Surgery Techniques for Obesity

(CLIMB II Trial)

Overseen By Salvador Navarrete, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Salvador Navarrete

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: Surgery and immediate recovery

262 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 2 3 4 6}

Who Is on the Research Team?

Salvador Navarrete, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Roux-en-Y Gastric Bypass with Ratio-Adjusted Limb Lengths (aRYGB)

Trial Overview 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Salvador Navarrete

Lead Sponsor

Trials

1

Recruited

260+

Published Research Related to This Trial

In superobese patients (BMI >50 kg/m2), Roux-en-Y gastric bypass (RYGB) with a 150-cm Roux limb leads to significantly greater weight loss compared to procedures with shorter Roux limbs (<100 cm).

For patients with a BMI <50 kg/m2, longer Roux limb procedures do not enhance weight loss, and extending the Roux limb from 150 cm to 200 cm does not increase the risk of nutritional complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long limb Roux en Y gastric bypass revisited. Brolin, RE.[2007]

A systematic review of 21 studies on Roux-en-Y gastric bypass (RYGB) found that a total alimentary limb length (TALL) of 400 cm or less, combined with a common channel length of less than 200 cm, significantly increases the risk of protein malnutrition in patients, with 3.4% to 63.6% requiring limb lengthening due to this deficiency.

There is some evidence suggesting that shorter TALL may impact weight loss outcomes, as 4 out of 6 studies indicated a relationship between TALL length and weight loss, highlighting the need for further research to clarify these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of total alimentary limb length in Roux-en-Y gastric bypass: a systematic review. Wang, A., Poliakin, L., Sundaresan, N., et al.[2022]

In a study of 730 patients who underwent Roux-en-Y gastric bypass (RYGB), increasing the alimentary limb length from 100 cm to 150 cm did not result in significant differences in weight loss outcomes over a mean follow-up of 37 months.

The overall complication rates were low, with a 30-day mortality rate of 0.13% and no significant differences in short- or long-term complications between patients with short and long alimentary limbs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A short or a long Roux limb in gastric bypass surgery: does it matter? Dogan, K., Homan, J., Aarts, EO., et al.[2018]

In a study involving 100 patients undergoing Roux-en-Y gastric bypass (RYGB), 55.6% experienced remission of hypertension after one year, indicating the procedure's effectiveness in improving this condition.

The length of the common limb (CLL) in RYGB did not significantly affect hypertension remission or changes in cardiometabolic risk factors, suggesting that other factors may play a more critical role in these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the RYGB common limb length influence hypertension remission and cardiometabolic risk factors? Data from the GATEWAY trial. Schiavon, CA., Santos, RN., Santucci, EV., et al.[2020]

In a study of 58 patients with a BMI < 50 kg/m2 undergoing laparoscopic Roux-en-Y gastric bypass, extending the Roux limb length from 100 cm to 150 cm did not significantly improve weight loss outcomes over a 1-year follow-up period.

Both groups experienced weight loss that plateaued after 6 months, with a trend suggesting a higher proportion of patients achieving over 50% excess weight loss in the extended limb group, but this was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of standard vs extended Roux limb length on weight loss outcomes after laparoscopic Roux-en-Y gastric bypass. Feng, JJ., Gagner, M., Pomp, A., et al.[2018]

In a study involving 444 patients, the Very Long Roux Limb LRYGB (VLRL-LRYGB) procedure did not result in significantly different weight loss compared to the Standard LRYGB (S-LRYGB) after one year, indicating that increasing the Roux limb length may not enhance weight loss outcomes.

The rates of malabsorption requiring surgical adjustments were low and similar between the two groups (1.4% for VLRL-LRYGB and 0.9% for S-LRYGB), suggesting that both procedures are relatively safe in terms of nutritional deficiencies, but long-term effects still need to be evaluated.

NCBI (Pubmed)

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. Gadiot, RPM., Leeman, M., Biter, LU., et al.[2021]

Citations

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

Long limb Roux en Y gastric bypass revisited. [2007]

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]

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

A short or a long Roux limb in gastric bypass surgery: does it matter? [2018]

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]

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]

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]