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NCT05357443 Clinical Trial

SH Dr. Chen Gastric Bypass Study

Gastric Bypass Clinical Trial

Official title:
Effect of Vagus Nerve Preservation During Gastric Bypass on Gastrin Level and Marginal Ulcer Formation

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05357443
Other study ID # SH Gastric Bypass Study
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 31, 2022
Est. completion date February 28, 2026

Study information
Verified date February 2024
Source Sanford Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

Prospective, randomized, interventional trial. Participants will be randomized to one of two surgical techniques, either with transection of the vagal nerves, or without. Outcomes including compare marginal ulcer rates will be compared using serum gastrin levels before and after surgery and gastric pH during surgery.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 50
Est. completion date February 28, 2026
Est. primary completion date February 28, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 years and older - Diagnosis of obesity or disorder of metabolism undergoing routine gastric bypass surgical intervention - Capable of giving signed informed consent. Exclusion Criteria: - Under 18 years of age - Ineligible for gastric bypass surgery - Pregnant women or women actively seeking to become pregnant.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Gastric bypass with transection of vagal nerves
Vagal nerve interruption above the level of the stomach is a known treatment for complicated peptic ulcer disease. It is not commonly performed during routine gastric bypass. The vagi are, however, interrupted part-way down the stomach to create the gastric pouch. This is the pars flaccida technique.
• Gastric bypass without transection of vagal nerves
Dissection between the neurovascular bundle and the stomach, spareing the vagus nerves. This is the perigastric technique.

Locations
Country Name City State
United States Sanford Health Fargo North Dakota

Sponsors (2)
Lead Sponsor Collaborator
Sanford Health National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Marginal Ulcer Number of participants with a change in serum gastrin levels compared pre- and post-surgery. From surgical intervention to five years after surgery
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