Trials / Active Not Recruiting
Active Not RecruitingNCT05357443
SH Dr. Chen Gastric Bypass Study
Effect of Vagus Nerve Preservation During Gastric Bypass on Gastrin Level and Marginal Ulcer Formation
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Sanford Health · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2022-08-31
- Primary completion
- 2026-09-01
- Completion
- 2027-09-01
- First posted
- 2022-05-02
- Last updated
- 2025-09-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05357443. Inclusion in this directory is not an endorsement.