Delivering successful randomized controlled trials in surgery: methods to optimize collaboration and study design

Randomized controlled trials in surgery are notoriously difficult to design and conduct, due to numerous methodological and cultural challenges. Over the last five years, several UK-based surgical trial-related initiatives have been funded to address these issues. These include the development of Surgical Trials Centers and Surgical Specialty Leads (individual surgeons responsible for championing RCTs in their specialist fields), both funded by the Royal College of Surgeons of England; networks of research-active surgeons in training; and investment in methodological research relating to surgical RCTs (to address issues such as recruitment, blinding, and the selection and standardization of interventions). This paper discusses these initiatives in more detail and provides exemplar cases to illustrate how the methodological challenges have been tackled. The initiatives have surpassed expectations, resulting in a renaissance in surgical research throughout the UK, such that the number of patients entering surgical RCTs has doubled.