200 Participants Needed

Truncal Vagotomy for Acid Reflux

KM
CS
RP
Overseen ByResearch Project Coordinator
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Baylor Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether truncal vagotomy, a surgical procedure, can reduce acid reflux (heartburn) after certain weight loss surgeries. Some participants will undergo this procedure during their surgery, while others will not. The trial aims to determine if the procedure affects the management of gastroesophageal reflux disease (GERD) symptoms. Individuals undergoing a sleeve to bypass revision surgery who regularly experience acid reflux might be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance GERD management following weight loss surgery.

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

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 truncal vagotomy is safe for reducing GERD post-surgery?

Research has shown that truncal vagotomy, a surgery involving the cutting of the vagus nerve to reduce stomach acid, has long been used to treat peptic ulcer disease (PUD). This surgery was once the primary treatment for PUD. Historical data indicates that truncal vagotomy was widely used and generally safe.

However, some studies report a risk of accidental nerve damage during the surgery, occurring in 10% to 42% of cases. These injuries usually did not significantly affect acid reflux outcomes, but they are important to consider. Overall, despite the risks, the procedure's common use in the past suggests it is relatively safe.12345

Why are researchers excited about this trial?

Truncal vagotomy is unique because it targets acid reflux by cutting the vagus nerve, which reduces stomach acid production. This is different from standard treatments like proton pump inhibitors or H2 blockers, which primarily work by blocking acid production through medication. Researchers are excited about truncal vagotomy because it offers a surgical solution that might provide long-term relief for patients who haven't responded well to typical medications. Additionally, this approach could potentially reduce the need for lifelong medication use, offering a different pathway to manage acid reflux effectively.

What evidence suggests that truncal vagotomy might be an effective treatment for GERD?

Research has shown that truncal vagotomy, a surgery that cuts parts of a nerve in the stomach, can help lower stomach acid. This reduction in acid can alleviate symptoms of gastroesophageal reflux disease (GERD). Truncal vagotomy has been studied for its effectiveness in treating ulcers and reducing acid levels. Evidence suggests it might also help manage acid reflux. Studies have found that it can decrease the recurrence of acid-related issues. This trial will compare truncal vagotomy, performed during other routine procedures, with no truncal vagotomy to evaluate its effectiveness in easing GERD symptoms, especially when other surgeries have not succeeded.12678

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are eligible for a specific weight loss surgery, changing from sleeve gastrectomy to gastric bypass. It's not open to those who don't meet the surgical criteria.

Inclusion Criteria

I am having surgery to change my sleeve gastrectomy to a gastric bypass.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Participants undergo truncal vagotomy along with sleeve to bypass revision surgery

1 day
1 visit (in-person)

Follow-up

Participants are monitored for GERD severity and incidence post-surgery

6 months
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Truncal vagotomy
Trial Overview The study is testing if adding a procedure called truncal vagotomy during the revision from sleeve gastrectomy to gastric bypass can reduce acid reflux symptoms after surgery.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Truncal VagotomyExperimental Treatment1 Intervention
Group II: No Truncal VagotomyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials
210
Recruited
205,000+

Citations

Truncal Vagotomy - StatPearls - NCBI BookshelfProspective controlled vagotomy trial for duodenal ulcer: primary results, sequelae, acid secretion, and recurrence rates two to five years after operation.
Truncal Vagotomy for Acid RefluxThe purpose of this study is to investigate the efficacy of performing a truncal vagotomy along with a sleeve to bypass revision surgery in reducing the ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/7250749/
Effective of highly selective vagotomy upon the lower ...Recently highly selective vagotomy has been suggested as both a cause of gastro-oesophageal reflux and a potential cure. This study was designed to ...
Management of failure after surgery for gastro-esophageal ...The efficacy of fundoplication declines over time, and approximately 30% of patients will have re-appearance of GERD within seven to ten years [55], [56].
Acid-reducing vagotomy is associated with reduced risk of...Studies showed that HP infections were diagnosed in 90% to 100% of uncomplicated duodenal ulcer patients and in 60% to 100% of uncomplicated gastric ulcer ...
Long-term results after reoperation for failed antireflux ...Primary surgical treatment for gastroesophageal reflux disease (GERD) is associated with a long-term success rate of 80% to 90%,1, 2, 3 whereas reoperations are ...
LONG-TERM RESULTS AFTER REOPERATION FOR ...Long-term functional results (Table II) were classified as excellent in 65 patients (41.6%), good in 29 (18.6%), fair in 43 (27.6%), and poor in 19 (12.2%). or ...
Effect of Vagus Nerve Injury on the Outcome of Antireflux ...Results: The prevalence of unintended, accidental VNI ranged from 10 to 42% after ARS. No clear differences were seen in outcome for reflux ...
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