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Procedure

Gastric Bypass with or without Vagal Nerve Transection for Gastric Bypass

N/A
Waitlist Available
Led By Sugong Chen, MD
Research Sponsored by Sanford Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years and older
Diagnosis of obesity or disorder of metabolism undergoing routine gastric bypass surgical intervention
Must not have
Under 18 years of age
Ineligible for gastric bypass surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from surgical intervention to five years after surgery

Summary

This trial looks at whether or not high levels of a stomach acid called gastrin lead to an increased risk of developing sores in the stomach lining.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from both surgical procedures can include nutritional deficiencies, digestive issues like nausea and vomiting, ulcers at the surgical site, and changes in bowel habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check ā€œYesā€ for the criteria below
Select...
I am 18 years old or older.
Select...
I am diagnosed with obesity or a metabolic disorder and am undergoing gastric bypass surgery.

Exclusion Criteria

You may be eligible for the trial if you check ā€œNoā€ for criteria below:
Select...
I am under 18 years old.
Select...
I cannot have gastric bypass surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from surgical intervention to five years after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and from surgical intervention to five years after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Marginal Ulcer

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Gastric Bypass with Transection of Vagal NervesActive Control1 Intervention
Group II: Gastric Bypass Without Transection of Vagal NervesPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Sanford HealthLead Sponsor
50 Previous Clinical Trials
66,901 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,823 Previous Clinical Trials
8,162,864 Total Patients Enrolled
Sugong Chen, MDPrincipal InvestigatorSanford Health

Media Library

Gastric bypass without transection of vagal nerves (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05357443 ā€” N/A
Gastric Bypass Research Study Groups: Gastric Bypass with Transection of Vagal Nerves, Gastric Bypass Without Transection of Vagal Nerves
Gastric Bypass Clinical Trial 2023: Gastric bypass without transection of vagal nerves Highlights & Side Effects. Trial Name: NCT05357443 ā€” N/A
Gastric bypass without transection of vagal nerves (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05357443 ā€” N/A
~3 spots leftby Feb 2025
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