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?

This trial examines two types of weight-loss surgeries, including Roux-en-Y Gastric Bypass with Ratio-Adjusted Limb Lengths (aRYGB), to determine which is more effective for weight loss and improving conditions like diabetes and high blood pressure. It investigates whether altering the length of certain parts of the small intestine during surgery provides more benefits than the standard method. The trial seeks participants who are morbidly obese, with a body mass index (BMI) between 40 and 60, and who are willing to attend long-term follow-ups. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to better weight-loss solutions.

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 prior data suggests that these surgery techniques are safe for obesity treatment?

Research has shown that Roux-en-Y Gastric Bypass (RYGB) is generally safe. Adjusting the lengths of certain intestinal sections during surgery has yielded promising results. Studies have found that these adjustments do not significantly impact short-term issues like nutrition and recovery within the first 30 days, indicating that the surgery is usually well-tolerated in the short term. Reviews by the American Society for Metabolic and Bariatric Surgery confirm the procedure's safety, noting that altering the lengths does not increase risks. Overall, these findings suggest that most patients can handle the surgery well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for the Roux-en-Y Gastric Bypass with Ratio-Adjusted Limb Lengths (aRYGB) technique because it personalizes the surgery based on the patient's anatomy. Unlike the standard fixed-length Roux-en-Y Gastric Bypass (sRYGB), aRYGB adjusts the lengths of the biliopancreatic (BP) and roux limbs to 30% and 15% of the patient's total small bowel length, respectively. This tailored approach aims to optimize the surgery's effectiveness for weight loss and metabolic improvement by better aligning with individual patient needs. By customizing the limb lengths, researchers hope to enhance outcomes and reduce complications associated with the traditional surgery.

What evidence suggests that these surgery techniques could be effective for obesity?

Research has shown that Roux-en-Y gastric bypass (RYGB) effectively treats severe obesity. This trial will compare two surgical techniques: the standard fixed-length RYGB (sRYGB) and the adjusted RYGB (aRYGB), which aligns the bypass with the patient's small intestine length. Studies suggest that aRYGB might lead to better weight loss and help manage conditions like diabetes and high blood pressure. This personalized approach aims to improve outcomes by tailoring the surgery to each individual. The American Society for Metabolic and Bariatric Surgery states that RYGB is effective, though some individuals might require additional surgery to enhance results. While researchers continue to study the effectiveness of the adjusted method, early signs indicate it could improve the success of the traditional RYGB. ^{1 3 4 5 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 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 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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06293703

Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass ... The investigators propose a randomized controlled trial comparing BP and roux limb lengths measuring 30 and 15% respectively of patient's total small bowel ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12346900/

Counting Limb Length Ratios in Roux-en-Y Gastric Bypass We hypothesize that a ratio-adjusted small bowel to Roux and BP limb lengths in RYGB results in superior outcomes. Objectives: This study aims ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1550728923004446

American Society for Metabolic and Bariatric Surgery ... Roux-en-Y gastric bypass (RYGB) effectively treats severe obesity, but some patients may require revisional surgery like limb lengthening (LL) for ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11906517/

Ring Augmentation of the Roux-en-Y Gastric Bypass The ring-augmented Roux-en-Y gastric bypass (raRYGB) has been reported to result in higher long-term weight loss compared to regular Roux-en-Y ...

5. nature.com nature.com/articles/s41366-022-01186-0

Length of biliopancreatic limb in Roux-en-Y gastric bypass ... No difference in outcomes following short versus long BLP in RYGB was identified at 12–72 months post-operatively, namely in BMI reduction, ...

6. soard.org soard.org/article/S1550-7289(24)00306-X/fulltext

A037 Effect of Limb Length Ratio on Roux-en-Y Gastric ... Roux and biliopancreatic limb lengths were not altered due to this study. Patient outcomes, including TWL, nutritional status, and 30-day complications were ...