The Transit Bipartition With the Use of a Metallic Anastomosis Clip and Circular Fundocorporeal Gastroplication

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 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.

Eligibility

Inclusion Criteria:

* Clinical diagnosis of Type 2 Diabetes Mellitus
* BMI 25-35 kg/m2

Exclusion Criteria:

* Insulin dependent diabetes
* BMI \<25 and \>35 kg/m2
* History of surgery on the stomach
* Less than 18 or more than 65 years of age
* Psychiatric illness
* Patients unwilling or unable to provide informed consent

Conditions5

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