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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Cleveland clinic
RECRUITING
Cleveland
Contact Information
Primary
Salvador Navarrete, MD
navarrs@ccf.org
2162199211
Backup
Andrew Strong, MD
stronga3@ccf.org
2162183869
Time Frame
Start Date: 2024-01-12
Estimated Completion Date: 2030-12-11
Participants
Target number of participants: 262
Treatments
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
Sponsors
Leads: Salvador Navarrete

This content was sourced from clinicaltrials.gov