Jejuno-Ileal and Jejuno-Colic Diversion as a New Bariatric Method in the Treatment of Diabetes and Obesity: Study Protocol for a Prospective Randomised Clinical Trial

1.1 Background Obesity is a serious disease with a significant negative impact on global health. Bariatric metabolic surgery is an effective treatment option. Jejuno-ileal diversion (JID, side-to-side anastomosis between jejunum and ileum) and jejuno-colic diversion (JCD, side-to-side anastomosis between jejunum and transverse colon) are novel techniques in bariatric surgery. Evidence from other intestinal bypasses suggests positive effects on energy metabolism, bile acid circulation, satiety hormones, and insulin sensitivity. However, robust data on JID and JCD are limited, particularly regarding long-term outcomes, safety, and mechanisms of action. Comparative studies are scarce, creating an important gap in knowledge that must be addressed to define their role in bariatric practice. 1.2 Methods/Design This is a prospective randomised clinical trial. Study subjects who meet the Inclusion criteria and baseline procedures undergo surgery: first 40 patients JID / next 40 patients JCD. In addition, both arms (JID, JCD) will be divided into diabetic and non-diabetic groups and these groups will be compared within each respective arm. The subject will have follow-up clinic visits at Weeks 1, 2, and 3 and at Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 after the procedure. At each visit, the subject will undergo a review of medical history, evaluation of adverse events, physical examination, blood sampling. At specific intervals, mixed-meal tolerance test will be performed. Upper gastrointestinal (GI) series radiographic studies will be performed at baseline and 14 days after the procedure, focussing on the patency of the anastomosis. 1.3 Discussion This study will address the current evidence gap on intestine-preserving bariatric techniques. If effective, JID and JCD could offer a surgical option with sustained metabolic benefits, preserved intestinal continuity, and potentially fewer long-term complications compared to existing bariatric procedures. 1.4 Trial Registration ClinicalTrials.gov NCT06374368. Registered on 02/2021. 1.5 Status of trial Protocol trial version 1.0, dated 15.3.2019. Recruiting since 2019, expected to complete 2028.