SH Dr. Chen Gastric Bypass Study
Not Applicable
Active, not recruiting
- Conditions
- Gastric Bypass
- Interventions
- Procedure: Gastric bypass without transection of vagal nervesProcedure: Gastric bypass with transection of vagal nerves
- Registration Number
- NCT05357443
- Lead Sponsor
- Sanford Health
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gastric Bypass Without Transection of Vagal Nerves Gastric bypass without transection of vagal nerves - Gastric Bypass with Transection of Vagal Nerves Gastric bypass with transection of vagal nerves -
- Primary Outcome Measures
Name Time Method Incidence of Marginal Ulcer From surgical intervention to five years after surgery Number of participants with a change in serum gastrin levels compared pre- and post-surgery.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanford Health
🇺🇸Fargo, North Dakota, United States