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History of Changes for Study: NCT05357443
SH Dr. Chen Gastric Bypass Study
Latest version (submitted February 7, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 27, 2022 None (earliest Version on record)
2 May 11, 2022 Study Status and Outcome Measures
3 July 20, 2022 Study Status
4 September 8, 2022 Recruitment Status, Study Status and Contacts/Locations
5 November 26, 2022 Study Status
6 January 2, 2024 Recruitment Status, Study Status, Contacts/Locations and Study Design
7 February 7, 2024 Study Status
Comparison Format:
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Study NCT05357443
Submitted Date:  April 27, 2022 (v1)
Open or close this module Study Identification
Unique Protocol ID: SH Gastric Bypass Study
Brief Title: SH Dr. Chen Gastric Bypass Study
Official Title: Effect of Vagus Nerve Preservation During Gastric Bypass on Gastrin Level and Marginal Ulcer Formation
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2022
Overall Status: Not yet recruiting
Study Start: May 2022
Primary Completion: November 2023 [Anticipated]
Study Completion: May 2027 [Anticipated]
First Submitted: April 19, 2022
First Submitted that
Met QC Criteria:		 April 27, 2022
First Posted: May 2, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:		 April 27, 2022
Last Update Posted: May 2, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Sanford Health
Responsible Party: Sponsor
Collaborators: National Institutes of Health (NIH)
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief 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.
Open or close this module Conditions
Conditions: Gastric Bypass
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 50 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of Marginal Ulcer
[ Time Frame: From surgical intervention to five years after surgery ]

Number of participants who develop marginal ulcer after gastric bypass utilizing transection of the vagal nerves technique versus without transection of the vagal nerves.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Brianne Wilkinson, MSN
Telephone: 701-234-2028
Email: brianne.wilkinson@sanfordhealth.org
Study Officials: Sugong Chen, MD
Principal Investigator
Sanford Health
Locations: United States, North Dakota
Sanford Health
Fargo, North Dakota, United States, 58102
Contact:Contact: Brianne Wilkinson, MSN brianne.wilkinson@sanfordhealth.org
Contact:Principal Investigator: Sugong Chen, MD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services