Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes (CLIMB II Study)
Salvador Navarrete
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.
Description
This study will be a prospective, randomized controlled trial with a 1:1 recruitment allocation ratio. Patients will be randomized to Standard fixed-length RYGB (sRYGB) or ratio-adjusted limb lengths (aRYGB) once the total small bowel length (TSBL) is fully counted intraoperatively. sRYGB will serve as the control group which will utilize BP and roux limb lengths of 100cm and 100cm, respectively. For the treatment group, aRYGB will incorporate a BP limb length measuring 30% and a roux limb of 15% of total small bowel length each. Outcomes to be investigated: Specific Aim 1: To determine sig…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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 sup…
Interventions
- ProcedureSurgery
Biliopancreatic limb and roux limb lengths measuring 30 and 15% respectively of patient's total small bowel length in RYGB
Location
- Cleveland clinicCleveland, Ohio