Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair

Last updated: December 2, 2024
Sponsor: Weill Medical College of Cornell University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heartburn

Hernia

Treatment

Biosynthetic Mesh

Hiatal Hernia Repair

Clinical Study ID

NCT06444347
23-11026766
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The aim of this study is to find out if using a certain kind of mesh can reduce the chances of hiatal hernias coming back after anti-reflux surgery. Participants undergoing antireflux surgery will be assigned to one of two groups, a group that has surgery with mesh, or a group that has surgery without mesh.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented diagnosis of gastroesophageal reflux disease

  • Adults aged 18 years or older

  • English speaking

  • Subject is planned to undergo surgery for reflux disease

Exclusion

Exclusion Criteria:

  • Physician deems the subject is unable to complete the study due to documenteddementia.

  • Subject is undergoing emergent surgery.

  • Pregnancy

  • Patient has known allergy to tetracycline hydrochloride or kanamycin sulfate

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Biosynthetic Mesh
Phase:
Study Start date:
June 10, 2024
Estimated Completion Date:
July 31, 2030

Connect with a study center

  • University of Southern California Keck School of Medicine

    Los Angeles, California 90033
    United States

    Site Not Available

  • Louisiana State University School of Medicine

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts 01805
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Lenox Hill Hospital

    New York, New York 10075
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • New York University Grossman School of Medicine

    New York, New York 10016
    United States

    Site Not Available

  • Weill Cornell Medicine

    New York, New York 10065
    United States

    Active - Recruiting

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