The future of bariatric surgery research: A worldwide mapping of registered trials.

Abstract

The bariatric surgery (BS) research landscape is a continuous evolving. Since the first described procedure, numerous different techniques have been developed by surgical teams. In this context, we conducted a systematic mapping of upcoming randomized controlled trials (RCTs) in BS for people with obesity. In June 2021, we performed a systematic review of RCTs evaluating BS versus another surgical procedure or versus a medical control group, through a search in ClinicalTrials.gov. There was no restriction on outcomes for study selection. A total of 62 RCTs were included, totaling 10,800 potential individuals to be included, with planned Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy surgeries the most common. The median number of patients planned to be enrolled is 78 (IQR: 50-143). Mean follow-up time is 12 months in 55% of trials and 4 years or more in 23%. The most frequent (81% of RCTs) outcomes to be investigated are obesity-related diseases with the study of type 2 diabetes, followed by weight loss, quality of life, and surgical complications. The rising number of BS procedures around the world has been followed by a subsequent surge in BS research. An increase in interest is observed in outcomes such as obesity-related diseases, intermediate metabolic markers, quality of life, and body composition.