Clinical Trials Directory

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Active Not RecruitingNCT05357443

SH Dr. Chen Gastric Bypass Study

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Sanford Health · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

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

Detailed 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREGastric bypass with transection of vagal nervesVagal 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.
PROCEDUREGastric bypass without transection of vagal nervesDissection between the neurovascular bundle and the stomach, spareing the vagus nerves. This is the perigastric technique.

Timeline

Start date
2022-08-31
Primary completion
2026-09-01
Completion
2027-09-01
First posted
2022-05-02
Last updated
2025-09-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05357443. Inclusion in this directory is not an endorsement.