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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Evaluation of serum gastrin levels and their effect on marginal ulcer formation.

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.

What data supports the effectiveness of the treatment Gastric bypass with or without vagal nerve transection?

Research suggests that gastric bypass surgery is effective for weight loss in obesity, and the addition of vagal nerve transection may enhance this effect. Studies in animals and humans indicate that bypassing the stomach can lead to significant weight loss, and modifying the vagal nerve may further influence outcomes. ^{1 2 3 4 5}

Is gastric bypass surgery with or without vagal nerve transection safe for humans?

Research indicates that gastric bypass surgery generally maintains normal stomach function and is not likely to cause ulcers, suggesting it is safe. However, studies in animals show changes in nerve patterns after surgery, which may need further investigation for human safety. ^{1 2 3 5 6}

How does gastric bypass with or without vagal nerve transection differ from other treatments for obesity?

This treatment is unique because it involves either preserving or cutting the vagal nerves during gastric bypass surgery, which may influence weight loss and postoperative complications. Cutting the vagal nerves could potentially enhance weight loss by altering gut-brain communication, while preserving them might reduce complications. ^{1 5 7 8 9}

Research Team

Sugong Chen, MD

Principal Investigator

Sanford Health

Eligibility Criteria

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 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

References

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

Combination of bypassing stomach and vagus dissection in high-fat diet-induced obese rats-a long-term investigation. [2021]

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

Vagal sparing surgical technique but not stoma size affects body weight loss in rodent model of gastric bypass. [2022]

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

Vagal innervation of the bypassed stomach following gastric bypass. [2018]

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

Vagal nerve dissection during pouch formation in laparoscopic Roux-Y-gastric bypass for technical simplification: does it matter? [2021]

5. England pubmed.ncbi.nlm.nih.gov

Vagal innervation patterns following Roux-en-Y gastric bypass in the mouse. [2021]

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

Deep brain stimulation compared with bariatric surgery for the treatment of morbid obesity: a decision analysis study. [2010]

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

Transection versus preservation of the neurovascular bundle of the lesser omentum in primary Roux-en-Y gastric bypass surgery. [2016]

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

Early results of simplified proximal high selective transgastric vagotomy without drainage. [2009]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The Phantom Satiation Hypothesis of Bariatric Surgery. [2023]