for • HSIL cytology: immediate colposcopy.
the procedure to be performed by experienced professionals • On suspicion or histological confirmation of HSIL/
within a Colposcopy Unit. The cervix undergoes notable CIN2-3 trimestral colpscopic control is recommended
changes during pregnancy. On one hand, the endocervical during pregnancy, with a new evaluation postpartum.
columnar epithelium shows hypersecretion which • Positive HPV test with the presence of HPV 16 or 18
extends outward in the ectocervix facilitating vision of the genotypes: colposcopy is the preferred option [110],
squamocolumnar junction. Vascularization increases with especially if there is a concomittant abnormal cytology
certain venous stasis and edema. The stroma may also result. If the cytology is negative a conservative
show decidual changes or deciduosis which may affect small approach may be taken and colposcopy may be
isolated areas or diffusely extend throughout the cervix. All derred until 6 weeks after delivery.
of this leads to a cyanotic and edematous appearance which • Clinical or colposcopic suspicion of invasive
is characteristic of the cervix in pregnant women and which cancer: an adequate biopy is required to achieve
bleeds easily, further hindering colposcopy, especially in the a diagnosis. A biopsy that only suggests SIL/CIN
last trimester and in multiparous women. does not reliably rule out invasion. In these cases,
conization is indicated despite a risk of hemorrhage
The incidence of CC in pregnancy is low ranging, from of approximately 25%. The main objective of cervical
1-.5 to 15.6 cases per 100,000 deliveries [106, 107]. biopsy during pregnancy is to rule out an invasive
Approximately, 1 to 3% of CC are diagnosed during lesion, and therefore, it is always recommended on
pregnancy or postpartum [108]. Five percent of pregnancies cytological or colposcopic suspicion of infiltration.
may present an abnormal cervical screening result [109].

In general, and except for invasive cancer, the treatment of
For some women pregnancy may be the first opportunity for high grade cervical lesions should be deferred until 6 weeks
cervical screening. In addition, a diagnosis of CC is more after delivery and preferably before 3 months.
probable in women who have never undergone screening

tests.
Recommendation:
• Colposcopy should be performed in pregnant
The first visit during pregnancy should include a review of the
women whenever there is a precise indication,
screening history, and in the absence of a screening history,
and it should be carried out by experienced
a cervical smear should be made for HPV testing and/or
professionals in Colposcopy Units.
cytology based on the corresponding screening protocol. It
• Colposcopic evaluation during pregnancy is
must be remembered that the use of an endocervical brush
more complex due to physiological changes in
is not advised.
the cervix.
• The main objective of colposcopy in pregnancy
The indications for referring a pregnant woman for
is to rule out CC. On clinical and colposcopic
colposcopy study are:
suspicion, biopsy or even conization should be
• LSIL cytology: colposcopy is the preferential option
performed.
although not imperative. The low risk of occult
carcinoma or lesion which progresses to carcinoma
50
9.2 MENOPAUSE 9.3 USE OF CONTRACEPTIVES
Colposcopy is more difficult in menopausal women due The possible carcinogenic effect of oral contraceptives has
to the physiological changes presented in the cervix in been analyzed in numerous studies. One systematic review
relation to a deficiency of estrogen and epithelial atrophy. In of 28 studies found that, in comparison with women who
most cases, the squamocolumnar junction is not visible for never used oral contraceptives, the relative risk (RR) of
being in the interior of the cervical canal (type 3). Atrophy CC increased with an increase in the length of use of oral
and epithelial thinning easily produces bleeding and de- contraceptives. The results were similar for both squamous
epithelization which makes the colposcopy inadequate. carcinoma and adenocarcinoma. The risk decreased with
In addition, in an elevated percentage of cases, ACsUS discontinuation of the contraceptive pill [114, 115].
or LSIL cytology in menopausal women is due to atrophy
and estrogen deficit. Therefore, the application of local Although HPV is a necessary cause of CC, it has also been
estrogens during 6-8 weeks in postmenopausal women associated with other risk factors such as elevated parity
with marked atrophy and ASCUS or LSIL before repeating and the use of oral contraceptives. In a recent prospective
the cytology is an acceptable option which improves the study of a cohort of 308,036 women, the duration of use
cytological and colposcopic study [111]. of oral contraceptives during more than 15 years was
associated with a significant increase of HSIL/CIN2-3 and
Prospective studies have shown that the incidence of cancer, compared to women who had never taken them,
cervical lesions and CC is low in postmenopausal women suggesting that there are hormonal factors of risk for
with previously normal screening results. In addition, they cervical carcinogenesis [116].
confirm that hormone replacement therapy with estrogens
and progesterone has no significant effect on the positivity However, on weighing the risks and benefits, the World
of the HPV test or abnormal cytologies [112-114]. Health Organization (WHO) does not recommend any
change in the practice of oral contraceptives. Adherence
Postmenopausal bleeding is not an indication for performing to the current cervical cancer screening schedules should
preventive cervical screening regardless of whether the minimize the greater risk of cervical cancer associated with
patient has correctly followed the cervical screening these hormonal risk factors.
program or not. Since postmenopausal hemorrhage may
be the first symptom of genital cancer, the patient should
Recommendation:
immediately be referred to a gynecologist for undergoing
the pertinent diagnostic tests. Any delay in diagnosis can
• The benefits and risk of the use of contraceptives
should be evaluated individually in patients with
serverely worsen the prognosis.
premalignant cervical lesions or HPV infection.
• The WHO does not recommend any change in
Recommendation: the schedules which may represent an increase
• Colposcopy is more difficult in menopause in unwanted pregnancies.
because of the associated atrophy.
• Treatment with topical estrogens may facilitate
both evaluation of the cytological sample as
well as interpretation of colposcopy. 9.4 HYSTERECTOMY
• Postmenopausal genital hemorrhage is not
an indication for screening but rather for The approach in any patient in whom hysterectomy is
gynecological examination to rule out an indicated depends on two factors: 1) the presence of SIL/
eventual gynceological cancer. CIN at the time of the hysterectomy 2) previous screening
results.
51
AEPCC-Guías
Patients who have undergone hysterectomy for CC or the patient should be referred for vaginoscopy.
endometrial cancer should follow the pertinent gynecological
oncology protocol. Patients with subtotal hysterectomy Total hysterectomy for benign processes.
should follow cervical screening the same as the general In patients requiring hysterectomy for disease not related
population. to HPV, it is necessary to include a review of the screening
history in the preoperative study, and in the absence of
Total hysterectomy in patients with SIL/CIN. screening, an HPV test and cytology should be performed
At present, hysterectomy is not a treatment of choice [2]. Patients with a positive result should be referred to
for SIL/CIN. It is only justified if associated with benign colposcopy for evaluation prior to surgery.
disease such as myomas or prolapse or when conservative • With a normal cervical screening history (negative
treatment is not possible due to persistence of SIL/CIN. HPV test and cytology). Patients do not require to
follow the screening program.
The risk of SIL/ vaginal intraepithelial neoplasia (SIL/VaIN) • With no history of or unknown cervical screening.
after hysterectomy for SIL/CIN is 5%. A joint analysis of Perform co-test in vaginal vault. If the result is negative,
4 series with 1,149 patients controlled over 5 to 20 years futher control is not necessary. In the presence of a
detected 61 cases of SIL/VaIN (5.3%), 3 of which progressed positive HPV test and/or abnormal cytology, refer the
to cancer [117-120]. In most cases, the development of SIL/ patient to colposcopy.
VaIN post-hysterectomy is the consequence of persistence • Following treatment of HSIL/CIN2-3, with controls of
or reinfection by HPV and is rarely due to incomplete complete cure and no evidence of cervical disease,
resection of SIL/CIN [121, 122]. follow with routine screening of the vaginal vault until
completing 20 years of follow-up.
Relatively frequently SIL/VaIN develops in the epithelium
which may remain buried in the scar of the vaginal fundus
Recommendation:
and angles. This conditions a greater limitation for diagnosis,
increasing the risk of developing an occult cancer which
• Women with negative screening and
hysterectomy for disease not related to HPV
may debut as an endopelvic tumor growth [123].
should discontinue screening.
Prior to surgery a thorough colposcopy with lugol staining

• Women treated with hysterectomy for
HPV-related diseases should undergo the
should be performed to determine the status of the vaginal
correpsonding post-treatment follow-up and
vault and rule out a possible SIL/VaIN.
afterwards continue with screening for at least
20 years.
Patients with SIL/CIN treated by hysterectomy should
undergo a co-test at 16, 18 and 36 months after treatment.
In the presence of a positive HPV test and/or abnormal
cytology, the patient should be referred for a vaginoscopy
[110].
If the vaginal margin is affected with an intraepithelial

neoplasia, and the controls are negative, periodic follow-up
should be carried out. Cases of invasive neoplasia in the
vaginal vault have been described after more than 20 years.
Total hysterectomy for adenocarcinoma in situ (AIS).

Annual control of the vaginal vault should be made with
co-test for at least 20 years. At present, there are no data
supporting the discontinuation of control [110, 9]. In the
presence of a positive HPV test and/or abnormal cytology,
52
10. Colposcopy practice according to the level of risk

The principal objective of CC screening is to reduce the Women with negative cytology and HPV test have a very
incidence and mortality of this neoplasm by the detection low risk of presenting a precursor lesion in the following
and treatment of lesions with a risk of progression (HSIL/ 5 to 10 years and present virtually no risk of developing
CIN2-3). The risk of presenting or developing a HSIL/CIN2- a CC in this period. To the contrary, patients with HSIL
3 should determine the frequency and intensity of follow-up cytology, a positive HPV test (especially for genotypes 16
or the type of treatment so that similar risk carries similar or 18) and a colposcopy with grade 2 changes present an
interventions [124]. 80% probability of having a lesion ≥ HSIL/CIN3 within the
following 2 years. This information justifies clinical decision
The introduction of new diagnostic tests into clinical practice making based on the knowledge and quantification of risk
and the conjugation of new molecular, morphologic and of precancer estimated by the result and the combination
colposcopic markers has led to more precise prevention of of the different screening tests as has been described in
CC and facilitates more accurate quantification of the risk different prospective studies and clinical trials [124].
of having or developing this cancer. This information allows
the planning of strategies of clinical practice based on more Table 10.1 shows some levels of risk for HSIL/CIN3
rational use of the tests and greater optimization of the according to the cytology and HPV test results as well as
resources, which translates into more efficient screening. the clinical proposals for follow-up [124].
Estimation of the risk of HSIL/CIN2-3 or CC is the result
of the combination of the different tests performed, and Patients referred to the Colposcopy Unit for an abnormal
when the level of risk is the same, the same clinical strategy screening test have a wide range of risk of having SIL/CIN.
should be considered. This risk may be estimated by the result of the screeing test
and molecular tests together with the colposcopy images.
Along the same line, the ASCCP [58] recently proposed
10.1 DEFINITION OF RISK OF a series of recommendations based on a systematic
PREMALIGNANT CERVICAL LESION review of published evidence in which the procedures to
ACCORDING TO MOLECULAR, be performed are indicated based on the estimation of risk
MORPHOLOGIC AND COLPOSCOPIC of presenting HSIL/CIN3. This risk is evaluated from the
MARKERS. results of 3 parameters:
• Cytology result (morphological marker).
The screening of CC has classically been based on cervical • Determination of HPV with genotyping (molecular
cytology. In most cases, an abnormal cytology implies marker).
the need for colposcopy and directed biopsies with the • Initial colposcopic impression (colposcopic marker).
objective of obtaining histological confirmation. Therefore,
the histological diagnosis is considered the gold standard The combination of these markers of risk can stratify the
which largely determines the clinical approach. population into three groups of risk (table 10.2). The need
to perform biopsies is determined according to the level of
The incorporation of the test for HPV detection and risk established [58].
genotyping into clinical practice as well as other molecular
markers and their combination with morphological (cytology)
and colposcopic markers provides greater potential in the
stratification of risk of a premalignant lesion. The greater or
lesser probability of identifying a lesion ≥ HSIL/CIN2 using
these procedures can classify patients into a level of high,
low or null risk.
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AEPCC-Guías
Recommendation:
• In the case of an abnormal result of the screening
tests the markers of risk are evaluated: cytology
(morphological), HPV test (molecular) and
colposcopic impression (colposcopic). The need
for directed biopsies is established according to
the level of risk.
• Women with a low risk of lesion ≥ HSIL/CIN2 are
those who fulfill the criteria of: cytology < HSIL,
negative HPV 16/18 and normal colposcopy.
• Women with a high risk of lesions are those who
fulfill at least 2 criteria of: cytology ≥ HSIL, AGC
or ASC-H; positive HPV 16/18; colposcopy with
grade 2 changes.
• Women with intermediate risk of lesion ≥ HSIL/
CIN2 are those who are not included in the
previous 2 groups.
Table 10.1. Risk of premalignant cervical lesion based on the screening tests and tools proposed for clinical
follow-up.
Scenario of Result of Absolute risk of

Clinical proposal for precancer
screening or clinical Cytology result oncogenic HPV
follow-up CIN3a
management test
Screening Negative HPV - Routine < 2%
Screening/Triage ASCUS HPV -

Post-colposcopyb VPH -
Screening Negative HPV + 12 months 2 – < 10%

Screening LSIL HPV –
Screening Post- ASCUS
colposcopyb Negative HPV +
LLETZ
Screening /Triage ASCUS HPV + Colposcopy >10%

Screening post LSIL HPV +
colposcopyb
Post LLETZ > ASCUS HPV + Colposcopy/Treatment > 40%
Screening
Post-colposcopyb HSIL HPV + Treatment? > 40%

CIN2 biopsia Treatment
Colposcopy
HSIL VPH + Treatment? > 60%
grade 2
a. Risk until the following screening round - b. Results of cytology and HPV test in the control at 6 months after colposcopy.
[124]Reproduced from Castle PE, Sideri M, Jeronimo J, Solomon D, Schiffman M. Risk assessment to guide the prevention of cervical cáncer.
Journal of Lower Genital Tract Disease, Volume 12, Number 1, 2008, 1-7.
54
Table 10.2: Level of risk of having SIL/CIN based on cytology, HPV test and colposcopy.
Low risk High risk Intermediate risk

(Fulfill the following 3 criteria): (Fulfill at least 2 of the following (cases not included in the 2 previous
• Cytology < HSIL criteria): groups).
• Negative HPV 16/18 • Cytology ≥ HSIL, AGC or ASC-H
• Normal colposcopy • Positive HPV 16/18
• Colposcopy with grade 2 changes.
Number and type of biopy taken in colposcopy established that non directed biopsies or at random biopies
Numerous studies have demonstrated that taking a single should not be carried out in patients with a very low risk
directed biopsy in the zone with the greatest colposcopic referred to colposcopy
abnormality may not diagnose between one third to more (cytology < HSIL, HPV test not 16 or 18 and colposcopy
than half of SIL/CIN (Table 10.3). It is recommended to without grade 2 changes).
perform directed biopsies mapping the different abnormal
colposcopic areas (see section 6.4). Many studies have shown that women with cytology results
< LSIL, HPV infection by genotypes other than 16 or 18 and
normal colposcopy or with grade 1 changes have a low risk
10.2 COLPOSCOPIC PRACTICE of presenting an underlying lesion ≥ HSIL/CIN2 (Table 10.4).
IN WOMEN WITH LOW RISK OF In these cases it is recommended to perform a directed
PRECANCER biopy in the abnormal areas of acetowhite epithelium,
metaplaia or another abnormality. Not performing directed
In this regard the ASCCP [58], and based on the stratification biopsy in these situations implies a risk of underdiagnosing
of risk obtained with the markers described above, have a lesion ≥ HSIL/CIN2.
Table 10.3. Increase in the rate of detection of premalignant lesions with an

increase in the number of biopsies.
Study Population Endpoints 1 biopsy 2 biopsies 3 biopsies 4 biopsies
Multicenter
2 years 142/208 108/132 35/42
ALTS trial [87] ALTS trial, NA
≥CIN3 (68.3%) (81.8%) (83.3%)
in the USA
Cross-
Pretorious et SPOCCS, 141/122 198/222
sectional
al. [125] China (63.5%) (89%)
≥CIN3
EVAH study,
Cross-
Van der Marel The 136/263 159/263
sectional
et. al. [126] Netherlands (51.7%) (60.4%)
≥CIN2
and Spain
Wentzensen Biopsy study, Cross- 157/252 222/252 246/252 252/252

et al. [88] USA sectional (60.6%) (85.6%) (95.6%) (100%)
HSIL+
ALTS indicates ASCUS-LSIL Triage Study; NA not applicable; CIN: intraepithelial cervical neoplasia; HSIL high-grade squamous in-
traepithelial lesion.
SPOCCS, Shanx i Province Cervical Cancer Screening Study; EVAH, Evaluando la Visual Apariencia de las lesiones cervicales y su
diagnóstico histológico, genotipo del virus del papiloma humano y otros parámetros virales.
[58] Reproduced from Wentzensen N, M Schiffman, Silver MI, Khan MJ, Perkins RB, Smith KM, MD, Gage JC, Gold MA, Conageski C,
Einstein MH, Mayeaux EJ, Waxman AG, Huh WK, MD, Massad LS. ASCCP Colposcopy Standards: Risk-Based Colposcopy Practice. J
Low Genit Tract Dis 2017;21: 230–234.
55
AEPCC-Guías
Table 10.4. Risk of premalignant cervical lesion in women with a normal colposcopy
normal and previous low risk.
Study n HSIL/CIN2 HSIL/CIN3 Proportion HSIL/CIN2 Proportion HSIL/CIN3
ATHENA 660 15 6 0.0227 0.0091
ALTS trial 402 4 2 0.0100 0.0050
BD Oncoclarity 1572 25 11 0.0159 0.0070
Biopsy Study 38 3 0 0.0789 0.0000
Pool estimado 2672 47 19 0.015 0.004
10.3 COLPOSCOPY PRACTICE and reproducible. The parameters of high risk (HSIL
IN WOMEN WITH HIGH RISK OF cytology and colposcopy with grade 2 changes)
PRECANCER and those of low risk (cytology < HSIL and normal
colposcopy) are more reproducible than the
In women stratified in the high risk group [58], that is, those intermediate categories of cytology and colposcopy.
presenting at least two of the following parameters (HSIL • The estimations of risk for specific strata should be
cytology, positive HPV test for genotype 16 and/or 18 and comparable among populations. A systematic review
colposcopy with grade 2 changes), it is recommended to of the publications showed that the variability in the
immediately perform colposcopy with multiple directed evaluation of risk for different strata was low.
biopsies (preferably of all the abnormal areas). Even • The strategy must be able to be used in clinical
in selected cases it is acceptable to perform excisional practice. Dividing the population into a few strata with
treatment without a confirmatory biopsy. If in cases different levels of risk is clinicially more practical and
undergoing biopsies, these do not show a lesion ≥ HSIL/ facilitates management.
CIN2, then an endocervical study should be carried out

[30, 33, 75]. In summary, the evaluation of risk of HSIL/CIN in a
colposcopy visit can modify the procedures, adapting
A systematic review of the see and treat strategy in women them to the risk of each woman. In this way, when the
with HSIL cytology found that in 89% the excisional risk is low it is possible to observe and follow the patient
procedure confirmed the presence of a lesion ≥ HSIL/CIN2 without performing a biopsy and treat without histological
[127], while other studies reported lower values (Table confirmation when the risk is higher. For women in all the
10.5). The 2012 clinical guidelines of the ASCCP consider other risk groups, taking multiple directed biopsies including
performing immediate direct treatment in women with the areas with a minimum acetowhite epithelium is important
cytological HSIL. Table 4 shows the risk of precancer in the to improve the detection of SIL/CIN in the colposcopy visit.
different studies in women with HSIL and colposcopy with

major grade 2 changes or HPV16 positive and colposcopy At present, other biomarkerswhich may provide greater
with grade 2 changes which substantially exceed the accuracy in the evaluation of risk are under investigation
rate of risk of HSIL in whom immediate treatment can be [131], among which the following are of note:
recommended [58]. • Dual p16/Ki67 staining: Positive results for this

test are positively related to the histological grade
In order for this strategy based on the stratification of risk of the cervical lesion. Although the study results are
to be successful, it is necessary for determined conditions discordant, some have shown that dual staining is
to be met [58]: useful for the selection of HPV positive women with
• The markers of evaluation of risk must be reliable normal cytology who would present a high probability
56
of an underlying lesion ≥ HSIL/CIN2 [132]. There is related to the cellular cycle, and the maintenance
currently an automated detection system for p16 / of minichromosome protein-2 (MCM2) and
Ki67 to improve the stratificaiton of risk of CC [133]. topoisomerase II (TOP2A), the genes of which are
• DNA methylation: The utility of epigenetic alterations over expressed in ΩCC [134] and are detectable
in the detection of premalignant lesions of the cervix by microarray-based technology. ProEx C is a new
with capacity of progression (HSIL/CIN3) has been immunohistochemical marker for the detection of the
evaluated. Epigenetic silencing of tumor suppressor MCM2 and TOP2A proteins. Increased expression of
genes by hypermethylation of the promotor is one of these proteins seems to be associated with HPV 16
the earliest epigenetic alterations in many neoplasms and HSIL [135]. Different combinations of cytological
in oncologic transformation and may be an early evaluaton, HPV test and ProExC staining have been
marker of malignant transformation. Many studies compared, and it was found that primary screening
related to the hypermethylation of different genes based on the DNA of high riks HPV followed by
involved in the development of cervical cancer such ProExC triage was the best screening strategy for
as CADM-1, MAL, FAM have been performed. detecting ≥HSIL/CIN2
• MCM2/TOP2A (ProEx C): Recent studies of
transcriptional profiles have identified 2 proteins
Table 10.5. Risk of lesion ≥ HSIL/CIN2 in women with previous high risk.
Stratum Study Author Population N ≥CIN2 Proportion ≥CIN2

Aue Aungkul et al. [128] HSIL 133 119 0,89
HSIL 1781 1643 0,92
ALTS Bosgraaf et al.[129].[88] ASCUS/LSIL 411 246 0,60
HSIL sólo
BD HPV + 124 105 0,85
Biopsy Study ≥ASCUS 206 127 0,62
Pooled Estimate 2655 2240 0,79 (0.61-0.93)
Aue_Aungkul et. al. [128] HSIL 110 102 0,93
HSIL 1543 1473 0,95
High grade
ALTS Bosgraaf et al.[129] 155 122 0,79
colposcopy
BD 17 13 0,76
and HSIL
Biopsy Study 108 81 0,75
Pooled Estimate 1933 1791 0,86 (0,73-0,95)
DSI Trial Zaal et al. [130] BMD Twvice 18 17 0,94
High grade ALTS 182 133 0,73
colposcopy
BD 31 19 0,61
and HPV
Biopsy Study 83 65 0,78
16/18 +
Pooled Estimate 314 234 0,76 (0,66-0,85)
ALTS 171 128 0,75
HSIL y HPV BD 46 31 0,67
16/18 + Biopsy Study 91 67 0,74
Pooled Estimate 308 196 0,73 (0,54-1)
High grade ALTS 105 90 0,86

colposcopy BD 9 8 0,89
HSIL and HPV Biopsy Study 57 45 0,79
16/18 + Pooled Estimate 171 143 0,85 (0,78-0,90)
CIN: cervical intraepihtelial neoplasia; HSIL high grade squamous intraepithelial lesion; ASCUS atypical squamous cells of undetermi-
ned significance. ALTS, ASCUS/LSIL Triage study for cervical cancer;
BD, Beckton Dickinson; DSI, Dynamic Spectral Imaging; BMD, borderline mild dyscariosis.
[58] Reproduced from Wentzensen N, M Schiffman, Silver MI, Khan MJ, Perkins RB, Smith KM, MD, Gage JC, Gold MA, Conageski C,
EinsteinMH,Mayeaux EJ, Waxman AG, Huh WK, MD, Massad LS. ASCCP Colposcopy Standards: Risk-Based Colposcopy Practice. J
Low Genit Tract Dis 2017;21: 230–234.
57
AEPCC-Guías
11. Summary of the recommendations and standards

of quality in colposcopy.
2. SAMPLE COLLECTION FOR THE SCREENING OF CERVICAL CANCER
Recommendations
2.1 Cytological smear

• Ideally the cytological smear should be done when the patient is not menstruating.
• The presence of signs of suspicion of an invasive cervical lesion implies the need to refer the patient
for a specific gynecological study.
• The cytological smear should obtain samples from the exocervix and endocervix.
• The cytological smear should preferably be done in liquid mediuam with a plastic spatula and
cytobrush or with a single device. Conventional smear and extension on a slide is acceptable.
• The cytological reports should be made according to the Bethesda terminology.
2.2 Sample collection for HPV testing

• The HPV testing test should be approved by the regulatory agencies (FDA) or fulfill the criteria of
equivalence of sensitivity and specificity.
• The HPV sample should obtain material from the exocervix and the transformation zone.
• The HPV sample should preferably be made in liquid medium with a plastic spatula and cytobrush or
with a single device.
• According to the method selected, in primary screening the report of HPV test result should provide
information of a positive high risk HPV test or specifically for each of the genotypes or for genotypes
16 and 18.
2.3 Sample collection in special clinical situations

• In cases with cervical stenosis, the endocervical sample may be obtained after dilatation. In difficult
cases it is preferable to take a sample for the HPV test.
• In cases of cervicitis, it is preferable to defer the cervical sampling until after performing a specific
treatment.
• In the case of severe atrophy, treatment with topical estrogens can be performed before the cytology
or making an HPV test.
• Screening in women with hysterectomy for SIL/CIN should continue for at least 20 years.
• Adequate cytology without cellular alterations but limited due to the absence of endocervical cells or
cells from the transformation zone is considered negative.
• In cases of inadequate cytology limited by the absence of endocervical cells or cells from the
transformation zone, the reflex HPV test or co-test may be performed after treatment with estrogens.
58
3. GUIDELINES FOR REFERRING A PATIENT TO COLPOSCOPY.

STANDARDS OF QUALITY.
Recommendations
3.1 Waiting time to perform colposcopy in asymptomatic patients with

an abnormal result in the screening tests.
• Colposcopic evaluation of a patient with ASCUS cytology and a positive HPV test should be
• Colposcopy evaluation of a patient with LSIL cytology should be performed within 8 weeks.
• Colposcopic evaluation of a patient with HSIL cytology should be performed within 4 weeks.
• Colposcopic evaluation of a patient with ASC-H cytology should be performed within 4 weeks.
• Colposcopic evaluation of a patient with AGC or AGC-H cytology should be performed within 4
weeks.
• Colposcopic evaluation of a patient with AIS cytology should be performed within 2 weeks.
• Colposcopic evaluation of a patient with a persistent HPV positive test of at least 1 year and
negative cytology should be performed within 16 weeks.
3.2 Waiting time for performing colposcopy in patients with symptoms

or suspicious findings in the routine gynecological examination.
• Colposcopic evaluation of a patient with symptoms suggestive of CC should be performed within 2
weeks.
• Colposcopic evaluation of a patient with a macroscopically abnormal cervix in the screening sample
should be performed within 2 weeks.
3.3 Waiting time between confirmed histological diagnosis after

colposcopy and treatment.
• All cervical treatments require a previous colposcopy study performed in a Colposcopy Unit by
specialized professsionals.
• The treatment of HSIL/CIN2-3 should be performed in less than 8 weeks.
• Excisional procedures should present less than 5% of hemorrhagic complications and less than 2%
of readmissions.
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AEPCC-Guías
5. NOMENCLATURE AND DESCRIPTION OF COLPOSCOPIC FINDINGS.
Recommendations
5.1 Terminology
• The colposcopic terminology of the IFCPC 2011 Classification should be used in clinical practice.
5.2 Accuracy of colposcopic diagnosis

• The principal objective that colposcopy terminology should pursue is to obtain the best correlation
between the colposcopic findings and the histological lesion.
• Acetowhite changes have a greater grade of correlation, and this increases with the evaluation of
the vascular pattern and borders of the lesion.
• Some recently introduced colposcopic signs (inner border or white on white, ridge sign and rag
sign) have an elevated specificity and PPV for lesions ≥ HSIL/CIN2.
5.3 Benefits of colposcopy

• The use of colposcopy shows its greatest benefits in the detection of lesions (guides biopsy and
allos histological confirmation).
• Conizations should be performed under colposcopic control.
5.4 Potencial harmful effects of colposcopy

• The principal harmful effects of colposcopy reported by patients are pain and anxiety.
• Underdiagnosis or the excesss of non justified biopsies are the principal potential harmful effects
associated with colposcopy performed by unexperienced professionals.
60
6. STANDARDS OF QUALITY IN COLPOSCOPY DIAGNOSIS (I)
Recommendations
6.1 Registry of the clinical history of patients referred to colposcopy

• Anamnesis in the first colposcopic visit should be exhaustive and include the patient’s history (parity,
HIV/immunosuppression), hormonal situation, contraception and data on premalignant disease (HPV
vaccination, data and result of the screening tests, history of DIL and previous treatments).
• Prior to colposcopy it is essential to report the indication and the result of the screening tests.
• Prior to colposcopy women should receive verbal information regarding the characteristics of the
procedure, and ideally, they should provide informed consent.
6.2 Colposcopic examination

• The colposcopic examination should always be performed following a systematic methodology.
• Colposcopic evaluation of the vagina should be systematic and may be facilitated using low
magnification and lugol solution.
• Colposcopic evaluation of the vulva can be facilitated using low magnification and acetic acid solution
at 5%.
6.3 Reporting and registry of colposcopic findings.

• Description of the colposcopic findings should be exhaustive and rigorous.
• Colposcopic evaluaton of the visualization of the cervix, description of the squamocolumnar junction
and the type of transformation zone should be performed in all the cases.
• In the case of a cervical lesion, colposcopic evaluation of the characteristics of the lesion (type,
localization in the cervix, visibility and semiology) is mandatory.
• Registry of the colposcopic images is essential (preferably by colpophotgraphies in the electronic
clinical history). As an option they may be registered using schemas or diagrams.
• On completion of the colposcopic examination, the colposcopic impression should be reported
according to the IFCPC terminology in all the cases.
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AEPCC-Guías
6. STANDARDS OF QUALITY IN COLPOSCOPIC DIAGNOSIS (II)
Recommendations
6.4 Colposcopy-guided biopsies

• Cervical biopsy should always be guided by colposcopy. The sample should select areas of greatest
abnormality and should contain an adequate representation of the epithelium and the stroma
(percentage of satisfactory biopsies greater than 90%).
• Selection of the most significant epithelial area to perform the directed biopsy should take the
colposcopic impression into account.
• Taking a single directed biopsy of the colposcopic area with the greatest abnormality has a lower
sensitivity for the detection of a lesion ≥ HSIL/CIN2 than the taking of multiple biopsies.
• Based on the lesion characteristics and the risk of lesions ≥ HSIL/CIN2, directed biopsies of the
different abnormal colposcopic areas are recommended (generally between 1 to 4).
• Directed biopsies should take into account the level of risk of a lesion ≥ HSIL/CIN2 which depends on
the cytology result, the presence of HPV 16/18 and the colposcopic impression.
• Do not perform biopsies in women with a low risk of lesion ≥ HSIL/CIN2: cytology < HSIL, no HPV
16/18 and a normal colposcopic impression.
• Perform directed biopsies in women over 25 years of age, not pregnant, with a high risk of lesion ≥
HSIL/CIN2 and at least 2 factors: HSIL cytology, HPV 16 or 18, colposcopic impression with grade
2 changes.
• If there is a high risk of lesions ≥ HSIL/CIN2, immediate excisional treatment can be performed in
selected cases if they fulfill the criteria in the previous point.
• Non directed biopsies (within the transformation zone) can be performed in cases in which the
colposcopic impression shows no evidence of lesion but there is a risk of
• HSIL/CIN2.
• Non directed biopsies should never be performed in cases with a low risk of lesions ≥ HSIL/CIN2.
• Endocervical study with curettage or brush should be performed when the colposcopic lesion shows
an endocervical component (more frequent in menopause or post-treatment).
• An endocervical study immediately post-conization is indicated since it has an elevated predictive
value of lesion persistence.
• Endocervical curettage is contraindicated during pregnancy.
6.5 Reporting and registry of biopsies

• It is essential to correctly report and register all the cervical biopsies (number, localization, and
colposcopic characteristics).
• Following biopsy sampling the histological report should be available within a time of less than 4
weeks.
• Patients should receive verbal and written communication of the colposcopy results and of the
complementary studies performed.
62
7. COLPOSCOPY UNITS. STANDARDS OF QUALITY (I)
Recommendations
7.1 Standards of Quality of the Colposcopy Unit.

• The percentage of positive directed biopsies for lesions should be ≥ 80%
• Globally, the sensitivity and specificity of colposcopy in the diagnosis of lesions ≥ HSIL/CIN2 should
be ≥ 80% and ≥ 70%, respectively.
• The number of conizations performed per year should be registered.
• The percentage of conizations performed in the outpatient setting should be ≥ 70%.
• The percentage of conizations performed under colposcopic control should be ≥ 90%.
• The type of treatment performed in all cases should be registered.
• A lesion ≥ HSIL/CIN2 should be confirmed in ≥ 70% of the conization pieces.
• The percentage of conizations without histological lesions should be ≤ 15%.
• The percentage of conizations with lesions positive for lesion should be ≤ 20% (≤ 15% of endocervical
margins).
• The percentage of HSIL cytologies at 6 months should be ≤10% and ≤5% at 24 months.
• The percentage of compliance with recommended waiting times should be ≥ 90%.
• The percentage of compliance with the vaccination schedule for HPV in women after conization
(according to the protocols of each autonomous community) should be ≥ 90%.
• The annual number of claim or complaints should be registered and analysis of the reasons for these
claims should be performed.
• The annual number unit or interdisciplinary sessions should be registered.
• Correctly report (preferably in writing) the objectives of the screening tests and the possibility of
complementary studies (≥ 90%) and the results of the screening tests and colposcopy (≥ 90%).
• The patient must be informed of the results within a maximum of 8 weeks.
• The members of the Colposcopy Unit should be accredited (ideally ≥ 50%).
• The Colposcopy Units must coordinate and achieve consensus regarding the referral of patients from
screening programs based on regional or national guidelines.
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AEPCC-Guías
7. COLPOSCOPY UNITS. STANDARDS OF QUALITY (II)
Recommendations
7.2 Personnel, installations and equipment of a Lower Genital Tract Unit.

• The medical personnel of the Colposcopy Unit should be experienced and staffing and organization
should allow correct patient care, quality control, teaching and continuing education.
• The nursing personnel should be qualified and integrated in the functioning of the unit.
• The installations and equipment of the Colposcopy Units should fulfill the health care requisites of
safety, equipment, and confidentiality.
7.3 Organization and administrative managment

• The organization of the Colposcopy Unit requires a specific organigram and administrative support
as well as specialized nursing personnel.
• The specialists of the Colposcopy Unit should periodically meet (preferably every 1 or 2 weeks).
• Multidisciplinary meetings with specialists related to the Colposcopy Unit should be held every
trimester.
7.4 Clinical documentation

• The clinical activity of the Colposcopy Unit requires documentation which is standardized according
to the prevailing legislation.
• The principal documentation refers to: clinical history, informed consent, authorizations, discharge
reports, and informative documents.
• Informed consent registered in the clinical history should be obtained in > 95% of all the procedures
performed.
64
8. INFECTIONS, CYTOLOGY AND COLPOSCOPY
Recommendations
8.1 Sample collection for the study of infections in the colposcopy visit.
• A screening visit for CC cannot be used to perform screening for infections of the lower genital tract.
8.2 Action towards infections found in cytology

• Cytological detection of actinomyces has a low sensitivity, specificity, NPV and prognostic value. In
asymptomatic women neither IUD extraction nor specific treatment is necessary.
• Cytological detection of Tricomonas vaginalis can occur in asymptomatic patients or in women without
signs of cervicitis. In all the cases, both the patient and partner should receive treatment.
• Cytological detection of Candidas is frequent, although this method is not considered to be very
sensitive. In asymptomatic patients, this finding is not an indication for treatment. Other associated
infections should be ruled out.
• Cytological detection of bacterial vaginosis is frequent. The presence of characteristic clue cells is not
diagnostic of infection. The diagnosis and treatment should be based on clinical criteria.
• Cytological detection of Chlamydia tracomatis presents a very low sensitivity. This finding is of
interest in symptomatic women or in those with inflammatory pelvic disease. Liquid cytology samples
are adequate for peforming NAAT techniques.
• Cytological detection of intraplasmatic diplococci is not always diagnostic of infection by Neissereia
gonorrhoaea (confirmatory techniques are always required). Liquid cytology samples are adequate
for performing NAAT techniques.
• The specificity of cytology for the detection of findings suggestive of herpes simplex is high, but the
sensitivity is low. Specific techniques such as PCR are necessary for confirmation. Liquid cytology
samples are adequate for performing these techniques.
8.3 Informing patients of the results

• Cytology may suggest or confirm a genital infection. There should be protocols regarding in which
cases the study should be widened or treatment or specific follow-up should be performed in both the
patient and her partner.
• On informing the patient of the presence of a STD in the cytology results, the impact this may have
on the patient and partner should be taken into account.
65
AEPCC-Guías
9. COLPOSCOPY STANDARDS IN SPECIAL SITUATIONS
Recommendations
9.1 Pregnancy
• Colposcopy in pregnant women should be performed based on a specific indication by experienced
professionals and in Colposcopy Units.
• Colposcopic evaluation during pregnancy is more complex due to the physiological changes in the
cervix.
• The principal objective of colposcopy in pregnant women is to rule out CC. On clinical and colposcopic
suspicion, biopsy or even conization should be performed.
9.2 Menopause
• Colposcopy during menopause is more difficult due to the associated atrophy.
• Treatment with topical estrogens can facilitate both evaluation of the cytological sample as well as
interpretation of the colposcopy.
• Postmenopausal genital hemorrhage is not an indication for screening but rather for gynecological
examination to exclude an eventual gynecological cancer.
9.3 Use of contraceptive

• The benefits and risk of taking contraceptives by patients with premalignant cervical lesions or HPV
infection should be individually evaluated.
• The WHO does not recommend any change in schedules which may induce an increase of unwanted
pregnancies.
9.4 Hysterectomy
• Women with negative screening results and hysterectomy for any disease not related to HPV should
discontinue screening.
• Women treated with hysterectomy for diseases related to HPV should undergo the corresponding
post-treatment follow-up and continue with screening for at least 20 years.
66
10. COLPOSCOPY PRACTICE ACCORDING TO THE LEVEL OF RISK
Recommendations
10.1 Definition of risk of premalignant cervical lesion according to

molecular, morphologic and colposcopic markers.
• On abnormal results in the screening tests the markers of risk are evaluated: cytology (morphological),
HPV test (molecular) and colposcopic impression (colposcopic). The need for colposcopy and
directed biopsies is determined depending on the level of risk.
• Women with a low risk of lesion ≥ HSIL/CIN2 are those who fulfill the criteria of: cytology <HSIL,
negative HPV 16/18 and normal colposcopy.
• Women with a high risk of lesion ≥ HSIL/CIN2 are those who fulfill at least 2 criteria of: cytology ≥
HSIL, AGC or ASC-H; positive HPV 16/18; colposcopy with grade 2 changes.
• Women with an intermediate risk of lesion ≥ HSIL/CIN2 are those who are not among the previous
2 groups.
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AEPCC-Guías
STANDARDS OF QUALITY IN COLPOSCOPY PRACTICE
Waiting times for performing colposcopy Standard fo quality Recommendation
Asymptomatic patients with ASCUS cytology < 8 weeks ≥ 80% of the cases
Asymptomatic patients with LSIL cytology < 8 weeks ≥ 80% of the cases
Asymptomatic patients with HSIL cytology < 4 weeks ≥ 80% of the cases
Asymptomatic patients with ASC-H cytology < 4 weeks ≥ 80% of the cases
Asymptomatic patients with AGC and AGC-H

< 4 weeks ≥ 80% of the cases
cytology
Asymptomatic patients with AIS cytology < 2 weeks ≥ 80% of the cases
Asymptomatic patients with negative cytolog-

yand persistent postive HPV determination
Patients with symptoms compatible with CC < 2 weeks ≥ 80% of the cases
Patients suspected of having an infiltrating

lesion in the cervix
Information to patients Standard of quality Recommendation
Information of screening tests (preferably

Percentage of women informed ≥ 90%
written material)
Information regarding screening results Percentage of women informed ≥ 90%
Information of clinical action derived by the

Percentage of women informed ≥ 90%
results of the screening tests
Waiting time to inform of result of screening

< 8 weeks ≥ 90%
tests
Informed consent for procedures Completed ≥ 90%
Training, sessions Standard of quality Recommendation
Training of physicians in the unit

Percentage of accredited
Accreditation for colposcopy ≥ 50%
physicians in the unit
Sessions
Unit sessions Every 1-2 weeks Register annual number
Multidisciplinary sessions Every trimester Register annual number
68
Health care activity in colposcopy Standard of quality Recommendation
Description and registry of the characteristics

of the lesion (type of lesion, localization, visibi- Document ≥ 90%
lity and semiology)
Colposcopic impression Document ≥ 90%
Grade 2 colposcopic changes Correlation with ≥HSIL/CIN2 ≥ 70%
Direct biopsies Adequate for evaluation ≥ 90%
Direct biopsies positive for

Directed biopsies ≥ 80%
SIL/CIN
Percentage of patients with HSIL/

Sensitivity of colposcopy ≥ 80%
CIN correctly diagnosed
Percentage of patients without

Specificity of colposcopy ≥ 70%
SIL/CIN correctly diagnosed
Conizations Number of cases per year Register
Outpatient conizations (in consulting office Porcentaje del total de

≥ 70%
with local anesthesia) conizaciones
Percentage of total number of

Conizations under colposcopic control ≥ 90%
conizations

Conizations with lesion ≥ HSIL/CIN2 ≥ 70%
conizations

Conizations without histological lesion ≤ 15%
conizations

Conizations with positive margins ≤ 20%
conizations

Conizations with positive endocervical margin ≤ 15%
conizations
Persistence/recurrence of lesion ≥ HSIL/CIN2 At 6 months after treatment ≤ 10%
Persistence/recurrence lesion ≥ HSIL/CIN2 At 24 months after treatment ≤ 5%
HPV vaccination in conized women (according

Percentage of women vaccinated ≥ 90%
to protocol in each autonomous community)
Claims and complaints Number and reasons Register
69
AEPCC-Guías
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Annex 1
Information for patients [80, 81]
What is colposcopy / vaginoscopy / not usually produce additional disturbances to those which
vulvoscopy? occur with cytology sampling or the human papilloma virus
This procedure is carried out to explore the cervix / vagina test.
/ vulva using a low magnificantion lens called “colposcope”
which can examine the zone with the greatest accuracy. During the test a transparent liquid called acetic acid will
After applying a series of liquids, premalignant lesions of be applied to the vulve/vagina/cervix, and sometimes
the epithelium become visible, and we can observe their another dark colored liquid is applied called lugol. These
size and exact localization. If any alteration suggestive of liquids highlight abnormal areas facilitating the identification
a lesion is visualized, a small biopsy of the abnormal area of lesions. On some occasions, there may be a slight, non
will be performed. With the analysis of the biopsy sample, painful, sensation of burning or stinging which disappears
the diagnosis can be obtained. This diagnosis, together with after a few minutes.
the characteristics of the colposcopy examination and the
characteristics of the patient are essential to define which If it is necessary to take a biopsy this will be done at the
cases should be treated or should simply undergo periodic same time. Biopsy sampling is not usually painful, but some
controls. disturbance may be felt, although, in general, this is well
tolerated. In some localizations it may be necessary to also
Why is necessary to perform this use local anesthetics to alliviate the sensation of pain and
examination? the application of substance to avoid bleeding afterwards.
Colposcopy/vaginoscopy/vulvoscopy is a test performed by In exceptional cases and in very specific genital zones,
a gynecologist specialized in colposcopy. This procedure is the use of other methods such as small sutures may be
used to study the cervix/vagina/vulva in depth and detect necessary to avoid bleeding. If any sample is obtained, this
whether there are any abnormalities which should be will be sent to a laboratory for analysis.
treated or controlled without treatment.
Recommendations after the examination
It is advisable to perform this test for several reasons. • Most women can return to normal activity immediately
The most frequent cause is an alteration in the screening after this test. Some women feel discomfort or mild
tests (cytology or human papilloma virus test). In this genital cramps which generally disappear within one
case, colposcopy can visualize lesions (if present), their or two hours. If necessary, an analgesic medication
localization and their characteristics. used normally can be taken.
The information obtained with the test is important for • It is advised to use a sanitary pad to protect your
deciding the most adequate clinical action to take with the underwear during the hours after the test to avoid
patient. staining by the liquids used, especially the lugol
solution (iodine solution). Due to the use of these
Do I need any preparation before the liquids it is possible that you will have brown or black
examination? vaginal secretions during the following days.
• Do not apply any cream or treatment to the external • If a biopsy has been taken do not use creams or
genital region during the two days before the test. treatments (except if specified) in the zone. In addition,
• Do not have sexual relations during the two days do not have sexual relations or immersion baths or
before the test. vaginal douches in the following two days.
• If you have your period on the day of the test it is • If a biopsy has been taken, there may also be genital
better to delay the examination. bleeding/spotting which should be scarce and of short
duration. To the contrary it is advised to be visited
What does the examination consist of? again.
Colposcopy / vaginoscopya /vulvoscopy is performed
in the consulting office similar to the usual gynecological
examination. It lasts approximately 10-15 minutes and does
75
AEPCC-Guías
Annex 2
Informed consent
This informative document aims to explain, as simply as possible, the intervention called
colposcopy, vaginoscopy, vulvoscopy
as well as the most important aspects of the post-intervention period and the most frequent complications which may
appear as a consequence of the intervention. This document has the objective of providing you with adequate information
prior to your consent to undergo the intervention according to the Regulating Basic Law of the autonomy of the patient and
the rights and obligations related to clinical information and documentation (41/2002).
Mr./Ms. ………………………………...................................... cwith ID/passport nº…………………..as the patient.
I DECLARE
that the medical team attending me has informed me of the need to undergo the test described.
Informed consent for performing colposcopy / vaginoscopy / vulvoscopy.
1. . I have satisfactorily been informed by Dr …………… 4. Due to my current situation the doctor has informed me
………………………………………………...........of the fo- that complications may increase or appear (specify):
llowing points: that is, what colposcopy / vaginoscopy / vul- ……………………………………………………………………
voscopy is, how it is performed, why it is performed, the ………………………………..….............................................
possible risks and the possible disturbances or complica- ..............................................................................................
tions of the procedure. In addition, I have been advised of
the precautions that should be taken after the procedure. 5. The doctor has explained that the sample obtained du-
ring the procedure will be sent for analysis.The results of
2. Description of the procedure to be authorized: colposcopy this analysis will be reported to me, or failing that, my family
/ vaginoscopy / vulvoscopy: and/or legal representative. In addition, the doctor has exp-
Colposcopy /vaginoscopy /vulvoscopy is carried out to ex- lained to me and I have understood that depending on the
plore the cervix / vagina / vulva using a low magnification results of this analysis another type of study may be neces-
lens called “colposcope” which can examine the zone with sary, and on occasions, determined surgical procedures.
greater accuracy. After applying a series of liquids, the pre-
malignant lesions of the epithelium become visible, and we 6. The doctor has explained to me the possibility of perfor-
can observe their size and exact localization. If any altera- ming photographies and/or videos of the images of the pro-
tion suggestive of a lesion is visualized, a small biopsy of cedure for medical purposes and for scientific investigation,
the abnormal area will be performed. With the analysis of ensuring at all times the anonymity of all the data which
the biopsy the diagnosis can be obtained. This diagnosis is could facilitate recognition of my person.
essential to define which cases should be treated or should Under the conditions described, I authorize / do not authori-
simply undergo periodic controls according to the grade and ze (cross out what is not applicable) the taking of photogra-
characteristics of the lesion and the patient. phies and/or videos of images of the procedure.
3. The complications and/or risks of the procedure are: 7. I have understood the explanations given to me in clear
• Pain during and after the procedure (generally mild) simple language, and the doctor attending me has allowed
which requires the use of analgesics and/or may trig- me to make comments and has clarified all my questions/
ger vagal reaction requiring specific measures of action doubts. I also understand that at any time and without any
(medication, observation). explanation I can revoke the consent which I now render.
• Adverse reactions and/or allergies to the products and/
or drugs (local anesthetics, hemostatic drugs) used du- 8. I thereby state that I am satisfied with the information
ring the procedure. received and under such conditions I give my consent to
• Bleeding during and after the procedure (generally undergo a colposcopy / vaginoscopy /
mild) requiring suture points and emergency care (ex- vulvoscopy.
ceptionally).
• Infections of the biopsy site requiring health care and
complementary treatments.
76
Annex 2
Informed consent
Consequently, I render my Consent for the performance of the procedure described.
SIGNATURE OF THE PATIENT SIGNATURE OF THE INFORMING PHYSICIAN
Date: ………………………………. Date: ……………………………………….

Name of the legal representative in the case of patient discapacity indicating the relationship of this person with the patient
(father, mother, tutor, etc.).
Name and surname.........................................…………………………………………………. ID nº………………………………
As the......................................………......................................………......................................………........................

SIGNATURE OF THE REPRESENTIVE
Date: ……………………………….
REVOCATION
Mr/Ms ………………………………..................................................................with ID/passport nº………………………. As

the patient, or in his/her absence, Mr/Ms………………………………………...........................................................with ID/
passport nº………………………….., as legal representative and/or tutor of the patient of legal age, state that I REVOKE
the consent rendered on the date of ...………………………….
Signature: Physician Signature: The patient Signature: Legal representative/relative
77
AEPCC-Guías
78
79

10a Aepcc Guidelines Colpos

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ISBN 978-84-09-06631-5

The specific objectives pursued by the AEPCC-Guidelines are:

3. EVALUATION OF THE SCIENTIFIC EVIDENCE.

COLPOSCOPY GUIDELINES STANDARDS OF QUALITY

6.2 Colposcopic examination.......................................... 30 7.5.1 Training and certification of colposcopists.......... 45

7. COLPOSCOPY UNITS. STANDARDS OF QUALITY 10. COLPOSCOPIC PRACTICE ACCORDING

Participants COLPOSCOPY GUIDELINES STANDARDS OF QUALITY

2. Sample collection for screening of cervical cancer

Before describing cytological smear collection in depth, study.

it is important to note that if clinical signs suggestive of

The days of the menstrual cycle should be taken into

The transfer of the cervical smear differs according to

In the case of liquid cytology, the spatula and the cytobrush

Both the classical cytology on slides and liquid cytology are

Recommendation: cytological reports should be

after an abnormal cytology result such as, for example an

The information provided in the HPV test reports depends on

In general, it is logical to think that the sample in liquid

CLINICAL SITUATIONS sample.

Some situations may present specific characteristics. Each

2.3.1 Cervical stenosis 2.3.3 Severe atrophy

2.3.6 Absence of endocervical cells or

Patients undergoing total hysterectomy with no previous for evaluation.

history of SIL/CIN should not continue with the screening

cancer. can be assumed that the screening is negative); 2) if HPV

hysterectomy due to benign disease found a reduced in 6-8 weeks [17].

number of cases of vaginal SIL (less than 1%) and no case

justified in patients with no history of SIL/CIN undergoing colposcopy.

Recommendation: Cytology results without cellular

the cervix, rectum, bladder or other pelvic organs. These

3. Guidelines for referring a patient to colposcopy.

3.1 WAITING TIME TO PERFORM 3.1.1 Cytology showing atypical

is directly related to a delay in implementing adequate

Recommendation: Colposcopic evaluation should Recommendation: Colposcopic evaluation should

is also infrequent (between 0.27 and 0.6% of all screening

Nonetheless, considering the high probability of the cervical neoplasia [27].

presence of a severe underying lesion, rapid evaluation

Recommendation: Colposcopic evaluation should Recommendation: Colposcopic evaluation of

3.1.6 Cytology showing adenocarcinoma

3.2.1 Women with symptoms suggestive

In these women it is recommended to take a biopsy of the

Recommendation: Colposcopy should be perfor-

3.3 Waiting time between confirmed

All patients who are candidates to receive treatment should

All the treatments of high grade premalignant lesions should

The patients should be informed of the need for and type

When treatment is indicated in women with HSIL/CIN2-3,

4. Colposcopy instruments and material

in the colposcopic images facilitate control of the quality of used.

any type of forceps or procedure. a examination table, set up on a pedestal or be

knob (micrometric focus). wheels for purposes of mobility.

• Filters: green or blue filters are available for

4.1.2 Colposcope accessories. 4.2.1 Instruments for colposcopy access

4.2.2 Fungible material 4.2.4 Other materials

5. Nomenclature and description of colposcopic

At present, 2 colposcopic classifications are the most

Pathology and Colposcopy (IFCPC) [1] (Table 5.1) and the

internationally accepted.The last update of this classification

Colposcopy terminology of the cervix of the IFCPC 20111