Recruiting

Roux-en-Y Gastric Bypass

Sponsor:

Salvador Navarrete

Code:

NCT06293703

Conditions

Morbid Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Surgery

Study Details

Brief summary:

The investigators propose a randomized controlled trial comparing BP and roux limb lengths measuring 30 and 15% respectively of patient's total small bowel length versus current standard practice using fixed lengths. The findings would provide further insight into feasibility of standardizing RYGB limb lengths and optimizing resultant weight loss and metabolic effects. The investigators hypothesize RYGB with ratio-adjusted limb lengths (aRYGB) will result in higher total weight loss and resolution of metabolic syndrome comorbidities, including diabetes, hyperlipidemia, and hypertension compared to standard fixed-length RYGB (sRYGB). The study will also utilize the Short Form Rand 36-Item Health Survey (SF36) to determine differences in postoperative quality of life metrics.

Conditions

Morbid Obesity

Study ID

NCT06293703

Start date

Jan 12, 2024

Status verified date

Mar, 2026

Completion date

Dec 11, 2030

Anticipated

Primary completion date

Dec 11, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • morbidly obese patients (defined by BMI between 40 and 60).
  • Patient who understands and accepts the need for a long-term follow-up.
  • Patient who agrees to be included in the study

Exclusion Criteria:

  • individuals unable to understand and sign a written consent form
  • patients with history of previous bariatric surgery procedures
  • presence of a severe and evolutive life threatening pathology unrelated to obesity
  • previous gastric or small bowel resection
  • active cancer
  • pregnancy or desired to be pregnant during the study
  • mentally unbalanced patients under supervision or guardianship, patient unable to give consent

Study Design

Enrollment

262 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: aRYGB

BP and roux limb lengths measuring 30% and 15% respectively of patient's total small bowel length.

active comparator: sRYGB

Standard fixed-length RYGB

Interventions

Surgery

Biliopancreatic limb and roux limb lengths measuring 30 and 15% respectively of patient's total small bowel length in RYGB

Primary outcome measure

  • To determine change in TWL after aRYGB compared to sRYGB in morbidly obese patients [ Time Frame: 6,12,24 and 60 months from surgery ]

Central Contacts and Locations

Central contacts

Salvador Navarrete, MD

2162199211navarrs@ccf.org

Andrew Strong, MD

2162183869stronga3@ccf.org

Locations

Cleveland clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Salvador Navarrete, MD

216-219-9211navarrs@ccf.org

More Information

Sponsor

Salvador Navarrete

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Keywords

  • Bariatric surgery
  • Roux-n-Y gastric bypass
  • gastric bypass

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Salvador Navarrete on 2026-03-20.