Background. Meta-analyses of the implementation of a surgical safety checklist (SSC) in observational studies have shown a significant decrease in mortality and surgical complications.Objective. To determine the efficacy of the SSC using data from randomised controlled trials (RCTs).Methods. This meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and was registered with PROSPERO (CRD42015017546). A comprehensive search of six databases was conducted using the OvidSP search engine.Results. Four hundred and sixty-four citations revealed three eligible trials conducted in tertiary hospitals and a community hospital, with a total of 6 060 patients. All trials had allocation concealment bias and a lack of blinding of participants and personnel. A single trial that contributed 5 295 of the 6 060 patients to the meta-analysis had no detection, attrition or reporting biases. The SSC was associated with significantly decreased mortality (risk ratio (RR) 0.59, 95% confidence interval (CI) 0.42 - 0.85; p=0.0004; I2=0%) and surgical complications (RR 0.64, 95% CI 0.57 - 0.71; p