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Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes (CLIMB II Study)

RecruitingNAAges 18 Years - 70 YearsAllSalvador Navarrete
NCT06293703 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Surgery
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Where

1 site
Cleveland clinic
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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