Clinical Research Directory

The Laparoscopic Transit Bipartition With Use Metalic Anastomosis Clip

Sponsor: The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Summary

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 fall below this threshold and cannot access surgical treatment under existing 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: MAC-assisted anastomosis, hand-sewn anastomosis, or stapled anastomosis. 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.

Official title: The Laparoscopic Transit Bipartition Without Gastrectomy With Use Metalic Anastomosis Clip (MAC) for Treating Type 2 Diabetes Mellitus and Obesity

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