Comparing different limb lengths in gastric bypass surgery for weight loss
Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes (CLIMB II Study)
This study is testing if adjusting the lengths of parts of gastric bypass surgery can help morbidly obese patients lose more weight and improve health issues like diabetes and high blood pressure compared to standard surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 262 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06293703 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of limb length ratios in Roux-en-Y gastric bypass surgery on weight loss and metabolic outcomes in morbidly obese patients. Participants will be randomly assigned to receive either standard fixed-length gastric bypass or a ratio-adjusted version that customizes limb lengths based on the patient's total small bowel length. The study aims to determine if the ratio-adjusted approach leads to greater total weight loss and improved resolution of metabolic syndrome comorbidities, such as diabetes and hypertension. Quality of life metrics will also be assessed postoperatively using the SF36 survey.
Who should consider this trial
Good fit: Ideal candidates for this study are morbidly obese individuals with a BMI between 40 and 60 who are willing to commit to long-term follow-up.
Not a fit: Patients with a history of previous bariatric surgery, severe unrelated health conditions, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective gastric bypass procedures that enhance weight loss and improve metabolic health in morbidly obese patients.
How similar studies have performed: While there have been studies on gastric bypass techniques, this specific approach of using ratio-adjusted limb lengths is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cleveland, Ohio
- Cleveland clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Salvador Navarrete, MD — The Cleveland Clinic
- Study coordinator: Salvador Navarrete, MD
- Email: navarrs@ccf.org
- Phone: 2162199211
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.