SH Dr. Chen Gastric Bypass Study
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ClinicalTrials.gov Identifier: NCT05357443 |
Recruitment Status :
Active, not recruiting
First Posted : May 2, 2022
Last Update Posted : February 9, 2024
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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 |
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 |
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. |
- 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
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
United States, North Dakota | |
Sanford Health | |
Fargo, North Dakota, United States, 58102 |
Principal Investigator: | Sugong Chen, MD | Sanford Health |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |