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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Salvador Navarrete
Study ID
NCT06293703
Status
Recruiting
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Conditions

  • Morbid Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Surgery — PROCEDURE
    Biliopancreatic limb and roux limb lengths measuring 30 and 15% respectively of patient's total small bowel length in RYGB

Study Details

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.

Key Dates

Start date
Jan 12, 2024
Status verified
Mar 2026
Primary completion
Dec 11, 2030
Completion
Dec 11, 2030

Study Design

Enrollment
262 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

To determine change in TWL after aRYGB compared to sRYGB in morbidly obese patients [ Time Frame: 6,12,24 and 60 months from surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland clinicClevelandOhio44195
Salvador Navarrete, MD
[email protected]
216-219-9211

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By research site
Cleveland clinic· Cleveland, OH

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