Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes (CLIMB II Study)
Recruiting now · Not applicable
Conditions studied: Morbid Obesity
In brief
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.
Key facts
- Study ID
- NCT06293703
- Run by
- Salvador Navarrete
- People needed
- 262
- Starts
- 2024-01-12
- Expected to finish
- 2030-12-11
- Last updated by the study team
- 2026-03-20
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cleveland clinic — Cleveland, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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