Intra-Abdominal Drainage For Laparoscopic Cholecystectomy
Intra-Abdominal Drainage For Laparoscopic Cholecystectomy
Intra-Abdominal Drainage For Laparoscopic Cholecystectomy
Review
h i g h l i g h t s
a r t i c l e i n f o a b s t r a c t
Article history: Aim: To assess the effectiveness of intra-abdominal drainage (IAD) post laparoscopic cholecystectomy
Received 27 May 2015 (LC).
Received in revised form Methods: Main electronic databases [MEDLINE via Pubmed, EMBASE, Scopus, Web of Knowledge,
23 August 2015
Cochrane Central Register of Controlled Trials (CENTRAL) and the Cochrane Library, and clinical trial
Accepted 2 September 2015
Available online 18 September 2015
registry (ClinicalTrial.gov)] were searched for randomised controlled trial (RCT) reporting outcomes of
IAD. The systematic review was conducted in accordance with the PRISMA guidelines and meta-analysis
was analysed using fixed and random-effects models.
Keywords:
Surgical drain
Results: Twelve RCTs involving 1763 patients (897 drained versus 866 without drain) were included in
Laparoscopic cholecystectomy the final pooled analysis. There was no statistically significant different in the rate of intra-abdominal
Complications collections (RR 1.08, 95% CI 0.78 to 1.49; p ¼ 0.65). IAD did not reduce the overall incidence of nausea
and vomiting (RR 1.10, 95% CI 0.90 to 1.36; p ¼ 0.36) and shoulder tip pain (RR 0.99, 95% CI 0.69 to 1.40;
p ¼ 0.93). Drain group had a significant higher pain scores (measured by visual analogue scale) (MD
10.08, 95% CI 5.24 to 14.92; p < 0.00001). IAD prolonged operative time (MD 4.93 min, 95% CI 3.40 to
6.47; p < 0.00001) but not the length of hospital stay (MD 0.22 day, 95% CI 0.45 to 0.89; p ¼ 0.52).
Wound infection was found to be unrelated to the use of a drain (RR 1.86, 95% CI 0.95 to 3.63; p ¼ 0.07).
Conclusions: There is no significant advantage of IAD placement. The routine use of abdominal drain
seems to have unfavourable clinical outcome and the practice should be carefully re-considered.
© 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.ijsu.2015.09.033
1743-9191/© 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.
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88 C.S. Wong et al. / International Journal of Surgery 23 (2015) 87e96
formation in a contaminated abdomen [4]. Therefore, prophylactic the gold standard of treatment for symptomatic gallstone disease
drainage has gained wide acceptance as a useful tool to prevent [9]. The primary outcome, in this review, was intra-abdominal
post-operative complications after gastrointestinal surgery. collections (bile leak or biloma, bleeding or abscess) and second-
Although IAD may have a therapeutic and prophylactic role in ary outcomes were as follow: wound infection, abdominal pain,
minimizing post-operative complication, there are potential drain- nausea and/or vomiting, shoulder pain, length of hospital stay and
related complications such as bleeding or haemorrhage and direct duration of surgery.
damage to the bowel anastomosis or adjacent organ structures and
vessel within the peritoneal cavity [5,6]. Drain site can be painful 2.2. Data extraction and validity assessment
and cause discomfort to the patient. The placement of drains in
contaminated incisions may increase the incidence of surgical site Article reference lists were scrutinised for relevant articles and
infection [7]. Dysfunction of the drain (blockage, dislodge, kinking) methodological quality of the included studies was independently
and drain site herniation may serve more problems than they solve. assessed by two authors (CSW and JCD). Any differences in opinion
The value of prophylactic drains remains controversial. The were resolved through discussion. Study design and level of evi-
primary indication for the placement of a drain is to prevent fluid dence of all identified studies were categorised according to the
collections and subsequent infection. Prophylactic drainage may be Oxford Centre for Evidence-Based Medicine (CEBM) levels of evi-
beneficial for the procedures that are frequently associated with dence [10]. Risk of bias was evaluated as per Cochrane methodology
large collections of blood and serum (e.g. hepatic, pancreatic sur- [11]. Potential sources of bias (selection bias, performance bias,
gery). In other GI surgery, drains prevent the development of deep detection bias, attrition bias, reporting bias) were identified and
wound infection such as local abscesses associated with perforated graded as ‘low risk of bias’, ‘high risk of bias’, or ‘risk of bias unclear’
appendicitis. Many surgeons would also drain the abdomen when using Cochrane ‘Risk of Bias’ assessment tool published in the
they anticipate insecure bowel anastomosis or bleeding in gall- Cochrane Handbook for Systematic Reviews of Interventions
bladder, pancreatic, and splenic surgery. Some surgeons advocate Version 5.1.0. Funnel plots presented with a log RR (mean differ-
that drainage of the peritoneal cavity is ineffective and, therefore, ence in the case of continuous variables) on vertical Y-axis and
prophylactic drainage is not recommended. Drain should only be effect size on horizontal X-axis were visually assessed for possible
used when there are clear indications intra-operatively. This is a publication bias.
common surgical operative dilemma faced by general surgeons
across all surgical subspecialties. 2.3. Quantitative and statistical analysis
We carried out a systematic review and meta-analysis to
examine the effectiveness of IAD post laparoscopic cholecystec- Inclusion criteria for meta-analysis were RCTs of any sample size
tomy, the second commonest operative procedure after which compared abdominal drainage and no drainage reporting
appendicectomy. primary outcome (i.e. intra-abdominal collections) and other
related complications. A meta-analysis was performed using the
2. Material and methods software package Review Manager (RevMan) Version 5.3.4 (Java 6
64 bit) to characterise the drain effect on various dichotomous and
The systematic review assessing the outcomes of IAD in lapa- continuous outcomes. For dichotomous variables, we characterised
roscopic cholecystectomy (LC) was conducted in accordance with the drain effect by risk ratio (RR) with 95% confidence interval such
the PRISMA guidelines [8]. The electronic databases MEDLINE via that values less than 1 favour drains, whereas values larger than 1
Pubmed, EMBASE, Scopus, Web of Knowledge, Cochrane Central favour no drains. For continuous variables, we calculated stand-
Register of Controlled Trials (CENTRAL) and the Cochrane Library, ardised mean difference (SMD) with 95% confidence interval in
and clinical trial registry (ClinicalTrial.gov) were searched using the order to take into account different scales used for the measure-
following search terms or key words. Keywords e ‘laparoscopic’, ment across these studies. Forest plots were generated to measure
‘cholecystectomy’, ‘drain’, ‘complication’. These terms were searched outcome variables comparing drain versus non drain group for all
using Boolean operators (AND and OR) and appropriate Medical the studies combined. A p-value of less than 0.05 is referred to as
Subject Heading (MESH) terms were combined in the search statistically significant throughout. Subgroup and sensitivity anal-
builder. A truncation symbol was used (e.g. adding superscript ysis on trials that reported the used of antibiotic compared to those
asterisk at the end of a word) wherever appropriate in our that do not was performed to eliminate potential effect of con-
searching strategy. For example: drain* would retrieve the free-text founding factors due to variability of intervention on wound
terms of ‘drains’, ‘drainage’, and ‘draining’ in the search. Searches infection outcome.
were not restricted by publication year, publication status or lan-
guage. Relevant conference abstracts and recent proceedings pre- 2.3.1Heterogeneity
sented at the American Surgical Association, Association of Outcomes of dichotomous (binary) and continuous variables
Surgeons of Great Britain and Ireland, Annual Conference of were measured using ManteleHaenszel fixed-effect [12] and Der-
American College of Surgeons were hand-searched. A manual Simonian and Laird [13] random-effects model. The degree of het-
search was conducted for reference lists in included studies. erogeneity observed in the result was quantified using the I-squared
(I2), which is presented as a percentage. A significant heterogeneity
2.1. Study selection presents when I2 > 50% [14]. The fixed-effect model was used if
there was no significant heterogeneity across studies. If significant
We included randomised controlled trials that met the heterogeneity is present; the random-effects were applied.
following criteria: (a) Randomised controlled trial (RCT); (b) Patient
undergoing LC surgery; (c) With reported outcome of drain versus 3. Results
non-drain (irrespective of the type of drain used); (d) Adult pop-
ulation. We excluded non-RCTs (case series, case-control study and A flow diagram of the search strategy is presented in Fig. 1. The
cohort study), reviews, and any studies conducted in paediatric age initial searches generated 3197 citations, of which 12 RCTs [15e26]
groups. We also excluded open cholecystectomy in our study were included in the final quantitative data analysis. The meta-
because laparoscopic cholecystectomy is now firmly established as analysis was performed with pooled data from a total of 1763
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C.S. Wong et al. / International Journal of Surgery 23 (2015) 87e96 89
3.1.1. Randomisation
All the trials had adequate generation of allocation sequence
either by using a computer random number generator [Hawasli
et al. [15]; Mrozowicz et al. [17]; Pichhio et al. [21]; Lucarelli et al.
[25]; Park et al. [26] ] or block randomisation [Nursal et al. [16];
Tzovaras et al. [19]; and El-labban [22]]. Six included trials
described the used of sealed envelopes in the generation of allo-
cation concealment [Uchimaya et al. [18]; Tzovaras et al. [19]; Pic-
chio et al. [21]; El-labban et al. [22]; Shamim et al. [23] and Lucarelli
et al. [25]]. The remaining of the authors did not describe methods
of allocation concealment.
3.1.2. Blinding
There were two trials that conducted double-blinding trials
[Picchio et al. [21], Lucarelli et al. [25]]. In these trials, both groups
(intervention and control) of patients were subjected to drain
insertion. However, in the control group, inserted drains were
made non-functional post-operatively. This way, patients were
blinded to the intervention and assessors were not aware of patient
allocation. Some authors mentioned that the randomisation was
performed at the end of the operation just before wound closure
after the haemostasis had been achieved [Tzovaras et al. [19]; El-
labban et al. [22]; Shamim et al. [23]]. Nursal et al. [16] and Park
et al. [26] conducted a single-blinded trial.
patients (897 drained versus 866 non-drain patients in uncompli- 3.2.2. Wound infection
cated LC). Overall, only two studies [21,23] were carried out in a The wound infection rate was 4.80% in the drain group
multicentre and the remainder were single-centre trials. A sum- compared to 2.56% in the no drain group. Meta-analyses showed no
mary of randomised controlled trials comparing characteristics and statistically significant rate of wound infection between drain and
outcomes of drains versus no drain was summarised in Table 1. no drain group across LC (RR 1.86, 95% CI 0.95 to 3.63) (Fig. 5).
Sensitivity analysis revealed non-significant difference in wound
3.1. Quality assessment infection when analysis confined to those studies reporting use of
antibiotics (RR 1.93, 95% CI 0.93 to 3.99).
The methodological quality of each included study was assessed
using the quality check list supplied in the Cochrane Handbook for 3.2.3. Effects of intervention on other outcomes
Systematic Reviews of Interventions, which contains six items: There was no statistically significant difference in these out-
random sequence generation, allocation concealment, blinding of comes e nausea and vomiting (RR 1.10, 95% CI 0.90 to 1.36) (Fig. 6)
participants and personnel, blinding of outcome assessment, and shoulder tip pain (RR 0.99, 95% CI 0.69 to 1.40) (Fig. 7).
incomplete outcome data, and selective reporting. Abdominal pain was lower in the drain group than no drain group
There were 12 studies included for risk of bias assessment. in the first 24 h but the difference was not statistically significant
Table 2 and Fig. 2 provide a table and a graph summary respectively (RR 0.96, CI 95% CI 0.81 to 1.14). When pain was measured by visual
for risk of bias in all included studies. Funnel plots as illustrated in analogue scale (VAS), it was statistically significantly greater in the
Fig. 3f and g showed only minor asymmetry indicates the presence drain group comparing to the no drain group (MD 10.08, 95% CI 5.24
of reporting bias. There was no asymmetry observed for other to 14.92) (Fig. 8). The operative time was significantly longer in the
outcomes of interest. drain group compared to non-drain group (MD 4.93 min, 95% CI
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90
Table 1
Randomised controlled trials of drains versus no-drain in all four domains. Abbreviation: RCT ¼ Randomised controlled trial; VAS** ¼ 100-point visual analogue scale; VAS* ¼ 10-points visual analogue scale; ROD ¼ removal of
drain; NR: not reported; IV ¼ intravenous; TDS ¼ three times a day; Ref ¼ Reference; *Based on http://www.cebm.net/oxford-centre-evidence-based-medicine-levels-evidence-march-2009/.
Author (year) [Ref] Study design and Number of Intervention Control group Outcomes measured Types, incision site and Duration of drain Use of antibiotics
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level of evidence* Participants group (drain) (no drain) placement of drains prophylaxis
uso personal exclusivamente. No se permiten otros usos sin autorización. Copyright ©2023. Elsevier Inc. Todos los derechos reservados.
Hawasli et al. (1994) [15] RCT (single centre) 100 50 50 Wound infection, abdominal Closed-suction (Vac drain) (via NR NR
pain, shoulder pain, nausea, epigastric trocar site)
postoperative fever, operative
time
Nursal et al. (2003) [16] RCT (single centre, 69 35 34 Postoperative pain (VAS**), Non-suction (Tube drain) (via ROD: Post-op day 1 (24 h) Yes; IV Cefazolin 1 g (at
single blinded) nausea or vomiting, shoulder lateral 5-mm trocar site) e induction)
tip pain, pulmonary subdiaphragmatic space
complication, duration of
operation
Mrozowicz et al. (2006) [17] RCT (single centre) 143 79 64 Abdominal pain, nausea, Non-suction drain ROD: Post-op day 1 (24 h) Yes; (?)
Table 2
Risk of bias summary of all included studies (n ¼ 12).
3.40 to 6.47) (Fig. 9). There was no difference in length of hospital either sub-phrenic recesses or sub-hepatic space. For the
stay (MD 0.22 day, 95% CI 0.45 to 0.89) (Fig. 10). remainder of gastrointestinal surgery, for example pancreatic
resection, cholecystectomy, gastrectomy, colectomy, and appendi-
4. Discussion cectomy, placement of drainage is carried out within the abdominal
cavity. This serves a common purpose which is to remove intra-
The use of drainage in contaminated and infected abdominal abdominal collections such as ascites, bile, blood, chyle and
surgery is declining [27] but it has been a routine practice for many pancreatic or intestinal juice. Unfortunately, the practice of using
years. For liver resection surgery, drain is usually inserted into prophylactic drainage in GI surgery was not based on any scientific
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92 C.S. Wong et al. / International Journal of Surgery 23 (2015) 87e96
evidence. In general, the effectiveness of post-operative drainage allocated drain group (MD 4.93 min, 95% CI 3.40 to 6.47;
remains controversial and debatable. p < 0.00001). Patient who had no drain inserted could be sent home
There are many different outcomes of interest across GI surgery; 5.28 h earlier but this was not statistically significant longer (MD
hence in this review, we have focused our attention on reporting 0.22 day, 95% CI 0.45 to 0.89; p ¼ 0.52). Heterogeneity was
the most closely related postoperative complications associated observed across continuous data outcome and this may be attrib-
with drain placement in LC surgery (i.e. intra-abdominal collec- uted to mixture cases of an elective or emergency surgery and
tion). This study has demonstrated that drainage does not decrease differences in the pathology of the disease (a mixture of choleli-
the incidence of intra-abdominal collection (RR 1.08, 95% CI 0.78 to thiasis, acute and chronic calculous cholecystitis, and gallbladder
1.49; p ¼ 0.65). In fact, the total number of abdominal collections polyp).
was higher in the drain group compared to the ‘no drain’ group. We subsequently performed sensitivity analysis on wound
This implies that IAD is ineffective in preventing the occurrence infection to eliminate potential confounding factor due to antibi-
intra-abdominal collections. Therefore, the role of IAD to prevent otics. Using the method of sensitivity analysis, there was no dif-
intra-abdominal collections seems to be counterintuitive. It is ference in treatment effect of antibiotics in relation to wound
debatable whether IAD can lead to early detection of post-operative infection. National Institute for Health and Clinical Excellence
bleeding or bile leakage. Although this issue is considered quite (NICE) has recommended that antibiotic prophylaxis should be
important, however, most of the included studies did not address given to all clean (if the surgery involving the placement of a
the timing of which the complication had occurred. prosthesis or implant), clean-contaminated surgery and contami-
Wound infection is difficult to measure across all studies, nated surgery. Scottish Intercollegiate Guidelines Network (SIGN)
particularly when drain is involved in the wound. We are uncertain guideline recommends antibiotic prophylaxis to be administered
whether the infection arises from the wound or the drain site or for hepatobiliary surgery, upper GI surgery, colorectal surgery, and
both. None of the included studies has explicitly documented the appendicectomy (except for elective laparoscopic cholecystectomy)
details of this in their data. Furthermore, the effect of antibiotics on (Grade A Recommendation). To further augment above recom-
wound infection is difficult to establish because of overall incon- mendations, recent published systematic reviews and meta-
sistency in reporting of the use of antibiotics. Some investigators analyses found that there was statistically significant protective
routinely administered pre-operative antibiotics according to their effect of antibiotics compared with placebo (no antibiotic) in gastric
local protocol. Some authors declared used of antibiotics, but did surgery (OR 0.05, 95% CI 0.01 to 0.22), colorectal surgery (OR 0.24,
not include the choice of antibiotics, dosage and durations they 95% CI 0.13 to 0.43) and appendicectomy (0.33, 95% CI 0.29 to 0.38)
used, while some did not mention at all. but not in laparoscopic cholecystectomy (OR 0.63, 95% CI 0.30 to
This review has shown no significant benefit of using a drain 1.32) [28].
after LC. Placement of a drain neither increases the risk of post- Similar guideline has also been developed jointly by the Amer-
operative wound infection (RR 1.86, 95% CI 0.95 to 3.63; p ¼ 0.07) ican Society of Health-System Pharmacists (ASHP), the Infectious
nor decreases the risk of pneumoperitoneum-induced complica- Diseases Society of America (IDSA), the Surgical Infection Society
tions such as nausea or vomiting (RR 1.10, 95% CI 0.90 to 1.36; (SIS), and the Society for Healthcare Epidemiology of America
p ¼ 0.36) and shoulder tip pain (RR 0.99, 95% CI 0.69 to 1.40; (SHEA) [29]. Unless the patient is allergic to beta-lactam antibiotics,
p ¼ 0.93). The latter outcome is a confounding factor because a third-generation cephalosporin (e.g. cefazolin, cefoxitin, cefote-
referred shoulder tip pain can also be manifested by the gallbladder tan, ceftriaxone) is recommended as the first choice agent for
disease itself (Boas's sign) pre-operatively and other underlying biliary tract, gastro-duodenal, colorectal surgery and appendicec-
pathology such as subphrenic collection post-operatively. tomy. It is also generally felt that narrow spectrum, less expensive
The abdominal pain was lower in the drain group than no drain antibiotics should be the first choice for prophylaxis during surgery
group in the first 24 h The difference was not statistically significant and should be discontinued not later than 24 h after surgery to
when the number of people who had abdominal pain (dichotomous prevent antibiotic-associated side effect such as pseudomem-
data) was concerned (RR 0.96, CI 95% CI 0.81 to 1.14), but statisti- branous colitis due to alteration of normal flora of the GI tract.
cally significant when the severity of the pain was calculated and However it is important to note that drain placement is not the
measured by VAS (MD 10.08, 95% CI 5.24 to 14.92; p < 0.00001) at only important facet of wound infection. Other risk factors of sur-
24 h. gical site infection include (a) patient factor (e.g. malnutrition,
The operative time was reported to be longer in randomised- diabetes, obesity, tobacco use, immunosuppression); (b) operation
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94 C.S. Wong et al. / International Journal of Surgery 23 (2015) 87e96
Fig. 4. Comparison drain versus no drain in routine abdominal drainage for uncomplicated laparoscopic cholecystectomy. Outcome: Intra-abdominal collections.
Fig. 5. Comparison drain versus no drain in routine abdominal drainage for uncomplicated laparoscopic cholecystectomy. Outcome: Wound infection.
Fig. 6. Comparison drain versus no drain in routine abdominal drainage for uncomplicated laparoscopic cholecystectomy. Outcome: Nausea and/or vomiting.
Fig. 7. Comparison drain versus no drain in routine abdominal drainage for uncomplicated laparoscopic cholecystectomy. Outcome: Shoulder tip pain.
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C.S. Wong et al. / International Journal of Surgery 23 (2015) 87e96 95
Fig. 8. Comparison drain versus no drain in routine abdominal drainage for uncomplicated laparoscopic cholecystectomy. Outcome: Pain measured by VAS.
Fig. 9. Comparison drain versus no drain in routine abdominal drainage for uncomplicated laparoscopic cholecystectomy. Outcome: Operative time.
(length of operation, surgical drains, antimicrobial prophylaxis); and vital signs without solely relying on the early warning sign
and (c) operator (surgeon's skills, suturing techniques) may play a exhibited by the drain alone.
role.
4.2. Recommendations on indications for drainage
4.1. Clinical settings and judgments
Unless there are clear indications of using a drain post-
At present there is no clear benefit to advocate a routine operatively, drain should be avoided in a routine surgical practice.
The following conditions may likely be beneficial when IAD is
placement of prophylactic drainage in GI surgery. Although the
quantity and character of drain can be used to identify any inserted: (a) excessive hepatic bleeding or bile leakage intra-
operatively and (b) established intra-abdominal abscesses or
abdominal complication secondary to fluid leak (e.g. bile) or hae-
morrhage, it is not a good indicator for re-operation. Drains are not collection by imaging studies post-operatively. Drains are not
substitutes for careful haemostasis and meticulous dissection. Good
very reliable because not every biloma needs to be drained as many
settle spontaneously, and the absence of blood in the drain does not surgical technique with adequate haemostasis, the elimination of
dead space, and the use of prophylactic antibiotics obviates the
exclude post-operative bleeding. Modern imaging modalities such
as ultrasound and computed tomography (CT) scan can be need for drains in most patients.
employed to guide clinicians in making decision of re-operation in
clinically stable patients. Decision to re-operate does not only 4.3. Strengths and limitation of the review
depend on the amount of drainage but also clinical manifestation of
post-operative bleeding such as haemorrhagic shock and signs of The strengths of our study are that it addresses a question that is
abdominal peritonism. Hence, it is absolutely crucial to observe for very relevant to the practice of clinical surgery amongst the general
post-operative complications based on other clinical parameters surgeons and may potentially lead to the implementation of future
Fig. 10. Comparison drain versus no drain in routine abdominal drainage for uncomplicated laparoscopic cholecystectomy. Outcome: LOS.
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96 C.S. Wong et al. / International Journal of Surgery 23 (2015) 87e96
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