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Recruiting NCT04901429

Truncal Vagotomy in Patients Undergoing Revisional Sleeve Gastrectomy to Gastric Bypass

No phase Interventional GERD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Truncal vagotomy.
Who it may be relevant to
Registry conditions: GERD. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Baylor University Medical Center — Dallas

Identifiers

NCT: NCT04901429 · 021-171

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗