The Laparoscopic Transit Bipartition With Use Metalic Anastomosis Clip

Overview

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.

Background: Type 2 diabetes mellitus (T2DM) is a major global health burden characterised by progressive micro- and macrovascular complications despite pharmacological management. Bariatric and metabolic surgery (BMS) has demonstrated superiority over conservative therapy in achieving durable T2DM remission, primarily through incretin-mediated and weight-independent mechanisms. However, standard BMS indications (BMI ≥35 kg/m²) exclude the majority of T2DM patients who present with overweight or Class I obesity (BMI 25-34.9 kg/m²). Transit bipartition (the "dual-path" procedure) offers a promising alternative: it preserves the natural duodenal alimentary route while creating an additional gastro-ileal bypass with an entero-enteric anastomosis, thereby stimulating GLP-1 secretion and restoring the incretin effect without the malabsorptive consequences of gastric bypass. This eliminates the need for lifelong micronutrient supplementation. Device: The Metallic Anastomotic Clip (MAC) is an authors' proprietary compression anastomotic device developed for laparoscopic creation of bypass gastroenteroanastomosis and entero-enteric anastomosis. The device applies controlled radial compression to achieve tissue approximation and anastomotic healing without sutures or staples. A preliminary pilot study in 10 patients demonstrated technical feasibility and safety. Study Design: Prospective, randomised controlled trial (RCT) with three parallel arms: Group 1 (MAC): laparoscopic transit bipartition with bypass gastroenteroanastomosis and entero-enteric anastomosis using the Metallic Anastomotic Clip Group 2 (Hand-sewn): laparoscopic transit bipartition using manual suture anastomosis Group 3 (Stapled): laparoscopic transit bipartition using mechanical stapled anastomosis Primary Outcomes: HbA1c, fasting glucose, HOMA-IR, remission rate of T2DM (per 2021 ADA/EASD/IFSO consensus criteria) at 12 and 24 months; anastomotic complication rate (leak, bleeding, stricture, marginal ulcer). Secondary Outcomes: BMI, quality of life, operative time, length of hospital stay, morbidity and mortality. Setting: Tsoi G.V. Surgical Research and Education Centre, Astana Medical University; Surgical Centre of Professor Oral Ospanov, Astana, Kazakhstan. Regulatory: The study will be conducted in accordance with GCP guidelines and the Declaration of Helsinki. The MAC device will be protected by a utility model patent prior to trial initiation.