TSBL-Based Versus BMI-Based Biliopancreatic Limb Length in One-Anastomosis Gastric Bypass
NCT07796503
Summary
This study compares two surgical techniques used during one-anastomosis gastric bypass (OAGB) surgery for patients with severe obesity. During this operation, surgeons create a bypass of part of the small intestine, and the length of this bypassed segment (called the biliopancreatic limb) affects both weight loss and the risk of nutritional side effects. In this trial, one group of patients has the limb length calculated individually based on the measured total length of their small intestine (TSBL-based method), while the other group receives a limb length based on standard body mass index (BMI) categories (BMI-based method). The study compares weight loss outcomes, improvement of obesity-related health problems, and complication rates between the two approaches over 12 months after surgery. The trial is being conducted at a single center in Almaty, Kazakhstan, and plans to enroll 100 patients total; this record reflects an interim analysis based on the first 75 patients enrolled.
Eligibility
Inclusion Criteria: * Age between 18 and 65 years * BMI ≥35 kg/m² in non-Asian populations or ≥32.5 kg/m² in Asian populations * Presence or absence of metabolic comorbidities (including type 2 diabetes, hypertension, and dyslipidaemia) * Eligibility for primary one-anastomosis gastric bypass (OAGB) * Provision of written informed consent Exclusion Criteria: * BMI below the defined thresholds * Severe decompensated cardiac, pulmonary, hepatic, or renal disease * Acute inflammatory conditions * Active gastric or duodenal ulcer * Psychiatric disorders or substance abuse * Pregnancy or breastfeeding * Active malignancy * Severe intra-abdominal adhesions due to prior surgery * Secondary obesity related to hypothalamic-pituitary-adrenal axis disorders
Conditions3
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NCT07796503