Truncal Vagotomy in Patients Undergoing Revisional Sleeve Gastrectomy to Gastric Bypass

NCT ID: NCT04901429

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2028-08-01

Brief Summary

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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

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Conditions

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GERD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Truncal Vagotomy

Truncal vagotomy will be performed during other routine procedure.

Group Type EXPERIMENTAL

Truncal vagotomy

Intervention Type PROCEDURE

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

No Truncal Vagotomy

No truncal vagotomy will be performed during other routine procedure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Truncal vagotomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Baylor University Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Research Project Coordinator

Role: CONTACT

214-820-4787

Facility Contacts

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Research Project Coordinator

Role: primary

214-820-4787

Research Manager

Role: backup

214-820-1722

Other Identifiers

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021-171

Identifier Type: -

Identifier Source: org_study_id

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