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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNational Scientific Center of Surgery named after A.N.Syzganov

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

BMI below the defined thresholds

Severe decompensated cardiac, pulmonary, hepatic, or renal disease

Acute inflammatory conditions

Active gastric or duodenal ulcer

Trial design

Design model

Parallel

Treatments tested in this trial

  • TSBL-based biliopancreatic limb length determination

    Procedure/Surgery

    Biliopancreatic limb length individualized intraoperatively based on measured total small bowel length (TSBL), calculated as BPL = 0.35 × TSBL, prior to laparoscopic one-anastomosis gastric bypass.

  • BMI-based biliopancreatic limb length determination

    Procedure/Surgery

    Biliopancreatic limb length determined using standard fixed lengths based on preoperative BMI category (150 cm, 180 cm, or 200 cm), prior to laparoscopic one-anastomosis gastric bypass.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: TSBL-Based GroupExperimental treatment 1 intervention
Group B: BMI-Based GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Excess Weight Loss (%EWL)

EWL defined as the proportion of weight loss relative to excess baseline weight, with ideal body weight defined as BMI 25 kg/m². Assessed longitudinally over time using linear mixed models.

Time frame
Baseline, 3 months, 6 months, and 12 months post-surgery

Secondary outcomes

1

Percentage of Total Weight Loss (%TWL)

TWL assessed as percentage of total body weight loss relative to baseline weight. Assessed longitudinally over time using linear mixed models.

Time frame
Baseline, 3 months, 6 months, and 12 months post-surgery
2

BMI Change

Change in body mass index (BMI, kg/m²) from baseline over time.

Time frame
Baseline, 3 months, 6 months, and 12 months post-surgery
3

BMI Loss (BMIL)

Reduction in BMI from baseline, expressed as BMI loss (BMIL).

Time frame
Baseline, 3 months, 6 months, and 12 months post-surgery
4

Improvement in Obesity-Related Comorbidities

Change in obesity-related comorbidities, including hypertension and ischemic heart disease, compared between groups.

Time frame
12 months post-surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Scientific Center of Surgery named after A.N.Syzganov

Lead sponsor

Kazakh Medical University "Higher School of Public Health"

Collaborator

Klaipėda University

Collaborator