SH Dr. Chen Gastric Bypass Study

NCT ID: NCT05357443

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2027-09-30

Brief Summary

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

Detailed Description

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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

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Gastric Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gastric Bypass with Transection of Vagal Nerves

Group Type ACTIVE_COMPARATOR

Gastric bypass with transection of vagal nerves

Intervention Type PROCEDURE

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

Group Type PLACEBO_COMPARATOR

Gastric bypass without transection of vagal nerves

Intervention Type PROCEDURE

Dissection between the neurovascular bundle and the stomach, spareing the vagus nerves. This is the perigastric technique.

Interventions

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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.

Intervention Type PROCEDURE

Gastric bypass without transection of vagal nerves

Dissection between the neurovascular bundle and the stomach, spareing the vagus nerves. This is the perigastric technique.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Sanford Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sugong Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Sanford Health

Locations

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Sanford Health

Fargo, North Dakota, United States

Site Status

Countries

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United States

Other Identifiers

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SH Gastric Bypass Study

Identifier Type: -

Identifier Source: org_study_id

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