Comparing Robot-Assisted and Laparoscopic Bariatric Surgery for Adults with Obesity A Randomized Multicenter Study on Health and Costs

What this Trial Is About

Obesity is a serious condition affecting 17% of the French population, with bariatric and metabolic surgery recognized as the primary treatment. This trial evaluates whether using the Da Vinci robot for bariatric surgery offers a cost-effective advantage over conventional laparoscopic surgery by potentially reducing complications and improving quality of life. The study is a randomized, controlled, single-blind, multicenter trial involving 482 patients undergoing primary or revisional bariatric surgery. Participants are randomly assigned to receive either robot-assisted bariatric surgery using the Da Vinci X or Xi system or conventional laparoscopic surgery. The study collects data on healthcare consumption linked to the surgeries by matching patient information with the French National Health Insurance database. Quality of life is assessed with the EQ-5D-5L questionnaire. Both surgical approaches follow the recommendations of the French National Authority for Health regarding eligibility based on body mass index and comorbidities. During the study, participants will undergo assessments of surgical complications, pain levels, readmission and reintervention rates, quality of life through questionnaires, duration of surgery, hospital stay, weight loss, and treatment changes up to 12 months after surgery. Data on costs and health outcomes will be analyzed to calculate the incremental cost-effectiveness ratio at one year. The total study duration extends to July 2028, with ongoing monitoring of health and economic outcomes relevant to bariatric surgery.

Health-economic Assessment of Robot-assisted Bariatric Surgery