Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes (CLIMB II Study)
Recruiting · NCT06293703 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed across 1 US state.
- Cleveland clinic - Cleveland, Ohio, United States