TSBL-Based Versus BMI-Based Biliopancreatic Limb Length in One-Anastomosis Gastric Bypass

Recruiting · NCT07796503 · Interventional (participants receive a specific treatment)

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Interventions studied

BMI-based biliopancreatic limb length determinationTSBL-based biliopancreatic limb length determination

What this trial is about

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.

Who can take part

Age range

18 Years to 65 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

1 location listed.

JSC "National Scientific Center of Surgery named after A.N. Syzganov" - Almaty, Kazakhstan

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →