RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-12
Study Completion:2030-12-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06293703

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * morbidly obese patients (defined by BMI between 40 and 60).
  2. * Patient who understands and accepts the need for a long-term follow-up.
  3. * Patient who agrees to be included in the study
  1. * individuals unable to understand and sign a written consent form
  2. * patients with history of previous bariatric surgery procedures
  3. * presence of a severe and evolutive life threatening pathology unrelated to obesity
  4. * previous gastric or small bowel resection
  5. * active cancer
  6. * pregnancy or desired to be pregnant during the study
  7. * mentally unbalanced patients under supervision or guardianship, patient unable to give consent

Contacts and Locations

Study Contact

Salvador Navarrete, MD
CONTACT
2162199211
navarrs@ccf.org
Andrew Strong, MD
CONTACT
2162183869
stronga3@ccf.org

Principal Investigator

Salvador Navarrete, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Cleveland clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Salvador Navarrete

  • Salvador Navarrete, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-12
Study Completion Date2030-12-11

Study Record Updates

Study Start Date2024-01-12
Study Completion Date2030-12-11

Terms related to this study

Keywords Provided by Researchers

  • Bariatric surgery
  • Roux-n-Y gastric bypass
  • gastric bypass

Additional Relevant MeSH Terms

  • Morbid Obesity