Skip to main content
Clinical Trials/NCT04901429
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
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

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials

Truncal Vagotomy in Patients Undergoing... | Clinical Trial