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Abdominal drainage versus no abdominal drainage for laparoscopic cholecystectomy: A systematic review with meta-analysis and trial sequential analysis
International Journal of Surgery 36 (2016) 358e368
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International Journal of Surgery journal homepage: www.journal-surgery.net
Review
Abdominal drainage versus no abdominal drainage for laparoscopic cholecystectomy: A systematic review with meta-analysis and trial sequential analysis Lv Yong*, Bai Guang Department of Surgery, The First Affiliated Hospital of JinZhou Medical University, China
h i g h l i g h t s This study has shown that routine drainage does not reduce the incidence of intra-abdominal fluid. There was no difference in the length of hospital stay. But drain use may increase resource utilization. Our study addresses a question that is relevant to the Enhanced Recovery After Surgery (ERAS) amongst the general surgeons.
a r t i c l e i n f o
a b s t r a c t
Article history: Received 19 October 2016 Received in revised form 12 November 2016 Accepted 14 November 2016 Available online 15 November 2016
The aim is to assess the benefits and harms of routine abdominal drainage in laparoscopic cholecystectomy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until August 2016. We included all randomised clinical trials comparing drainage versus no drainage after laparoscopic cholecystectomy irrespective of language and publication status. We used standard methodological procedures in accordance with the PRISMA guidelines. A total of 2398 participants were randomised to drain (1197 participants) versus ’no drain’ (1201 participants) in 16 trials included in this article. Pain 24 h after surgery was less severe in the no drain group (MD1.31; 95% CI, 0.96 to 1.65; p < 0.00001). Abdominal drainage prolonged operative time (MD 5.77 min; 95% CI 4.98 mine6.57 min; p < 0.00001) but not the length of hospital stay (MD 0.21 days; 95% CI -0.00 days to 0.42 days; p ¼ 0.05). No significant difference was present with respect to the intra-abdominal fluid, wound infection, nausea or vomit, mortality after operation. There is no significant advantage of drain placement after laparoscopic cholecystectomy. Further well designed randomized clinical trials should be carefully re-considered. © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.
Keywords: Cholecystectomy Drain Laparoscopic Meta-analysis
1. Introduction Cholelithiasis is among the most common gastrointestinal illness [1]. Approximately 80% of the cholecystectomies are performed laparoscopically [2]. Surgical drains can be open or closed. An open drain is when a catheter is left in the operative incision to allow drainage of effusion to the exterior. Closed drains can be
suction drains or passive drains. Some surgeons have routinely drained after laparoscopic cholecystectomy because of the fear of collection of bile or blood requiring open procedures [3]. The routine use of a drain after laparoscopic cholecystectomy does not promote day-procedure laparoscopic cholecystectomy as the routine use of drains may need the patient to stay overnight or
* Corresponding author. Department of Surgery, The First Affiliated Hospital of JinZhou Medical University, No.2, Section 5, People Street, JinZhou, LiaoNing, 121000, China. E-mail address: [email protected] (L. Yong). http://dx.doi.org/10.1016/j.ijsu.2016.11.083 1743-9191/© 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.
L. Yong, B. Guang / International Journal of Surgery 36 (2016) 358e368
require drain removal after discharge both of which increase the utilization of resource. In order to present more evidence to promote the Enhanced Recovery After Surgery (ERAS). We carried out a meta-analysis to assess the benefits and harms of routine abdominal drainage in laparoscopic cholecystectomy. This is an update of previous review published in 2013 [5]. 2. Objectives To assess the benefits and harms of routine abdominal drainage in laparoscopic cholecystectomy.
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3. Methods 3.1. Search strategy The systematic review and meta-analysis adhered to the Preferred Reporting Items for Systematic Reviews and MetaAnalyses (PRISMA) guidelines for meta-analyses of interventional studies [4]. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until August 2016. Using an existing search strategy [5]. Search terms are provided in Fig. 1(Search strategy).
Fig. 1. Search strategy.
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3.2. Selection criteria We included only randomised controlled trials. We included patients who have undergone laparoscopic cholecystectomy. We included only trials comparing abdominal drainage and no drainage in laparoscopic cholecystectomy. We excluded nonrandomised controlled trials, reviews, and any studies conducted in paediatric age groups. 3.3. Types of outcome measures The primary outcome of the study was to assess the incidence of intra-abdominal fluid (bile leak or biloma, bleeding or abscess) in patients who underwent laparoscopic cholecystectomy with or without the placement of the drainage. The secondary outcomes were as follow: wound infection, nausea or vomiting, pain 24 h after surgery (measured with a visual analog scale), the length of hospital stay, operating time and mortality after operation. 3.4. Data extraction Date from included studies were independently assessed by two
authors (LY and BG). Any differences in opinion were resolved through discussion. The following data were extracted for each study by using standardized extraction forms: 1. general data(author, year, study design). 2. Population characteristics (age, sex ratio, sample size) 3. Outcomes(intra-abdominal fluid, wound infection, nausea or vomiting, pain 24 hours after surgery, the length of hospital stay, operating time and mortality after operation.)
3.5. Assessment of risk of bias in included studies We independently assessed the risk of bias in the trials without masking the trial names. We followed the instructions given in the Cochrane Handbook for Systematic Reviews of Interventions [6]. we assessed the trials for the following risk of bias domains: a. Allocation sequence generation. b. Allocation concealment. c. Blinding of participants and personnel.
Fig. 2. Study flow diagram.
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Fig. 3. Characteristics of the included studies.
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d. e. f. g.
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Blinding of outcome assessors. Incomplete outcome data. Selective outcome reporting. For-profit bias
3.6. Measures of treatment effect A meta-analysis was performed using the software package Review Manager (RevMan) Version 5.3. For dichotomous variables, we calculated the risk ratio (RR) with 95% confidence interval (CI). For continuous variables, we calculated the mean difference (MD) with 95% confidence interval (CI). P < 0.05 was considered statistically significant.
we added the trials in alphabetical order according to the last name of the first author. We planned to construct the trial sequential monitoring boundaries on the basis of the required diversityadjusted information size. We applied trial sequential analysis using a required sample size calculated from an alpha error of 5%, a beta error of 20%, a control group proportion obtained from the results of our meta-analysis, and a risk ratio reduction of 20% for the binary outcomes (intraabdominal fluid, wound infection, vomit or nausea, mortality after operation) to determine whether more trials are necessary on this topic. If the trial sequential monitoring boundary is crossed before the required information size is reached, firm evidence may perhaps be established and further trials may turn out to be superfluous. On the other hand, if the boundary is not surpassed, it is most probably necessary to continue doing trials.
3.7. Assessment of heterogeneity 4. Results We explored heterogeneity by the Chi2 test, with significance set at a P value of 0.10, and measured the quantity of heterogeneity by the I2 statistic. A significant heterogeneity presents when I2 > 50% [7]. The fixed-effect model was used if there was no significant heterogeneity across studies. If significant heterogeneity is present; the random-effects were applied. 3.8. Assessment of reporting biases We planned to use a funnel plot to explore bias in the presence of at least 10 trials for the specific outcome [8]. 3.9. Sensitivity analysis We performed sensitivity analyses to investigate the effect on outcome by: 1. Changing between a fixed-effect model and a random-effects model. 2. Changing between risk ratios (RR), risk differences (RD), and odds ratios (OR) for dichotomous outcomes. 3. Changing between mean differences (MD) and standardized mean differences (SMD) for continuous outcomes.
3.10. Trial sequential analysis We used the trial sequential analysis to control for random errors due to sparse data and repetitive testing of the accumulating data for binary outcomes. We added the trials according to the year of publication, and if more than one trial was published in a year,
In total, 16 studies were included in the meta analysis with a total of 2388 patients. The reference flow is show in Fig. 2 (Study flow diagram). A summary of randomised controlled trials comparing characteristics and outcomes of drains versus no drain was showed in Fig. 3(Characteristics of the included studies). In four studies, a closed suction drain was used(Kim 2015 [9]; Park 2015 [10]; Picchio 2012 [11]; Hawasli 1994). In four studies, a nonsuction drain was used(Nursal 2003 [12], Mrozowicz 2006 [13], Georgiou 2011 [14], Lucarelli 2012 [15]). In four studies, an open drain was used(Uchimaya 2007 [16], Tzovaras 2009 [17], El-labban 2012 [18], Sharma 2016 [19]). In four studies, subhepatic drain was used but details were not provided(Nomdedeu 1997 [20],Thiebe 1994 [21], Capitanich 2005 [22], Shamim 2013 [23]). 4.1. Risk of bias in included studies The summary of the risk of bias in each domain and the risk of bias in each domain in each trial are shown in Fig. 4 and Fig. 5. 4.2. Effects of interventions 4.2.1. Intra-abdominal fluid Eight trials reported this outcome. There was no significant difference between the drain group (56/728) and the ’no drain’ group (48/721) in the patients who developed intra-abdominal fluid in the eight trials with 1449 participants (RR1.08; 95% CI 0.78 to 1.49) (Fig. 6). The result did not change when we adopted the random-effects model. The result did not change when we calculated the risk differences (RD) and odds ratios (OR) for dichotomous outcomes. Trial sequential analysis revealed that the
Fig. 4. Risk of bias graph.
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diversity-adjusted required information size (DARIS) was calculated to 10068 patients, based on the proportion of patients in the control group with the outcome of 5.28%. After accruing a total of 1449 participants in eight trials, only 14.4% of the DARIS has been reached. The cumulative Z-curve does not cross the trial sequential monitoring boundaries or the conventional boundaries (Fig. 13). 4.2.2. Wound infection Nine trials reported this outcome. There was no significant difference between the drain group (28/553) and the ’no drain’ group (15/546) in the patients who developed wound infection events in the nine trials with 1099 participants (RR1.81; 95% CI 0.99 to 3.29) (Fig. 7). The result did not change when we adopted the random-effects model. The result did not change when we calculated the risk differences (RD) and odds ratios (OR) for dichotomous outcomes. There was no evidence of heterogeneity. Trial sequential analysis revealed that the diversity-adjusted required information size (DARIS) was calculated to 25528 patients, based on the proportion of patients in the control group with the outcome of 2.16%. After accruing a total of 1099 participants in nine trials, only 4.3% of the DARIS has been reached. Accordingly, the trial sequential analysis does not show the required information size and the trial sequential monitoring boundaries. As shown, the conventional statistical boundaries have also not been crossed by the cumulative Z-curve (Fig. 14). 4.2.3. Vomit or nausea Nine trials reported this outcome. There was no significant difference between the drain group (125/563) and the ’no drain’ group (100/539) in the patients who developed vomit or nausea in the nine trials with 1102 participants (RR1.15; 95% CI 0.94 to 1.41) (Fig. 8). The result did not change when we adopted the randomeffects model. The result did not change when we calculated the risk differences (RD) and odds ratios (OR) for dichotomous outcomes. Trial sequential analysis revealed that The diversityadjusted required information size (DARIS) was calculated to 3138 patients, based on the proportion of patients in the control group with the outcome of 14.8%.After accruing a total of 1102 participants in nine trials, only 35.1% of the DARIS has been reached. The cumulative Z-curve does not cross trial sequential monitoring boundaries, and required information size was not reached (Fig. 15). 4.2.4. Pain 24 h after surgery Seven trials reported this outcome. Each study used a 10-point visual analog scale. Pain 24 h after surgery was less severe in the no drain group (MD1.31; 95% CI, 0.96 to 1.65; p < 0.00001) (Fig. 9). Heterogeneity was statistically significant (I2 ¼ 94%, P < 0 .00001). So the random-effects were applied. The pain was measured by visual analogue scale (VAS). The result did not change when we adopted the fixed-effect model. The result did not change when we calculated the SMD for continuous outcomes. 4.2.5. Mortality after operation Twelve trials reported this outcome. There was no significant difference between the drain group (1/964) and the ’no drain’ group (2/970) (RR0.41; 95% CI 0.04 to 4.37) in mortality after operation in the twelve trials with 1924 participants(Fig. 10). The result did not change when we adopted the random-effects model. The result did not change when we calculated the risk differences (RD) and odds ratios (OR) for dichotomous outcomes. Trial sequential analysis revealed that the diversity-adjusted required information size (DARIS) was calculated to 352564 patients, based on the proportion of patients in the control group with the outcome of 0.16%. After accruing a total of 1934 participants in
Fig. 5. Risk of bias summary.
twelve trials, only 0.55% of the DARIS has been reached. The cumulative Z-curve does not cross trial sequential monitoring boundaries, and required information size was not reached (Fig. 16).
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Fig. 6. ‘Drain’ versus ‘No Drain’, outcome: 1.1 Intra-abdominal fluid.
Fig. 7. ‘Drain’ versus ‘No Drain’, outcome: 1.2 Wound infection.
Fig. 8. ‘Drain’ versus ‘No Drain’, outcome: 1.3 Vomit or nausea.
Fig. 9. ‘Drain’ versus ‘No Drain’, outcome: 1.4 Pain 24 h after surgery.
4.2.6. Operating time Nine trials reported this outcome. The operating time was significantly longer in the drain group than the ’no drain’ group (nine trials; 1533 participants; MD 5.77 min; 95% CI 4.98 mine6.57 min) (Fig. 11). The result did not change when we adopted the random-effects model. The result did not change when we calculated the SMD for continuous outcomes. 4.2.7. The length of hospital stay Six trials reported this outcome. There was no significant
difference in the length of hospital stay between the two groups (six trials; 642 participants; MD 0.21 days; 95% CI -0.00 days to 0.42 days) (Fig. 12). The result did not change when we calculated the SMD for continuous outcomes. 4.3. Reporting bias Given the small number of studies per outcome, no funnel plots were generated to test for reporting bias. Future updates of this review will include funnel plots if sufficient studies are available [6].
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Fig. 10. ‘Drain’ versus ‘No Drain’, outcome: 1.5 Mortality after operation.
Fig. 11. ‘Drain’ versus ‘No Drain’, outcome: 1.6 Operating time.
Fig. 12. ‘Drain’ versus ‘No Drain’, outcome: 1.7 The length of hospital stay.
5. Discussion This meta-analysis has shown no significant advantage of using the drainage after laparoscopic cholecystectomy. The rationale of the sub-hepatic drainage after cholecystectomy is the early detection of bile leak and of any unsuspected hemorrhage and the possibility to evacuate abdominal fluid collections without the need for more invasive procedures. Moreover, the drainage may let CO2 escape, thereby decreasing the peritoneal irritation (there is no hard evidence to support this hypothesis.) [24]. However, this study has shown that routine drainage does not reduce the incidence of intra-abdominal fluid (RR1.08, 95% CI 0.78 to 1.49; p ¼ 0.5). In fact, the total number of abdominal fluid was higher in the drain group compared to the ‘no drain’ group. Therefore, intra-abdominal drainage seems of little practical value to prevent intraabdominal fluid. The absence of significant difference between the two groups may be due to lack of effective evidence. Although, the study has shown that drainage does not increase the incidence of wound infection (RR1.81; 95% CI 0.99 to 3.29). It is difficult to measure wound infection across all studies. We are uncertain whether the infection origin from the wound or the drain site or both. None of the detail data was documented in the including studies.
Placement of a drain does not decrease the risk of complications such as vomit or nausea (RR 1.15, 95% CI 0.94 to 1.41; p ¼ 0.16). We analyzed only studies using a visual analog scale (Postoperative pain was assessed using a 10-point visual analog scale). Moreover, we reported postoperative pain at a fixed time: 24 h after surgery. Although the heterogeneity was statistically significant. However, the overall outcomes clearly indicated a significant decrease in the severity of pain when drainage was not used. The irritation of the peritoneum and skin at the entry point of the drains may increase pain in patients. There was no significant difference in the mortality after operation between the drain group and the ‘no drain’ group (RR0.41; 95% CI 0.04 to 4.37). Since there were no events in eleven of the twelve trials. The operative time was significantly longer in the drain group (MD5.77 min, 95% CI 4.98 to 6.57; p < 0.00001). However, the difference was only 6 min, which does not seem to be clinically significant. There was no difference in the length of hospital stay between the two groups (MD 0.21 days; 95% CI -0.00 days to 0.42 days; p ¼ 0.05). The P-value of hospital stay are marginally significant. It is not fully reliable because many factors are not directly related to the operation (eg, patient's motivation, external uncontrolled advice, and insurance coverage for disability) and may influence the results in different studies. Drain use may increase
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Fig. 13. Trial sequential analysis of Intra-abdominal fluid. The diversity-adjusted required information size (DARIS) was calculated to 10068 patients, based on the proportion of patients in the control group with the outcome of 5.28%, a relative risk reduction of 20%, an alpha of 5%, a beta of 20%, and a diversity of 0%. After accruing a total of 1449 participants in eight trials, only 14.4% of the DARIS has been reached. The cumulative Z-curve does not cross the trial sequential monitoring boundaries or the conventional boundaries.
Fig. 14. Trial sequential analysis of wound infection. The diversity-adjusted required information size (DARIS) was calculated to 25528 patients, based on the proportion of patients in the control group with the outcome of 2.16%, a relative risk reduction of 20%, an alpha of 5%, a beta of 20%, and a diversity of 0%. After accruing a total of 1099 participants in nine trials, only 4.3% of the DARIS has been reached. Accordingly, the trial sequential analysis does not show the required information size and the trial sequential monitoring boundaries. As shown, the conventional statistical boundaries have also not been crossed by the cumulative Z-curve.
resource utilization. The patient has to either stay in hospital until the drainage is removed or has to go home with the drainage and visit the hospital again to remove the drainage. So the drainage does not appear to be justified. The limitations of this meta-analysis are that most of the trials included only adult patients undergoing elective laparoscopic cholecystectomy. So, this meta-analysis is applied only to adult patients undergoing elective laparoscopic cholecystectomy.
However, we must put forward that there is no compelling evidence to suggest that the rationale for drain use is different in children. The search of literature was sufficient. But some trials not being reported since the lack of benefit of drainage. These articles can not be included. It is unlikely to affect our result. The strengths of our study are that it addresses a question that is very relevant to the Enhanced Recovery After Surgery (ERAS) amongst the general surgeons. Generally speaking, the evidence from this meta-analysis
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Fig. 15. Trial sequential analysis of vomit or nausea. The diversity-adjusted required information size (DARIS) was calculated to 3138 patients, based on the proportion of patients in the control group with the outcome of 14,8%, a relative risk reduction of 20%, an alpha of 5%, a beta of 20%, and a diversity of 0%. After accruing a total of 1102 participants in nine trials, only 35.1% of the DARIS has been reached. The cumulative Z-curve does not cross trial sequential monitoring boundaries, and required information size was not reached.
Fig. 16. Trial sequential analysis of mortality. The diversity-adjusted required information size (DARIS) was calculated to 352564 patients, based on the proportion of patients in the control group with the outcome of 0.16%, a relative risk reduction of 20%, an alpha of 5%, a beta of 20%, and a diversity of 0%. After accruing a total of 1934 participants in twelve trials, only 0.55% of the DARIS has been reached. The cumulative Z-curve does not cross trial sequential monitoring boundaries, and required information size was not reached.
can be regarded as the best available evidence on this topic.
included in this meta-analysis. However, a claim should be made that high-quality randomized trials should be performed.
5.1. Agreements and disagreements with other studies or reviews 5.2. Implications for research This updated review is largely in agreement with the conclusions of the previously published meta-analysis that drain use seems unnecessary for laparoscopic cholecystectomy and may even be harmful. With respect to the previous meta-analysis, the main strength of our meta-analysis is more recent new trials have been
The necessity of drain placement in laparoscopic cholecystectomy for other reasons (such as laparoscopic cholecystectomy combined with bile duct exploration and T-tube drainage, laparoscopic cholecystectomy combined with bile duct exploration and
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primary closure) and in surgery for other gallbladder diseases (such as perforated gallbladder, gallbladder polyps) is worthy of study in the future. Further adequately powered trials with low risk of bias are necessary. Further research is needed to provide more robust evidence. Trials need to be conducted and adhere to the CONSORT guidelines for reporting future clinical trials [25]. Currently, there is no evidence to support the use of drains after laparoscopic cholecystectomy.
[7] [8] [9]
[10]
Ethical approval None. Sources of funding No sources of support supplied. Author contribution Lv Yong was responsible for the study design, data analysis and writing. Bai Guang was responsible for the data collections. Conflicts of interest
[11]
[12]
[13]
[14]
[15]
[16]
No potential conflicts of interest were disclosed. [17]
Guarantor 1. Lv Yong, Email:[email protected]. 2Bai Guang, [email protected].
[18]
[19]
Research Registration Unique Identifying Number (UIN) [20]
reviewregistry138. References [1] C.M. Townsend, Sabiston Textbook of Surgery, 18ed, Elsevier, Noida, 2009, 2: 1558. [2] M. Ballal, G. David, S. Willmott, D.J. Corless, M. Deakin, J.P. Slavin, Conversion after laparoscopic cholecystectomy in England, Surg. Endosc. 23 (10) (2009) 2338e2344. [3] A. Hawasli, To drain or not to drain in laparoscopic cholecystectomy: rationale and technique, Surg. Laparosc. Endosc. 2 (2) (1992) 128e130. [4] A. Liberati, D.G. Altman, J. Tetzlaff, et al., The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions, PLoS Med. 6 (2009) e1000100. [5] K.S. Gurusamy, R. Koti, B.R. Davidson, Routine abdominal drainage versus no abdominal drainage for uncomplicated laparoscopic cholecystectomy, Cochrane Database Syst. Rev. 9 (2013) CD006004. [6] J.P.T. Higgins, S. Green (Eds.), Cochrane Handbook for Systematic Reviews of
[21] [22]
[23]
[24]
[25]
Interventions Version 5.1.0 [updated March 2011], The Cochrane Colloboration, 2011. Available from:www.cochrane-handbook.org. J.P.T. Higgins, S.G. Thompson, Quantifying heterogeneity in a meta-analysis, Statistics Med. 21 (11) (2002) 1539e1558. P. Macaskill, S.D. Walter, L. Irwig, A comparison of methods to detect publication bias in meta-analysis, Statistics Med. 20 (4) (2001) 641e654. E.Y. Kim, S.H. Lee, J.S. Lee, Y.C. Yoon, S.K. Park, H.J. Choi, D.D. Yoo, T.H. Hong, Is routine drain insertion after laparoscopic cholecystectomy for acute cholecystitis beneficial? A multicenter, prospective randomized controlled trial, J. Hepatobiliary Pancreat. Sci. 22 (7) (2015) 551e557. J.S. Park, J.H. Kim, J.K. Kim, D.S. Yoon, The role of abdominal drainage to prevent of intra-abdominal complications after laparoscopic cholecystectomy for acute cholecystitis: prospective randomized trial, Surg. Endosc. 29 (2) (2014) 453e457. M. Picchio, F. De Angelis, S. Zazza, A.D. Filippo, R. Mancini, G. Pattaro, et al., Drain after elective laparoscopic cholecystectomy. A randomized multicentre controlled trial, Surg. Endosc. 26 (10) (2012) 2817e2822. T.Z. Nursal, S. Yildirim, A. Tarim, T. Noyan, P. Poyraz, N. Tuna, et al., Effect of drainage on postoperative nausea, vomiting, and pain after laparoscopic cholecystectomy, Langenbecks Archive Surg. 388 (2) (2003) 95e100. A. Mrozowicz, P. Rucinski, W.P. Polkowski, Routine drainage of the subhepatic area after laparoscopic cholecystectomy. Prospective, controlled study with random patient selection, Pol. Przeglad Chir. 78 (5) (2006) 597e609. C. Georgiou, N. Demetriou, T. Pallaris, T. Theodosopoulos, K. Katsouyanni, G. Polymeneas, Is the routine use of drainage after elective laparoscopic cholecystectomy justified? A randomized trial, J. Laparoendosc. Adv. Surg. Tech. Part A 21 (2) (2011) 119e123. P. Lucarelli, M. Picchio, J. Martellucci, F. Angelis, A. Filippo, F. Stipa, et al., Drain after laparoscopic cholecystectomy for acute calculous cholecystitis. A pilot randomized study, Indian J. Surg. 74 (6) (2012) 1e5. K. Uchiyama, M. Tani, M. Kawai, H. Terasawa, T. Hama, H. Yamaue, Clinical significance of drainage tube insertion in laparoscopic cholecystectomy: a prospective randomized controlled trial, J. Hepato-Biliary-Pancreatic Surg. 14 (6) (2007) 551e556. G. Tzovaras, P. Liakou, F. Fafoulakis, I. Baloyiannis, D. Zacharoulis, C. Hatzitheofilou, Is there a role for drain use in elective laparoscopic cholecystectomy? A controlled randomized trial, Am. J. Surg. 197 (6) (2009) 759e763. G. El-Labban, E. Hokkam, M. El-Labban, A. Saber, K. Heissam, S. El-Kammash, Laparoscopic elective cholecystectomy with and without drain: a controlled randomised trial, J. Minimal Access Surg. 8 (3) (2012) 90e92. A. Sharma, S.N. Gupta, Drainage versus no drainage after elective laparoscopic cholecystectomy, Kathmandu Univ. Med. J. 14 (53) (2016) 69e72. J. Nomdedeu, J.L. Salvador, R. Piqueras, J. Escrig, R. Garcia, The systematic use of drainage in laparoscopic cholecystectomy. A prospective study [Aspectos de la utilizacion sistematica de drenajes en la colecistectomia laparoscopica. Estudio prospectivo], Cirugia Espanola 61 (4) (1997) 254e257. U. Thiebe, A. Eggert, Drainage after laparoscopic cholecystectomy, Minimal Invasive Chir. 3 (1994) 90e92. P. Capitanich, U.L. Segundo, P. Malizia, J. Herrera, M.L. Iovaldi, Usefulness of prophylactic drainage in laparoscopic cholecystectomy. Randomized prospective report, Prensa Medica Argent. 92 (9) (2005) 623e627. M. Shamim, Routine sub-hepatic drainage versus No drainage after laparoscopic cholecystectomy: open, randomized, Clin. Trial. Indian J. Surg. 75 (1) (2013) 22e27. ski, R.M. Herman, Low-pressure pneumoperitoneum combined M. Barczyn with intraperitoneal saline washout for reduction of pain after laparoscopic cholecystectomy: a prospective randomized study, Surg. Endosc. 18 (2004) 1368e1373. K.F. Schulz, D.G. Altman, D. Moher, CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials, BMC Med. 8 (1) (2010) 18.
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Review
Abdominal drainage versus no abdominal drainage for laparoscopic cholecystectomy: A systematic review with meta-analysis and trial sequential analysis Lv Yong*, Bai Guang Department of Surgery, The First Affiliated Hospital of JinZhou Medical University, China
h i g h l i g h t s This study has shown that routine drainage does not reduce the incidence of intra-abdominal fluid. There was no difference in the length of hospital stay. But drain use may increase resource utilization. Our study addresses a question that is relevant to the Enhanced Recovery After Surgery (ERAS) amongst the general surgeons.
a r t i c l e i n f o
a b s t r a c t
Article history: Received 19 October 2016 Received in revised form 12 November 2016 Accepted 14 November 2016 Available online 15 November 2016
The aim is to assess the benefits and harms of routine abdominal drainage in laparoscopic cholecystectomy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until August 2016. We included all randomised clinical trials comparing drainage versus no drainage after laparoscopic cholecystectomy irrespective of language and publication status. We used standard methodological procedures in accordance with the PRISMA guidelines. A total of 2398 participants were randomised to drain (1197 participants) versus ’no drain’ (1201 participants) in 16 trials included in this article. Pain 24 h after surgery was less severe in the no drain group (MD1.31; 95% CI, 0.96 to 1.65; p < 0.00001). Abdominal drainage prolonged operative time (MD 5.77 min; 95% CI 4.98 mine6.57 min; p < 0.00001) but not the length of hospital stay (MD 0.21 days; 95% CI -0.00 days to 0.42 days; p ¼ 0.05). No significant difference was present with respect to the intra-abdominal fluid, wound infection, nausea or vomit, mortality after operation. There is no significant advantage of drain placement after laparoscopic cholecystectomy. Further well designed randomized clinical trials should be carefully re-considered. © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.
Keywords: Cholecystectomy Drain Laparoscopic Meta-analysis
1. Introduction Cholelithiasis is among the most common gastrointestinal illness [1]. Approximately 80% of the cholecystectomies are performed laparoscopically [2]. Surgical drains can be open or closed. An open drain is when a catheter is left in the operative incision to allow drainage of effusion to the exterior. Closed drains can be
suction drains or passive drains. Some surgeons have routinely drained after laparoscopic cholecystectomy because of the fear of collection of bile or blood requiring open procedures [3]. The routine use of a drain after laparoscopic cholecystectomy does not promote day-procedure laparoscopic cholecystectomy as the routine use of drains may need the patient to stay overnight or
* Corresponding author. Department of Surgery, The First Affiliated Hospital of JinZhou Medical University, No.2, Section 5, People Street, JinZhou, LiaoNing, 121000, China. E-mail address: [email protected] (L. Yong). http://dx.doi.org/10.1016/j.ijsu.2016.11.083 1743-9191/© 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.
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require drain removal after discharge both of which increase the utilization of resource. In order to present more evidence to promote the Enhanced Recovery After Surgery (ERAS). We carried out a meta-analysis to assess the benefits and harms of routine abdominal drainage in laparoscopic cholecystectomy. This is an update of previous review published in 2013 [5]. 2. Objectives To assess the benefits and harms of routine abdominal drainage in laparoscopic cholecystectomy.
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3. Methods 3.1. Search strategy The systematic review and meta-analysis adhered to the Preferred Reporting Items for Systematic Reviews and MetaAnalyses (PRISMA) guidelines for meta-analyses of interventional studies [4]. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until August 2016. Using an existing search strategy [5]. Search terms are provided in Fig. 1(Search strategy).
Fig. 1. Search strategy.
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3.2. Selection criteria We included only randomised controlled trials. We included patients who have undergone laparoscopic cholecystectomy. We included only trials comparing abdominal drainage and no drainage in laparoscopic cholecystectomy. We excluded nonrandomised controlled trials, reviews, and any studies conducted in paediatric age groups. 3.3. Types of outcome measures The primary outcome of the study was to assess the incidence of intra-abdominal fluid (bile leak or biloma, bleeding or abscess) in patients who underwent laparoscopic cholecystectomy with or without the placement of the drainage. The secondary outcomes were as follow: wound infection, nausea or vomiting, pain 24 h after surgery (measured with a visual analog scale), the length of hospital stay, operating time and mortality after operation. 3.4. Data extraction Date from included studies were independently assessed by two
authors (LY and BG). Any differences in opinion were resolved through discussion. The following data were extracted for each study by using standardized extraction forms: 1. general data(author, year, study design). 2. Population characteristics (age, sex ratio, sample size) 3. Outcomes(intra-abdominal fluid, wound infection, nausea or vomiting, pain 24 hours after surgery, the length of hospital stay, operating time and mortality after operation.)
3.5. Assessment of risk of bias in included studies We independently assessed the risk of bias in the trials without masking the trial names. We followed the instructions given in the Cochrane Handbook for Systematic Reviews of Interventions [6]. we assessed the trials for the following risk of bias domains: a. Allocation sequence generation. b. Allocation concealment. c. Blinding of participants and personnel.
Fig. 2. Study flow diagram.
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Fig. 3. Characteristics of the included studies.
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d. e. f. g.
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Blinding of outcome assessors. Incomplete outcome data. Selective outcome reporting. For-profit bias
3.6. Measures of treatment effect A meta-analysis was performed using the software package Review Manager (RevMan) Version 5.3. For dichotomous variables, we calculated the risk ratio (RR) with 95% confidence interval (CI). For continuous variables, we calculated the mean difference (MD) with 95% confidence interval (CI). P < 0.05 was considered statistically significant.
we added the trials in alphabetical order according to the last name of the first author. We planned to construct the trial sequential monitoring boundaries on the basis of the required diversityadjusted information size. We applied trial sequential analysis using a required sample size calculated from an alpha error of 5%, a beta error of 20%, a control group proportion obtained from the results of our meta-analysis, and a risk ratio reduction of 20% for the binary outcomes (intraabdominal fluid, wound infection, vomit or nausea, mortality after operation) to determine whether more trials are necessary on this topic. If the trial sequential monitoring boundary is crossed before the required information size is reached, firm evidence may perhaps be established and further trials may turn out to be superfluous. On the other hand, if the boundary is not surpassed, it is most probably necessary to continue doing trials.
3.7. Assessment of heterogeneity 4. Results We explored heterogeneity by the Chi2 test, with significance set at a P value of 0.10, and measured the quantity of heterogeneity by the I2 statistic. A significant heterogeneity presents when I2 > 50% [7]. The fixed-effect model was used if there was no significant heterogeneity across studies. If significant heterogeneity is present; the random-effects were applied. 3.8. Assessment of reporting biases We planned to use a funnel plot to explore bias in the presence of at least 10 trials for the specific outcome [8]. 3.9. Sensitivity analysis We performed sensitivity analyses to investigate the effect on outcome by: 1. Changing between a fixed-effect model and a random-effects model. 2. Changing between risk ratios (RR), risk differences (RD), and odds ratios (OR) for dichotomous outcomes. 3. Changing between mean differences (MD) and standardized mean differences (SMD) for continuous outcomes.
3.10. Trial sequential analysis We used the trial sequential analysis to control for random errors due to sparse data and repetitive testing of the accumulating data for binary outcomes. We added the trials according to the year of publication, and if more than one trial was published in a year,
In total, 16 studies were included in the meta analysis with a total of 2388 patients. The reference flow is show in Fig. 2 (Study flow diagram). A summary of randomised controlled trials comparing characteristics and outcomes of drains versus no drain was showed in Fig. 3(Characteristics of the included studies). In four studies, a closed suction drain was used(Kim 2015 [9]; Park 2015 [10]; Picchio 2012 [11]; Hawasli 1994). In four studies, a nonsuction drain was used(Nursal 2003 [12], Mrozowicz 2006 [13], Georgiou 2011 [14], Lucarelli 2012 [15]). In four studies, an open drain was used(Uchimaya 2007 [16], Tzovaras 2009 [17], El-labban 2012 [18], Sharma 2016 [19]). In four studies, subhepatic drain was used but details were not provided(Nomdedeu 1997 [20],Thiebe 1994 [21], Capitanich 2005 [22], Shamim 2013 [23]). 4.1. Risk of bias in included studies The summary of the risk of bias in each domain and the risk of bias in each domain in each trial are shown in Fig. 4 and Fig. 5. 4.2. Effects of interventions 4.2.1. Intra-abdominal fluid Eight trials reported this outcome. There was no significant difference between the drain group (56/728) and the ’no drain’ group (48/721) in the patients who developed intra-abdominal fluid in the eight trials with 1449 participants (RR1.08; 95% CI 0.78 to 1.49) (Fig. 6). The result did not change when we adopted the random-effects model. The result did not change when we calculated the risk differences (RD) and odds ratios (OR) for dichotomous outcomes. Trial sequential analysis revealed that the
Fig. 4. Risk of bias graph.
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diversity-adjusted required information size (DARIS) was calculated to 10068 patients, based on the proportion of patients in the control group with the outcome of 5.28%. After accruing a total of 1449 participants in eight trials, only 14.4% of the DARIS has been reached. The cumulative Z-curve does not cross the trial sequential monitoring boundaries or the conventional boundaries (Fig. 13). 4.2.2. Wound infection Nine trials reported this outcome. There was no significant difference between the drain group (28/553) and the ’no drain’ group (15/546) in the patients who developed wound infection events in the nine trials with 1099 participants (RR1.81; 95% CI 0.99 to 3.29) (Fig. 7). The result did not change when we adopted the random-effects model. The result did not change when we calculated the risk differences (RD) and odds ratios (OR) for dichotomous outcomes. There was no evidence of heterogeneity. Trial sequential analysis revealed that the diversity-adjusted required information size (DARIS) was calculated to 25528 patients, based on the proportion of patients in the control group with the outcome of 2.16%. After accruing a total of 1099 participants in nine trials, only 4.3% of the DARIS has been reached. Accordingly, the trial sequential analysis does not show the required information size and the trial sequential monitoring boundaries. As shown, the conventional statistical boundaries have also not been crossed by the cumulative Z-curve (Fig. 14). 4.2.3. Vomit or nausea Nine trials reported this outcome. There was no significant difference between the drain group (125/563) and the ’no drain’ group (100/539) in the patients who developed vomit or nausea in the nine trials with 1102 participants (RR1.15; 95% CI 0.94 to 1.41) (Fig. 8). The result did not change when we adopted the randomeffects model. The result did not change when we calculated the risk differences (RD) and odds ratios (OR) for dichotomous outcomes. Trial sequential analysis revealed that The diversityadjusted required information size (DARIS) was calculated to 3138 patients, based on the proportion of patients in the control group with the outcome of 14.8%.After accruing a total of 1102 participants in nine trials, only 35.1% of the DARIS has been reached. The cumulative Z-curve does not cross trial sequential monitoring boundaries, and required information size was not reached (Fig. 15). 4.2.4. Pain 24 h after surgery Seven trials reported this outcome. Each study used a 10-point visual analog scale. Pain 24 h after surgery was less severe in the no drain group (MD1.31; 95% CI, 0.96 to 1.65; p < 0.00001) (Fig. 9). Heterogeneity was statistically significant (I2 ¼ 94%, P < 0 .00001). So the random-effects were applied. The pain was measured by visual analogue scale (VAS). The result did not change when we adopted the fixed-effect model. The result did not change when we calculated the SMD for continuous outcomes. 4.2.5. Mortality after operation Twelve trials reported this outcome. There was no significant difference between the drain group (1/964) and the ’no drain’ group (2/970) (RR0.41; 95% CI 0.04 to 4.37) in mortality after operation in the twelve trials with 1924 participants(Fig. 10). The result did not change when we adopted the random-effects model. The result did not change when we calculated the risk differences (RD) and odds ratios (OR) for dichotomous outcomes. Trial sequential analysis revealed that the diversity-adjusted required information size (DARIS) was calculated to 352564 patients, based on the proportion of patients in the control group with the outcome of 0.16%. After accruing a total of 1934 participants in
Fig. 5. Risk of bias summary.
twelve trials, only 0.55% of the DARIS has been reached. The cumulative Z-curve does not cross trial sequential monitoring boundaries, and required information size was not reached (Fig. 16).
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Fig. 6. ‘Drain’ versus ‘No Drain’, outcome: 1.1 Intra-abdominal fluid.
Fig. 7. ‘Drain’ versus ‘No Drain’, outcome: 1.2 Wound infection.
Fig. 8. ‘Drain’ versus ‘No Drain’, outcome: 1.3 Vomit or nausea.
Fig. 9. ‘Drain’ versus ‘No Drain’, outcome: 1.4 Pain 24 h after surgery.
4.2.6. Operating time Nine trials reported this outcome. The operating time was significantly longer in the drain group than the ’no drain’ group (nine trials; 1533 participants; MD 5.77 min; 95% CI 4.98 mine6.57 min) (Fig. 11). The result did not change when we adopted the random-effects model. The result did not change when we calculated the SMD for continuous outcomes. 4.2.7. The length of hospital stay Six trials reported this outcome. There was no significant
difference in the length of hospital stay between the two groups (six trials; 642 participants; MD 0.21 days; 95% CI -0.00 days to 0.42 days) (Fig. 12). The result did not change when we calculated the SMD for continuous outcomes. 4.3. Reporting bias Given the small number of studies per outcome, no funnel plots were generated to test for reporting bias. Future updates of this review will include funnel plots if sufficient studies are available [6].
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Fig. 10. ‘Drain’ versus ‘No Drain’, outcome: 1.5 Mortality after operation.
Fig. 11. ‘Drain’ versus ‘No Drain’, outcome: 1.6 Operating time.
Fig. 12. ‘Drain’ versus ‘No Drain’, outcome: 1.7 The length of hospital stay.
5. Discussion This meta-analysis has shown no significant advantage of using the drainage after laparoscopic cholecystectomy. The rationale of the sub-hepatic drainage after cholecystectomy is the early detection of bile leak and of any unsuspected hemorrhage and the possibility to evacuate abdominal fluid collections without the need for more invasive procedures. Moreover, the drainage may let CO2 escape, thereby decreasing the peritoneal irritation (there is no hard evidence to support this hypothesis.) [24]. However, this study has shown that routine drainage does not reduce the incidence of intra-abdominal fluid (RR1.08, 95% CI 0.78 to 1.49; p ¼ 0.5). In fact, the total number of abdominal fluid was higher in the drain group compared to the ‘no drain’ group. Therefore, intra-abdominal drainage seems of little practical value to prevent intraabdominal fluid. The absence of significant difference between the two groups may be due to lack of effective evidence. Although, the study has shown that drainage does not increase the incidence of wound infection (RR1.81; 95% CI 0.99 to 3.29). It is difficult to measure wound infection across all studies. We are uncertain whether the infection origin from the wound or the drain site or both. None of the detail data was documented in the including studies.
Placement of a drain does not decrease the risk of complications such as vomit or nausea (RR 1.15, 95% CI 0.94 to 1.41; p ¼ 0.16). We analyzed only studies using a visual analog scale (Postoperative pain was assessed using a 10-point visual analog scale). Moreover, we reported postoperative pain at a fixed time: 24 h after surgery. Although the heterogeneity was statistically significant. However, the overall outcomes clearly indicated a significant decrease in the severity of pain when drainage was not used. The irritation of the peritoneum and skin at the entry point of the drains may increase pain in patients. There was no significant difference in the mortality after operation between the drain group and the ‘no drain’ group (RR0.41; 95% CI 0.04 to 4.37). Since there were no events in eleven of the twelve trials. The operative time was significantly longer in the drain group (MD5.77 min, 95% CI 4.98 to 6.57; p < 0.00001). However, the difference was only 6 min, which does not seem to be clinically significant. There was no difference in the length of hospital stay between the two groups (MD 0.21 days; 95% CI -0.00 days to 0.42 days; p ¼ 0.05). The P-value of hospital stay are marginally significant. It is not fully reliable because many factors are not directly related to the operation (eg, patient's motivation, external uncontrolled advice, and insurance coverage for disability) and may influence the results in different studies. Drain use may increase
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Fig. 13. Trial sequential analysis of Intra-abdominal fluid. The diversity-adjusted required information size (DARIS) was calculated to 10068 patients, based on the proportion of patients in the control group with the outcome of 5.28%, a relative risk reduction of 20%, an alpha of 5%, a beta of 20%, and a diversity of 0%. After accruing a total of 1449 participants in eight trials, only 14.4% of the DARIS has been reached. The cumulative Z-curve does not cross the trial sequential monitoring boundaries or the conventional boundaries.
Fig. 14. Trial sequential analysis of wound infection. The diversity-adjusted required information size (DARIS) was calculated to 25528 patients, based on the proportion of patients in the control group with the outcome of 2.16%, a relative risk reduction of 20%, an alpha of 5%, a beta of 20%, and a diversity of 0%. After accruing a total of 1099 participants in nine trials, only 4.3% of the DARIS has been reached. Accordingly, the trial sequential analysis does not show the required information size and the trial sequential monitoring boundaries. As shown, the conventional statistical boundaries have also not been crossed by the cumulative Z-curve.
resource utilization. The patient has to either stay in hospital until the drainage is removed or has to go home with the drainage and visit the hospital again to remove the drainage. So the drainage does not appear to be justified. The limitations of this meta-analysis are that most of the trials included only adult patients undergoing elective laparoscopic cholecystectomy. So, this meta-analysis is applied only to adult patients undergoing elective laparoscopic cholecystectomy.
However, we must put forward that there is no compelling evidence to suggest that the rationale for drain use is different in children. The search of literature was sufficient. But some trials not being reported since the lack of benefit of drainage. These articles can not be included. It is unlikely to affect our result. The strengths of our study are that it addresses a question that is very relevant to the Enhanced Recovery After Surgery (ERAS) amongst the general surgeons. Generally speaking, the evidence from this meta-analysis
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Fig. 15. Trial sequential analysis of vomit or nausea. The diversity-adjusted required information size (DARIS) was calculated to 3138 patients, based on the proportion of patients in the control group with the outcome of 14,8%, a relative risk reduction of 20%, an alpha of 5%, a beta of 20%, and a diversity of 0%. After accruing a total of 1102 participants in nine trials, only 35.1% of the DARIS has been reached. The cumulative Z-curve does not cross trial sequential monitoring boundaries, and required information size was not reached.
Fig. 16. Trial sequential analysis of mortality. The diversity-adjusted required information size (DARIS) was calculated to 352564 patients, based on the proportion of patients in the control group with the outcome of 0.16%, a relative risk reduction of 20%, an alpha of 5%, a beta of 20%, and a diversity of 0%. After accruing a total of 1934 participants in twelve trials, only 0.55% of the DARIS has been reached. The cumulative Z-curve does not cross trial sequential monitoring boundaries, and required information size was not reached.
can be regarded as the best available evidence on this topic.
included in this meta-analysis. However, a claim should be made that high-quality randomized trials should be performed.
5.1. Agreements and disagreements with other studies or reviews 5.2. Implications for research This updated review is largely in agreement with the conclusions of the previously published meta-analysis that drain use seems unnecessary for laparoscopic cholecystectomy and may even be harmful. With respect to the previous meta-analysis, the main strength of our meta-analysis is more recent new trials have been
The necessity of drain placement in laparoscopic cholecystectomy for other reasons (such as laparoscopic cholecystectomy combined with bile duct exploration and T-tube drainage, laparoscopic cholecystectomy combined with bile duct exploration and
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primary closure) and in surgery for other gallbladder diseases (such as perforated gallbladder, gallbladder polyps) is worthy of study in the future. Further adequately powered trials with low risk of bias are necessary. Further research is needed to provide more robust evidence. Trials need to be conducted and adhere to the CONSORT guidelines for reporting future clinical trials [25]. Currently, there is no evidence to support the use of drains after laparoscopic cholecystectomy.
[7] [8] [9]
[10]
Ethical approval None. Sources of funding No sources of support supplied. Author contribution Lv Yong was responsible for the study design, data analysis and writing. Bai Guang was responsible for the data collections. Conflicts of interest
[11]
[12]
[13]
[14]
[15]
[16]
No potential conflicts of interest were disclosed. [17]
Guarantor 1. Lv Yong, Email:[email protected]. 2Bai Guang, [email protected].
[18]
[19]
Research Registration Unique Identifying Number (UIN) [20]
reviewregistry138. References [1] C.M. Townsend, Sabiston Textbook of Surgery, 18ed, Elsevier, Noida, 2009, 2: 1558. [2] M. Ballal, G. David, S. Willmott, D.J. Corless, M. Deakin, J.P. Slavin, Conversion after laparoscopic cholecystectomy in England, Surg. Endosc. 23 (10) (2009) 2338e2344. [3] A. Hawasli, To drain or not to drain in laparoscopic cholecystectomy: rationale and technique, Surg. Laparosc. Endosc. 2 (2) (1992) 128e130. [4] A. Liberati, D.G. Altman, J. Tetzlaff, et al., The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions, PLoS Med. 6 (2009) e1000100. [5] K.S. Gurusamy, R. Koti, B.R. Davidson, Routine abdominal drainage versus no abdominal drainage for uncomplicated laparoscopic cholecystectomy, Cochrane Database Syst. Rev. 9 (2013) CD006004. [6] J.P.T. Higgins, S. Green (Eds.), Cochrane Handbook for Systematic Reviews of
[21] [22]
[23]
[24]
[25]
Interventions Version 5.1.0 [updated March 2011], The Cochrane Colloboration, 2011. Available from:www.cochrane-handbook.org. J.P.T. Higgins, S.G. Thompson, Quantifying heterogeneity in a meta-analysis, Statistics Med. 21 (11) (2002) 1539e1558. P. Macaskill, S.D. Walter, L. Irwig, A comparison of methods to detect publication bias in meta-analysis, Statistics Med. 20 (4) (2001) 641e654. E.Y. Kim, S.H. Lee, J.S. Lee, Y.C. Yoon, S.K. Park, H.J. Choi, D.D. Yoo, T.H. Hong, Is routine drain insertion after laparoscopic cholecystectomy for acute cholecystitis beneficial? A multicenter, prospective randomized controlled trial, J. Hepatobiliary Pancreat. Sci. 22 (7) (2015) 551e557. J.S. Park, J.H. Kim, J.K. Kim, D.S. Yoon, The role of abdominal drainage to prevent of intra-abdominal complications after laparoscopic cholecystectomy for acute cholecystitis: prospective randomized trial, Surg. Endosc. 29 (2) (2014) 453e457. M. Picchio, F. De Angelis, S. Zazza, A.D. Filippo, R. Mancini, G. Pattaro, et al., Drain after elective laparoscopic cholecystectomy. A randomized multicentre controlled trial, Surg. Endosc. 26 (10) (2012) 2817e2822. T.Z. Nursal, S. Yildirim, A. Tarim, T. Noyan, P. Poyraz, N. Tuna, et al., Effect of drainage on postoperative nausea, vomiting, and pain after laparoscopic cholecystectomy, Langenbecks Archive Surg. 388 (2) (2003) 95e100. A. Mrozowicz, P. Rucinski, W.P. Polkowski, Routine drainage of the subhepatic area after laparoscopic cholecystectomy. Prospective, controlled study with random patient selection, Pol. Przeglad Chir. 78 (5) (2006) 597e609. C. Georgiou, N. Demetriou, T. Pallaris, T. Theodosopoulos, K. Katsouyanni, G. Polymeneas, Is the routine use of drainage after elective laparoscopic cholecystectomy justified? A randomized trial, J. Laparoendosc. Adv. Surg. Tech. Part A 21 (2) (2011) 119e123. P. Lucarelli, M. Picchio, J. Martellucci, F. Angelis, A. Filippo, F. Stipa, et al., Drain after laparoscopic cholecystectomy for acute calculous cholecystitis. A pilot randomized study, Indian J. Surg. 74 (6) (2012) 1e5. K. Uchiyama, M. Tani, M. Kawai, H. Terasawa, T. Hama, H. Yamaue, Clinical significance of drainage tube insertion in laparoscopic cholecystectomy: a prospective randomized controlled trial, J. Hepato-Biliary-Pancreatic Surg. 14 (6) (2007) 551e556. G. Tzovaras, P. Liakou, F. Fafoulakis, I. Baloyiannis, D. Zacharoulis, C. Hatzitheofilou, Is there a role for drain use in elective laparoscopic cholecystectomy? A controlled randomized trial, Am. J. Surg. 197 (6) (2009) 759e763. G. El-Labban, E. Hokkam, M. El-Labban, A. Saber, K. Heissam, S. El-Kammash, Laparoscopic elective cholecystectomy with and without drain: a controlled randomised trial, J. Minimal Access Surg. 8 (3) (2012) 90e92. A. Sharma, S.N. Gupta, Drainage versus no drainage after elective laparoscopic cholecystectomy, Kathmandu Univ. Med. J. 14 (53) (2016) 69e72. J. Nomdedeu, J.L. Salvador, R. Piqueras, J. Escrig, R. Garcia, The systematic use of drainage in laparoscopic cholecystectomy. A prospective study [Aspectos de la utilizacion sistematica de drenajes en la colecistectomia laparoscopica. Estudio prospectivo], Cirugia Espanola 61 (4) (1997) 254e257. U. Thiebe, A. Eggert, Drainage after laparoscopic cholecystectomy, Minimal Invasive Chir. 3 (1994) 90e92. P. Capitanich, U.L. Segundo, P. Malizia, J. Herrera, M.L. Iovaldi, Usefulness of prophylactic drainage in laparoscopic cholecystectomy. Randomized prospective report, Prensa Medica Argent. 92 (9) (2005) 623e627. M. Shamim, Routine sub-hepatic drainage versus No drainage after laparoscopic cholecystectomy: open, randomized, Clin. Trial. Indian J. Surg. 75 (1) (2013) 22e27. ski, R.M. Herman, Low-pressure pneumoperitoneum combined M. Barczyn with intraperitoneal saline washout for reduction of pain after laparoscopic cholecystectomy: a prospective randomized study, Surg. Endosc. 18 (2004) 1368e1373. K.F. Schulz, D.G. Altman, D. Moher, CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials, BMC Med. 8 (1) (2010) 18.