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Randomized controlled trials in surgery are notoriously difficult to design and conduct due to numerous methodological and cultural challenges. Over the last 5 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 randomized controlled trials 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 randomized controlled trials (to address issues such as recruitment, blinding, and the selection and standardization of interventions). This article discusses these initiatives more in 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 United Kingdom, such that the number of patients entering surgical randomized controlled trials has doubled.

Original publication




Journal article


Clinical trials (London, England)

Publication Date





211 - 218


1 Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.


Humans, Feasibility Studies, Pilot Projects, Cooperative Behavior, Evidence-Based Medicine, Research Design, Patient Selection, Randomized Controlled Trials as Topic, General Surgery, United Kingdom