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SH Dr. Chen Gastric Bypass Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05357443
Recruitment Status : Active, not recruiting
First Posted : May 2, 2022
Last Update Posted : February 9, 2024
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Sanford Health

Study Description
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Brief Summary:
Evaluation of serum gastrin levels and their effect on marginal ulcer formation.

Condition or disease Intervention/treatment Phase
Gastric Bypass Procedure: Gastric bypass with transection of vagal nerves Procedure: Gastric bypass without transection of vagal nerves Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Vagus Nerve Preservation During Gastric Bypass on Gastrin Level and Marginal Ulcer Formation
Actual Study Start Date : August 31, 2022
Estimated Primary Completion Date : February 28, 2025
Estimated Study Completion Date : February 28, 2026
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Marginal Ulcer [ Time Frame: From surgical intervention to five years after surgery ]
    Number of participants with a change in serum gastrin levels compared pre- and post-surgery.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05357443


Locations
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United States, North Dakota
Sanford Health
Fargo, North Dakota, United States, 58102
Sponsors and Collaborators
Sanford Health
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Sugong Chen, MD Sanford Health
More Information
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Responsible Party: Sanford Health
ClinicalTrials.gov Identifier: NCT05357443    
Other Study ID Numbers: SH Gastric Bypass Study
First Posted: May 2, 2022    Key Record Dates
Last Update Posted: February 9, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No