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Meta-Analysis
. 2013 Sep 3;2013(9):CD006004.
doi: 10.1002/14651858.CD006004.pub4.

Routine abdominal drainage versus no abdominal drainage for uncomplicated laparoscopic cholecystectomy

Affiliations
Meta-Analysis

Routine abdominal drainage versus no abdominal drainage for uncomplicated laparoscopic cholecystectomy

Kurinchi Selvan Gurusamy et al. Cochrane Database Syst Rev. .

Abstract

Background: Laparoscopic cholecystectomy is the main method of treatment of symptomatic gallstones. Drains are used after laparoscopic cholecystectomy to prevent abdominal collections. However, drain use may increase infective complications and delay discharge.

Objectives: The aim is to assess the benefits and harms of routine abdominal drainage in uncomplicated laparoscopic cholecystectomy.

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until February 2013.

Selection criteria: We included all randomised clinical trials comparing drainage versus no drainage after uncomplicated laparoscopic cholecystectomy irrespective of language and publication status.

Data collection and analysis: We used standard methodological procedures defined by The Cochrane Collaboration.

Main results: A total of 1831 participants were randomised to drain (915 participants) versus 'no drain' (916 participants) in 12 trials included in this review. Only two trials including 199 participants were of low risk of bias. Nine trials included patients undergoing elective laparoscopic cholecystectomy exclusively. One trial included patients undergoing laparoscopic cholecystectomy for acute cholecystitis exclusively. One trial included patients undergoing elective and emergency laparoscopic cholecystectomy, and one trial did not provide this information. The average age of participants in the trials ranged between 48 years and 63 years in the 10 trials that provided this information. The proportion of females ranged between 55.0% and 79.0% in the 11 trials that provided this information. There was no significant difference between the drain group (1/840) (adjusted proportion: 0.1%) and the 'no drain' group (2/841) (0.2%) (RR 0.41; 95% CI 0.04 to 4.37) in short-term mortality in the ten trials with 1681 participants reporting on this outcome. There was no significant difference between the drain group (7/567) (adjusted proportion: 1.1%) and the 'no drain' group (3/576) (0.5%) in the proportion of patients who developed serious adverse events in the seven trials with 1143 participants reporting on this outcome (RR 2.12; 95% CI 0.67 to 7.40) or in the number of serious adverse events in each group reported by eight trials with 1286 participants; drain group (12/646) (adjusted rate: 1.5 events per 100 participants) versus 'no drain' group (6/640) (0.9 events per 100 participants); rate ratio 1.60; 95% CI 0.66 to 3.87). There was no significant difference in the quality of life between the two groups (one trial; 93 participants; SMD 0.22; 95% CI -0.19 to 0.63). The proportion of patients who were discharged as day-procedure laparoscopic cholecystectomy seemed significantly lower in the drain group than the 'no drain' group (one trial; 68 participants; drain group (0/33) (adjusted proportion: 0.2%) versus 'no drain' group (11/35) (31.4%); RR 0.05; 95% CI 0.00 to 0.75). There was no significant difference in the length of hospital stay between the two groups (five trials; 449 participants; MD 0.22 days; 95% CI -0.06 days to 0.51 days). The operating time was significantly longer in the drain group than the 'no drain' group (seven trials; 775 participants; MD 5.00 minutes; 95% CI 2.69 minutes to 7.30 minutes). There was no significant difference in the return to normal activity and return to work between the groups in one trial involving 100 participants. This trial did not provide any information from which the standard deviation could be imputed and so the confidence intervals could not be calculated for these outcomes.

Authors' conclusions: There is currently no evidence to support the routine use of drain after laparoscopic cholecystectomy. Further well designed randomised clinical trials are necessary.

PubMed Disclaimer

Conflict of interest statement

None known.

Figures

1
1
Study flow diagram.
2
2
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
4
4
Trial sequential analysis of mortality 
 The diversity‐adjusted required information size (DARIS) was calculated to 352,564 patients, based on the proportion of patients in the control group with the outcome of 0.2%, a relative risk reduction of 20%, an alpha of 5%, a beta of 20%, and a diversity of 0%. After accruing 1651 patients in the 10 trials, only 0.47% 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, not even the conventional boundaries were crossed by the cumulative Z‐curve.
5
5
Trial sequential analysis of serious adverse events 
 The diversity‐adjusted required information size (DARIS) was calculated to 175,965 patients, based on the proportion of patients in the control group with the outcome of 0.4%, a relative risk reduction of 20%, an alpha of 5%, a beta of 20%, and a diversity of 0%. After accruing 1113 patients in the seven trials, only 0.63% 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, not even the conventional boundaries were crossed by the cumulative Z‐curve.
1.1
1.1. Analysis
Comparison 1 Drain versus 'no drain', Outcome 1 Mortality.
1.2
1.2. Analysis
Comparison 1 Drain versus 'no drain', Outcome 2 Serious adverse events (proportion of patients).
1.3
1.3. Analysis
Comparison 1 Drain versus 'no drain', Outcome 3 Serious adverse events (number).
1.4
1.4. Analysis
Comparison 1 Drain versus 'no drain', Outcome 4 Quality of life.
1.5
1.5. Analysis
Comparison 1 Drain versus 'no drain', Outcome 5 Same day discharge.
1.6
1.6. Analysis
Comparison 1 Drain versus 'no drain', Outcome 6 Hospital stay.
1.7
1.7. Analysis
Comparison 1 Drain versus 'no drain', Outcome 7 Operating time.

Update of

References

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