Trial sequential analyses of meta-analyses of complications in laparoscopic vs. small-incision cholecystectomy: more randomized patients are needed

Objective: Conclusions based on meta-analyses of randomized trials carry a status of "truth." Methodological components may identify trials with systematic errors ("bias"). Trial sequential analysis (TSA) evaluates random errors in meta-analysis. We analyzed meta-analyses on laparoscopic vs. small-incision cholecystectomy regarding different outcome measures for the occurrence of type I errors. Study Design and Setting: Using TSA, we calculated the required information size (IS) and the trial sequential monitoring boundaries regarding complications in our Cochrane review with meta-analyses of cholecystectomy. For each outcome, we calculated a low risk of bias heterogeneity-adjusted IS. As a sensitivity analysis, we calculated an a priori heterogeneity-adjusted IS. Results: According to the trial sequential analyses based on a low risk of bias heterogeneity-adjusted IS definitive evidence may he reached by conducting one more randomized trial. Information may be required on 582 and H 9 additional randomized patients to evaluate the effect on severe complications and serious adverse events (SAEs), respectively. Conclusion: Our results provide incentives to conduct a new trial with a low risk of bias focusing on a new composite outcome measure of SAEs to obtain conclusive evidence on which operative method to recommend. (C) 2010 Elsevier Inc. All rights reserved.