Adaptation of the By-Band randomized clinical trial to By-Band-Sleeve to include a new intervention and maintain relevance of the study to practice.
C A RogersB C ReevesJ ByrneJ L DonovanG MazzaS ParamasivanR C AndrewsS WordsworthJ ThompsonJane M BlazebyR Welbournnull nullPublished in: The British journal of surgery (2017)
Adaptation of a two-group surgical RCT can allow evaluation of a third procedure and maintain relevance of the RCT to practice. It also optimizes the use of existing trial infrastructure to answer an additional important research question. Registration number: ISRCTN00786323 (http://www.isrctn.com/).