Gastric Bypass with or without Vagal Nerve Transection for Gastric Bypass

Overseen By Brianne Wilkinson, MSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sanford Health

Disqualifiers: Under 18, Pregnancy, Ineligible surgery

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different types of gastric bypass surgery might influence the risk of developing ulcers post-surgery. It compares two groups: one undergoing gastric bypass with a cut to the vagal nerve (which helps control stomach functions) and the other without this cut. Researchers aim to determine if cutting this nerve alters levels of a hormone called gastrin and affects ulcer formation. Suitable participants are those with obesity who are already planning to undergo gastric bypass surgery. As an unphased trial, participation provides an opportunity to contribute to understanding the surgical impacts on ulcer risk.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that gastric bypass surgery is generally safe, regardless of whether the vagal nerves are cut. Studies have found that this surgery maintains normal stomach function and is unlikely to cause ulcers, supporting its safety.

However, differences exist between the two methods. Cutting the vagal nerves can lead to more complications after surgery, potentially causing more issues during recovery. In contrast, preserving the vagal nerves might reduce certain side effects, such as dumping syndrome, where food moves too quickly through the stomach.

Overall, both methods are considered safe, but each presents different risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore how cutting the vagal nerve during gastric bypass surgery might change outcomes for patients. Unlike standard gastric bypass, which leaves the vagal nerve intact, one of the study treatments involves transecting this nerve. The vagal nerve plays a role in hunger and digestion, so researchers are investigating if its transection can enhance weight loss or metabolic improvements. This exploration could lead to more effective surgical options for obesity and related conditions.

What evidence suggests that this trial's treatments could be effective for marginal ulcer formation?

This trial will compare gastric bypass with transection of the vagal nerves to gastric bypass without it. Research has shown that cutting the vagus nerve during gastric bypass surgery is generally safe and does not affect key outcomes like weight loss. Studies indicate that patients experience similar weight loss regardless of whether the nerve is cut. However, those with the nerve cut tend to reach their maximum weight loss slightly sooner. Some evidence suggests that cutting the nerve might lead to slightly more weight loss, but the difference is not significant. Vagal nerve therapy has been proven to safely assist with mild-to-moderate weight loss. Overall, the procedure is effective, with both methods offering benefits for managing weight. ^{4 5 6 7 8}

Who Is on the Research Team?

Sugong Chen, MD

Principal Investigator

Sanford Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with obesity or metabolic disorders who are already planning to have gastric bypass surgery. They must be able to give informed consent. It's not for those under 18, women who are or want to become pregnant soon, or anyone ineligible for the surgery.

Inclusion Criteria

I am able to understand and sign the consent form.

I am diagnosed with obesity or a metabolic disorder and am undergoing gastric bypass surgery.

Exclusion Criteria

Pregnant women or women actively seeking to become pregnant.

I am under 18 years old.

I cannot have gastric bypass surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Intervention

Participants undergo gastric bypass surgery with or without transection of the vagal nerves

1 day

Post-Surgery Monitoring

Participants' serum gastrin levels and gastric pH are monitored post-surgery

4 weeks

Follow-up

Participants are monitored for safety and effectiveness, including incidence of marginal ulcers

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Gastric bypass without transection of vagal nerves
• Gastric bypass with transection of vagal nerves

Trial Overview The study compares two types of gastric bypass surgeries: one where vagal nerves are cut and one where they're left intact. The goal is to see how these methods affect gastrin levels in the blood and if they influence ulcer formation after surgery.

How Is the Trial Designed?

Group I: Gastric Bypass with Transection of Vagal Nerves Active Control 1 Intervention

Group II: Gastric Bypass Without Transection of Vagal Nerves Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Sanford Health

Lead Sponsor

Trials

53

Recruited

2,067,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4333325/

Sleeve Gastrectomy and Roux-en-Y Gastric Bypass Alter the ... Our results indicate that VSG significantly increased the density of vagal afferents in the NTS and the DMV (61.89% ± 2.03% and 2.13% ± 0.21%, resp.) when ...

2. liebertpub.com liebertpub.com/doi/10.1089/bari.2020.0052

The Effect of Vagus Nerve Preservation on Gastrointestinal ... Most authors concluded that transection of the vagus nerve is well tolerated, efficient, and does not impact clinical, functional, and laboratory outcomes. In ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40779279/

Vagal-Sparing Versus Non-Vagal-Sparing Roux-en-Y ... While overall weight outcomes were similar, VS reached maximum percentage of total weight loss (%TWL) earlier (p = 0.02). Both groups showed ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155072891500307X

Transection versus preservation of the neurovascular ... Some surgeons choose to transect the neurovascular bundle (NBT), containing branches of the vagus nerve, because this might be related to additional weight loss ...

5. karger.com karger.com/esr/article/64/4/365/860810/Vagal-Nerve-Therapy-in-the-Management-of-Obesity-A

Vagal Nerve Therapy in the Management of Obesity Conclusions: Vagal nerve therapy can safely result in a mild-to-moderate improvement in weight loss. However, further clinical trials are ...

6. withpower.com withpower.com/trial/phase-bypass-gastric-4-2022-b0f08

Gastric Bypass with or without Vagal Nerve Transection for ... Research indicates that gastric bypass surgery generally maintains normal stomach function and is not likely to cause ulcers, suggesting it is safe.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK553157/

Roux-en-Y Gastric Bypass - StatPearls - NCBI Bookshelf Long-term data results consistently demonstrate the safety, efficacy, and durability of MBS in the treatment of clinically severe obesity and its ...

8. researchgate.net researchgate.net/publication/394408991_Vagal-Sparing_Versus_Non-Vagal-Sparing_Roux-en-Y_Gastric_Bypass_Complications_and_Weight_Outcomes

Vagal-Sparing Versus Non-Vagal-Sparing Roux-en-Y ... 002). Conclusions: Transection of the neurovascular bundle in RYGB is associated with more complications. Furthermore, weight loss is not ...