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RECRUITING Not applicable ClinicalTrials.gov

Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair

Sponsor: Weill Medical College of Cornell University • ClinicalTrials.gov ID: NCT06444347

Registry updated: 2026-08-19
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Description

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.

Interventions

  • Biosynthetic Mesh (Device)
    The biosynthetic mesh group will undergo hiatal hernia repair with Phasix Mesh (Becton Dickinson, Franklin Lakes, NJ) reinforcement, secured with permanent suture.
  • Hiatal Hernia Repair (Procedure)
    The non-mesh group will undergo hiatal hernia repair with permanent suture only.

Eligibility criteria

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

Conditions

Hiatal Hernia

Locations

  • University of Southern California Keck School of Medicine — Los Angeles, California, United States
  • Louisiana State University School of Medicine — New Orleans, Louisiana, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • NYU Langone Health — New York, New York, United States
  • Weill Cornell Medicine — New York, New York, United States
  • Lenox Hill Hospital — New York, New York, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record