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
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