Truncal Vagotomy in Patients Undergoing Revisional Sleeve Gastrectomy to Gastric Bypass

Part of paid clinical trials in Dallas, Texas.

Sponsor
Baylor Research Institute
Study ID
NCT04901429
Status
Recruiting
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Conditions

  • GERD

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 1, 2021
Status verified
May 2025
Primary completion
Aug 1, 2027
Completion
Aug 1, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

GERD-HRQL scores [ Time Frame: approximately 6 months post operation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor University Medical CenterDallasTexas75246
Research Project Coordinator
[email protected]
214-820-4787
Research Manager
[email protected]
214-820-1722
Steven Leeds (PRINCIPAL_INVESTIGATOR)

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By research site
Baylor University Medical Center· Dallas, TX

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