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NCT Number: NCT04901429

Truncal Vagotomy in Patients Undergoing Revisional Sleeve Gastrectomy to Gastric Bypass

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.

Recruiting

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Truncal vagotomy

Procedure

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

Primary outcomes

  1. GERD-HRQL scores

    Time frame: approximately 6 months post operation

    GERD-HRQL scores

  2. Esophageal pH monitoring

    Time frame: approximately 6 months post operation

    Esophageal pH monitoring

  3. Reflux symptom index questionnaire

    Time frame: approximately 6 months post operation

    Reflux symptom index questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Research Project Coordinator

CONTACT

[email protected]

214-820-4787

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
May 25, 2021
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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