Abstract
OBJECTIVES: To assess the effects of device-based circumcisions compared with standard surgical techniques in adolescent and adult males (10 years old and above). METHODS: We performed a comprehensive search with no restrictions to the language of publication or publication status. We included randomised controlled trials (RCTs) of device-based circumcisions compared to standard surgical dissection-based circumcision conducted by health professionals in a medical setting. We reported study results as risk ratios (RRs) or mean differences (MDs) using 95% confidence intervals (CIs) and a random-effects model. We used the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to evaluate the overall certainty of the evidence for each outcome. RESULTS: A total of 18 trials met the inclusion criteria. These trials did not report severe adverse events (AEs; 11 trials, 3472 participants). There may be a slight increase in moderate AEs for devices compared to surgical techniques (RR 1.31, 95% CI 0.55-3.10; I(2) = 68%; 10 trials, 3370 participants; low-certainty evidence); this corresponds to eight more (ranging from 15 fewer to 84 more) moderate AEs per 1000 participants. We are uncertain about the difference in mild AEs between groups when devices are used compared to surgical techniques (RR 1.09, 95% CI 0.44-2.72; I(2) = 91%; 10 trials, 3370 participants; very low-certainty evidence). CONCLUSIONS: We found no serious AEs using a circumcision device compared to surgical techniques. Still, they may slightly increase moderate AEs, and it is unclear whether there is a difference in mild AEs. High-quality trials evaluating this intervention are needed to provide further certainty regarding the rates of AEs. Clinicians, patients, and policymakers can use these results combined with their contextual factors to inform the best approach that suits their healthcare settings.