Types of Randomized Trials in Surgery

Summary: Randomized, controlled trials are acknowledged as the gold standard to establish treatment efficacy, and surgical therapies are increasingly being evaluated with this study design. Not all surgical therapies are amenable to investigation with randomized, controlled trials and in cases in which this design is appropriate, there are different trial designs to be considered. We present an overview of the use of randomized, controlled trials in surgery with a focus on trial design and on some of the challenges inherent to evaluating surgical therapies with randomized, controlled trials.