Morbid Obesity, Obesity
Conditions
Keywords
One Anastomosis Gastric Bypass, Biliopancreatic Limb Length, Bariatric Surgery, Total Small Bowel Length, Weight Loss
Brief 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.
Detailed description
This is a single-center, prospective, randomized controlled trial comparing two methods for determining biliopancreatic limb length (BPLL) during laparoscopic one-anastomosis gastric bypass (OAGB) in patients with morbid obesity. Eligible patients aged 18-65 years with BMI ≥35 kg/m² (non-Asian) or ≥32.5 kg/m² (Asian populations) who were candidates for primary OAGB were randomized 1:1 using a computer-generated randomization sequence with sequentially numbered, opaque sealed envelopes. In the intervention (TSBL-based) group, total small bowel length (TSBL) was measured intraoperatively from the ligament of Treitz to the ileocecal valve, and BPLL was calculated as 0.35 × TSBL. In the control (BMI-based) group, BPLL was determined using standard fixed lengths based on BMI category (150 cm, 180 cm, or 200 cm). All other surgical steps were identical between groups. The primary outcome is percentage excess weight loss (%EWL) assessed longitudinally at baseline, 3, 6, and 12 months. Secondary outcomes include percentage total weight loss (%TWL), BMI, BMI loss, improvement of obesity-related comorbidities, and postoperative complications graded using the Clavien-Dindo classification. Statistical analysis uses linear mixed models to evaluate effects of group, time, and group-by-time interaction. Because blinding of patients and surgeons was not feasible given the nature of the surgical intervention, outcome assessment relied on objective anthropometric and clinical measures. This record reflects a planned interim analysis conducted on the first 75 of a planned total of 100 enrolled patients, with 51 patients having completed 12-month follow-up at the time of this analysis.
Interventions
PROCEDURETSBL-based biliopancreatic limb length determination
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.
PROCEDUREBMI-based biliopancreatic limb length determination
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.
Sponsors
National Scientific Center of Surgery named after A.N.Syzganov
Kazakh Medical University "Higher School of Public Health"
Klaipėda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Excess Weight Loss (%EWL) | Baseline, 3 months, 6 months, and 12 months post-surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Total Weight Loss (%TWL) | Baseline, 3 months, 6 months, and 12 months post-surgery | TWL assessed as percentage of total body weight loss relative to baseline weight. Assessed longitudinally over time using linear mixed models. |
| BMI Change | Baseline, 3 months, 6 months, and 12 months post-surgery | Change in body mass index (BMI, kg/m²) from baseline over time. |
| BMI Loss (BMIL) | Baseline, 3 months, 6 months, and 12 months post-surgery | Reduction in BMI from baseline, expressed as BMI loss (BMIL). |
| Improvement in Obesity-Related Comorbidities | 12 months post-surgery | Change in obesity-related comorbidities, including hypertension and ischemic heart disease, compared between groups. |
| Postoperative Complications | 12 months post-surgery | Postoperative complications documented and categorized according to the Clavien-Dindo classification system, including anaemia, hair loss, and bowel movement disorder. |
Countries
Kazakhstan
Contacts
CONTACTNurbol Orynbassar
Outcome results
None listed