Clinical Trials

Recognizing that often knowledge gaps are identified and high-quality evidence does not exist to guide practice, we plan to complete the “evidence cycle” through the establishment of a collaborative group to conduct pragmatic, practice-changing trials in surgery.

Plan

Our plan is to establish a Steering Committee including representation from each U of T affiliated hospitals to perform trials where knowledge gaps have been identified through the Best Practice in Surgery. We will leverage existing mechanisms for data collection where possible, including the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP). As a guiding principle, trials will be pragmatic, simple, and non-regulated (i.e. not new drugs/devices) to maximize applicability and feasibility.

Rationale

Randomized Controlled Trials (RCTs) are the most rigorous and informative research design to evaluate the effectiveness of a medical intervention. RCTs are resource-intense compared to other research designs, but are far more likely to yield reliable, accurate information that can be incorporated into clinical care. There is a dearth of strong evidence to guide surgeons in the conduct of even fundamental practices, such as location of incisions for surgery, selection of appropriate antibiotics to prevent infection, and technique of wound closure. These core elements of surgical decision-making occur thousands of times daily across Canada, but are predominantly guided by anecdotal experience and surgeon preference.