SH Dr. Chen Gastric Bypass Study

Sanford Health

Status: Active, not recruiting

Conditions: Gastric Bypass

Treatments: Procedure: Gastric bypass with transection of vagal nerves; Procedure: Gastric bypass without transection of vagal nerves

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05357443

SH Gastric Bypass Study

Details and patient eligibility

About

Evaluation of serum gastrin levels and their effect on marginal ulcer formation.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Gastric Bypass with Transection of Vagal Nerves

Active Comparator group

Treatment:

Procedure: Gastric bypass with transection of vagal nerves

Gastric Bypass Without Transection of Vagal Nerves

Placebo Comparator group

Treatment:

Procedure: Gastric bypass without transection of vagal nerves