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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study will also utilize the Short Form Rand 36-Item Health Survey (SF36) to determine differences in postoperative quality of life metrics."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility 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

Study sites (1)

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