Truncal Vagotomy in Patients Undergoing Revisional Sleeve Gastrectomy to Gastric Bypass

Not Applicable

Not yet recruiting

• Conditions: GERD
• Interventions: Procedure: Truncal vagotomy

• 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

• Status Verified: 2021-05
• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-20
• Last Update Submitted: 2021-05-20
• Study First Posted: 2021-05-25
• Last Update Posted: 2021-05-25
• Study Start: 2021-07-01
• Primary Completion: 2026-08-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: NOT_YET_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

Arm && Interventions

Group	Intervention	Description
Truncal Vagotomy	Truncal vagotomy	Truncal vagotomy will be performed during other routine procedure.

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