Truncal Vagotomy in Patients Undergoing Revisional Sleeve Gastrectomy to Gastric Bypass

Not Applicable

Recruiting

• Conditions: GERD

• Registration Number: NCT04901429
• Lead Sponsor: Baylor Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-25
• Study Start: 2021-07-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-25
• Primary Completion: 2027-08-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 18.
• Not eligible for sleeve to bypass revision bariatric surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Esophageal pH monitoring	approximately 6 months post operation	Esophageal pH monitoring
GERD-HRQL scores	approximately 6 months post operation	GERD-HRQL scores
Reflux symptom index questionnaire	approximately 6 months post operation	Reflux symptom index questionnaire

Trial Locations

Locations (1)

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States