SH Dr. Chen Gastric Bypass Study

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Gastric Bypass
• Intervention / Treatment: Procedure: Gastric bypass with transection of vagal nerves; Procedure: Gastric bypass without transection of vagal nerves

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brianne Wilkinson, MSN; Phone Number: 701-234-2028; Email: brianne.wilkinson@sanfordhealth.org

Study Locations

• United States
  • North Dakota
    • Fargo, North Dakota, United States, 58102
      • Sanford Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gastric Bypass with Transection of Vagal Nerves	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.
Placebo Comparator: Gastric Bypass Without Transection of Vagal Nerves	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sanford Health
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Sugong Chen, MD, Sanford Health

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2022
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SH Gastric Bypass Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No