Health TrialsbyHealthPanel

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

ConditionMorbid Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSalvador Navarrete

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Surgery

    Procedure/Surgery

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

Treatment groups

262 Participants
are divided into 2 treatment groups
Group A: aRYGBExperimental treatment 1 intervention
Group B: sRYGBActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

To determine change in TWL after aRYGB compared to sRYGB in morbidly obese patients

Measured in kilograms

Time frame
6,12,24 and 60 months from surgery

Secondary outcomes

1

To compare rates of DM resolution between aRYGB Vs sRYGB by DM subgroup analysis

Measured by subjects achieving HbA1c less than or equal to 6.5% and subjects able to wean and/or discontinue glycemic control medications

Time frame
6,12,24 and 60 months from surgery
2

To investigate postoperative efficacy rates of aRYGB compared to sRYGB on alleviating metabolic syndrome in morbid obesity

Measured by a change in serum lipid levels and subjects requiring less antihypertensives

Time frame
6,12,24 and 60 months from surgery
3

To investigate the presence of postoperative vitamin and nutritional deficiencies between the groups.

Time frame
6,12,24 and 60 months from surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Salvador Navarrete

Lead sponsor

The Cleveland Clinic

Sponsor institution

Source ClinicalTrials.gov
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