Surgery Techniques for Obesity

(CLIMB II Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Salvador Navarrete, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Salvador Navarrete

Disqualifiers: Previous bariatric surgery, Active cancer, Pregnancy, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Roux-en-Y Gastric Bypass with Ratio-Adjusted Limb Lengths (aRYGB) for obesity?

Research shows that increasing the length of the Roux limb in Roux-en-Y gastric bypass (RYGB) can lead to greater weight loss in very obese patients, particularly those with a BMI over 50.

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Is Roux-en-Y Gastric Bypass generally safe for humans?

Roux-en-Y Gastric Bypass (RYGB) is a well-established surgical treatment for obesity and is considered the gold standard in bariatric surgery. While there is ongoing research about the optimal limb lengths for weight loss and minimizing nutritional issues, the procedure itself is generally regarded as safe for humans.

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How is the Roux-en-Y Gastric Bypass with Ratio-Adjusted Limb Lengths (aRYGB) treatment different from other obesity treatments?

The Roux-en-Y Gastric Bypass with Ratio-Adjusted Limb Lengths (aRYGB) is unique because it involves adjusting the lengths of the intestinal limbs during surgery to optimize weight loss and minimize nutritional deficiencies, which is not a standard approach in other obesity treatments.

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Eligibility Criteria

This trial is for individuals with obesity, specifically those who are candidates for Roux-en-Y Gastric Bypass (RYGB) surgery. Participants should be willing to undergo a surgical procedure where the lengths of certain parts of their small bowel will be adjusted based on their total small bowel length.

Inclusion Criteria

Patient who understands and accepts the need for a long-term follow-up

My BMI is between 40 and 60.

Patient who agrees to be included in the study

Exclusion Criteria

I am unable to make medical decisions for myself.

I have had surgery to remove part of my stomach or small intestine.

Individuals unable to understand and sign a written consent form

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Roux-en-Y Gastric Bypass surgery with either standard fixed-length or ratio-adjusted limb lengths

Surgery and immediate recovery

1 visit (in-person for surgery)

Postoperative Monitoring

Participants are monitored for weight loss, diabetes resolution, and metabolic syndrome alleviation

60 months

Visits at 6, 12, 24, and 60 months post-surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

Yearly after the first two years

Yearly visits

Participant Groups

The study is testing if adjusting the limb lengths in RYGB surgery to match individual patient's anatomy leads to better weight loss and health outcomes compared to using standard fixed limb lengths. Patients will be randomly assigned to receive either the adjusted or standard surgery.

Group I: aRYGB Experimental Treatment 1 Intervention

BP and roux limb lengths measuring 30% and 15% respectively of patient's total small bowel length.

Group II: sRYGB Active Control 1 Intervention

Standard fixed-length RYGB

Roux-en-Y Gastric Bypass with Ratio-Adjusted Limb Lengths (aRYGB) is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Roux-en-Y Gastric Bypass for:

• Morbid obesity
• Type 2 diabetes
• Hyperlipidemia
• Hypertension

🇺🇸 Approved in United States as Roux-en-Y Gastric Bypass for:

• Morbid obesity
• Type 2 diabetes
• Hyperlipidemia
• Hypertension

🇨🇦 Approved in Canada as Roux-en-Y Gastric Bypass for:

• Morbid obesity
• Type 2 diabetes
• Hyperlipidemia
• Hypertension

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cleveland clinic Cleveland, OH

Who Is Running the Clinical Trial?

Salvador Navarrete Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Long limb Roux en Y gastric bypass revisited. [2007] Roux-en-Y gastric bypass (RYGB) that is performed with at least a 150-cm Roux limb results in significantly greater weight loss than shorter (50 kg/m2). Conversely, longer Roux limb procedures do not provide greater weight loss in less obese (BMI

2. United States pubmed.ncbi.nlm.nih.gov

The role of total alimentary limb length in Roux-en-Y gastric bypass: a systematic review. [2022] Roux-en-Y gastric bypass (RYGB) is an established surgical treatment for obesity. Variations in limb length during RYGB procedures have been investigated for optimizing weight loss while minimizing nutritional deficiencies. The role of the total alimentary limb length (TALL; Roux limb plus common channel [CC]), however, is poorly defined.

3. Germany pubmed.ncbi.nlm.nih.gov

A short or a long Roux limb in gastric bypass surgery: does it matter? [2018] The Roux-en-Y gastric bypass (RYGB) still remains the gold standard in bariatric surgery. However, no consensus exists on the optimal limb lengths to induce maximum weight reduction. The aim of the present study was to assess the effect of a longer alimentary limb (AL) length on weight reduction after RYGB.

4. United States pubmed.ncbi.nlm.nih.gov

Does the RYGB common limb length influence hypertension remission and cardiometabolic risk factors? Data from the GATEWAY trial. [2020] Although Roux-en-Y gastric bypass (RYGB) results in significant weight loss and cardiometabolic risk factors improvements; there is no consensus whether limb lengths may influence these results.

5. Germany pubmed.ncbi.nlm.nih.gov

Effect of standard vs extended Roux limb length on weight loss outcomes after laparoscopic Roux-en-Y gastric bypass. [2018] Increasing the length of the Roux limb in open Roux-en-Y gastric bypass (RYGB) effectively increases excess weight loss in superobese patients with a body mass index (BMI) >50 kg/m2. Extending the RYGB limb length for obese patients with a BMI

6. United States pubmed.ncbi.nlm.nih.gov

Does the Length of the Common Channel as Part of the Total Alimentary Tract Matter? One Year Results from the Multicenter Dutch Common Channel Trial (DUCATI) Comparing Standard Versus Distal Roux-en-Y Gastric Bypass with Similar Biliopancreatic Bowel Limb Lengths. [2021] Although the laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is the gold-standard bariatric procedure, it remains uncertain what the optimal bowel limb lengths are to accomplish maximal weight loss while minimizing nutritional deficiencies and related gastro-intestinal complaints. The aim of this randomized controlled multicenter trial is to investigate the effect of significant lengthening of the length of the Roux limb (RL) at the cost of the length of the common channel (CC) while keeping the biliopancreatic limb (BPL) lengths the same on both study arms.