NCT04901429

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Jul 2021Aug 2028

First Submitted

Initial submission to the registry

May 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

6.1 years

First QC Date

May 20, 2021

Last Update Submit

May 21, 2025

Conditions

GERD

Outcome Measures

Primary Outcomes (3)

  • GERD-HRQL scores

    GERD-HRQL scores

    approximately 6 months post operation

  • Esophageal pH monitoring

    Esophageal pH monitoring

    approximately 6 months post operation

  • Reflux symptom index questionnaire

    Reflux symptom index questionnaire

    approximately 6 months post operation

Study Arms (2)

Truncal Vagotomy

EXPERIMENTAL

Truncal vagotomy will be performed during other routine procedure.

Procedure: Truncal vagotomy

No Truncal Vagotomy

NO INTERVENTION

No truncal vagotomy will be performed during other routine procedure.

Interventions

Truncal vagotomyPROCEDURE

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

Truncal Vagotomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who are under the age of 18.
  • Not eligible for sleeve to bypass revision bariatric surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Vagotomy, Truncal

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

VagotomyParasympathectomyAutonomic DenervationDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Research Project Coordinator

CONTACT

214-820-4787ADVANCEDSURGERYRESEARCH@bswhealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2021

First Posted

May 25, 2021

Study Start

July 1, 2021

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2028

Last Updated

May 25, 2025

Record last verified: 2025-05

Locations

US(1)