ClinicalTrials.gg
RecruitingNCT07796503TSBL-OAGBUpdated Sep 1, 2026

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

An interventional study of TSBL-based biliopancreatic limb length determination and BMI-based biliopancreatic limb length determination in Morbid Obesity and Obesity, sponsored by National Scientific Center of Surgery named after A.N.Syzganov. Recruiting at 1 site in Kazakhstan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by National Scientific Center of Surgery named after A.N.Syzganov · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Oct 2023, registered Aug 2026).
  • Started Oct 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Morbid Obesity
  • Obesity

Keywords

  • One Anastomosis Gastric Bypass
  • Biliopancreatic Limb Length
  • Bariatric Surgery
  • Total Small Bowel Length
  • Weight Loss
03

In context

Obesity, Morbid

941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.

This study's planned enrollment of 100 is above the median of 62 across 602 interventional studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

This is the only study on the registry with National Scientific Center of Surgery named after A.N.Syzganov as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 18 and 65 years
  • ≥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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Severe intra-abdominal adhesions due to prior surgery
  • Secondary obesity related to hypothalamic-pituitary-adrenal axis disorders
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    TSBL-Based Group

    Biliopancreatic limb length (BPL) individualized based on intraoperatively measured total small bowel length (TSBL), calculated as BPL = 0.35 × TSBL.

    Procedure: TSBL-based biliopancreatic limb length determination

  • 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.

    Procedure: BMI-based biliopancreatic limb length determination

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.

06

What researchers measure

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

  5. Postoperative Complications

    Postoperative complications documented and categorized according to the Clavien-Dindo classification system, including anaemia, hair loss, and bowel movement disorder.

    Time frame: 12 months post-surgery

07

Study locations

1 of 1 sites recruiting
  • JSC "National Scientific Center of Surgery named after A.N. Syzganov"
    Almaty, Kazakhstan
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Individual participant data underlying the results reported in this article, after deidentification, may be shared with researchers upon reasonable request.

Supporting information: Study protocol

Time frame: Data will be available beginning 3 months after article publication, with no defined end date, for researchers who provide a methodologically sound proposal.

Access criteria: Data will be available to researchers who provide a methodologically sound proposal, upon reasonable request to the corresponding author (Nurbol Orynbassar, nurbolorynbassar@gmail.com).

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07796503
Lead sponsor
National Scientific Center of Surgery named after A.N.Syzganov
Collaborators
Kazakh Medical University "Higher School of Public Health", Klaipėda University
Responsible party
Sponsor
First posted
Sep 1, 2026
Start date
Oct 1, 2023
Primary completion
Nov 1, 2027 (estimated)
Completion
Nov 1, 2027 (estimated)
Last update
Sep 1, 2026

Study contacts

Nurbol Orynbassar
Contact
nurbolorynbassar@gmail.com
+77474528797

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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