Clinical trials

This prospective observational cohort study will develop and externally validate a human-supervised, explainable artificial-intelligence decision-support model for analysing factors associated with biliopancreatic limb length selection during one-anastomosis gastric bypass (OAGB). The study will record three prespecified factors: the percentage of the laparoscopic instrument segment J-I covered by visceral or omental fat (P\_JI = 100 × FI/JI), the measured total small-bowel length (TSBL), and the abdominal integral index (AII = (CD/AC) + (CG/EG) + (JI/FI)). The study will evaluate weight-loss effectiveness, nutritional and malabsorptive outcomes, bile/acid reflux, major complications, and technical feasibility. During model development, the AI system will not autonomously assign a BPL length. The operating bariatric surgeon will make the clinical decision, and the model will be evaluated for calibration, external validity, factor contribution, safety constraints, and abstention.

This study evaluates a new surgical device - the Metallic Anastomotic Clip (MAC) - for performing a laparoscopic bypass gastroenteroanastomosis with entero-enteric anastomosis (transit bipartition / "dual-path" procedure) in patients with type 2 diabetes mellitus (T2DM) who have overweight or Class I obesity (BMI 25-34.9 kg/m²). Currently, most bariatric and metabolic surgery procedures are only approved for patients with a BMI above 35 kg/m². However, many T2DM patients have BMI less 34.9 kg/m2 and cannot access surgical treatment under existing national guidelines. The transit bipartition procedure addresses this gap by creating a second food pathway from the stomach to the ileum while preserving normal duodenal digestion - producing a strong incretin (GLP-1) effect similar to GLP-1 receptor agonists (e.g., semaglutide), without causing excessive weight loss or requiring lifelong vitamin supplementation. The MAC is a novel compression anastomotic device designed to replace conventional hand-sewn or stapled anastomoses, potentially reducing complications such as anastomotic leak, bleeding, marginal ulcers, and strictures, while also lowering operative costs. Participants will be randomised into three groups. The study will assess metabolic outcomes (T2DM remission, glycaemic control), surgical safety, quality of life, and cost-effectiveness over a follow-up period of 2026-2027.