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TSBL-Based Versus BMI-Based Biliopancreatic Limb Length in One-Anastomosis Gastric Bypass: Interim Results of a Randomized Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Kazakhstan
JSC National Scientific Center of Surgery named after A.N. Syzganov
RECRUITING
Almaty
Contact Information
Primary
Nurbol Orynbassar
nurbolorynbassar@gmail.com
+77474528797
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2027-11-01
Participants
Target number of participants: 100
Treatments
Experimental: TSBL-Based Group
Biliopancreatic limb length (BPL) individualized based on intraoperatively measured total small bowel length (TSBL), calculated as BPL = 0.35 × TSBL.
Active_comparator: BMI-Based Group
Biliopancreatic limb length (BPL) determined using standard fixed lengths based on BMI category: 150 cm for BMI 35-39.9, 180 cm for BMI 40-49.9, 200 cm for BMI ≥50.
Related Therapeutic Areas
Sponsors
Leads: National Scientific Center of Surgery named after A.N.Syzganov
Collaborators: Klaipėda University, Kazakh Medical University Higher School of Public Health

This content was sourced from clinicaltrials.gov