NCT04901429RecruitingNot Applicable
Truncal Vagotomy in Patients Undergoing Revisional Sleeve Gastrectomy to Gastric Bypass
Baylor Research Institute2 sites in 1 country200 target enrollmentStarted: July 1, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Baylor Research Institute
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Esophageal pH monitoring
Study Overview
Brief Summary
The purpose of this study is to investigate the efficacy of performing a truncal vagotomy along with a sleeve to bypass revision surgery in reducing the severity and/or incidence of gastroesophageal reflux disease (GERD) post-surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participating subjects will need to be >18yrs of age and eligible for sleeve to bypass revision bariatric surgery.
- •Undergoing sleeve to bypass revision bariatric surgery.
Exclusion Criteria
- •Patients who are under the age of
- •Not eligible for sleeve to bypass revision bariatric surgery.
Outcomes
Primary Outcomes
Esophageal pH monitoring
Time Frame: approximately 6 months post operation
Esophageal pH monitoring
GERD-HRQL scores
Time Frame: approximately 6 months post operation
GERD-HRQL scores
Reflux symptom index questionnaire
Time Frame: approximately 6 months post operation
Reflux symptom index questionnaire
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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