A guide to planning and executing a surgical randomized controlled trial.

Evidence-based medicine requires that treatments given to patients demonstrate effectiveness. The randomized controlled trial (RCT) has become the preeminent study design to assess the efficacy of treatments. Randomized controlled trials are frequently used to evaluate pharmaceutical treatments but are less often used in surgery. The lack of surgical RCTs is partly due to ethical and methodological concerns associated with surgical interventions. We provide a guide to planning and conducting a surgical RCT.