Recruiting

Truncal Vagotomy

Sponsor:

Baylor Research Institute

Code:

NCT04901429

Conditions

GERD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Truncal vagotomy

Study Details

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.

Conditions

GERD

Study ID

NCT04901429

Start date

Jul 1, 2021

Status verified date

May, 2025

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Truncal Vagotomy

Truncal vagotomy will be performed during other routine procedure.

no intervention: No Truncal Vagotomy

No truncal vagotomy will be performed during other routine procedure.

Interventions

Truncal vagotomy

Truncal vagotomy will be performed in 50% of patients during other routine procedure.

Primary outcome measure

  • GERD-HRQL scores [ Time Frame: approximately 6 months post operation ]
  • Esophageal pH monitoring [ Time Frame: approximately 6 months post operation ]
  • Reflux symptom index questionnaire [ Time Frame: approximately 6 months post operation ]

Central Contacts and Locations

Central contacts

Research Project Coordinator

214-820-4787ADVANCEDSURGERYRESEARCH@bswhealth.org

Locations

Baylor University Medical Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

Research Project Coordinator

214-820-4787ADVANCEDSURGERYRESEARCH@bswhealth.org

Research Manager

214-820-1722ADVANCEDSURGERYRESEARCH@bswhealth.org

Principal Investigator:

Steven Leeds

More Information

Sponsor

Baylor Research Institute

Last update posted

May 25, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor Research Institute on 2025-05-25.