Gastric Bypass
Conditions
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.
Interventions
PROCEDUREGastric 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.
PROCEDUREGastric bypass without transection of vagal nerves
Dissection between the neurovascular bundle and the stomach, spareing the vagus nerves. This is the perigastric technique.
Sponsors
National Institutes of Health (NIH)
Sanford Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed