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NCT06444347NARecruitingAccepts Healthy Volunteers

Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair

Weill Medical College of Cornell University

Start Date

6/10/2024

Completion Date

7/1/2030

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

Age Range: 18 years to No maximum

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 Criteria: * Physician deems the subject is unable to complete the study due to documented dementia. * Subject is undergoing emergent surgery. * Pregnancy * Patient has known allergy to tetracycline hydrochloride or kanamycin sulfate

Interventions

DEVICE

Biosynthetic Mesh

PROCEDURE

Hiatal Hernia Repair

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Conditions

Hiatal Hernia

Locations

University of Southern California Keck School of Medicine

Los Angeles, California 90089

United States

Louisiana State University School of Medicine

New Orleans, Louisiana 70112

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

NYU Langone Health

New York, New York 10016

United States

Weill Cornell Medicine

New York, New York 10065

United States

Lenox Hill Hospital

New York, New York 10075

United States