The Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair in Robotic Anti-Reflux Surgery: A Multi-Institutional Randomized Trial
Weill Medical College of Cornell University
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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
- DeviceBiosynthetic Mesh
The biosynthetic mesh group will undergo hiatal hernia repair with Phasix Mesh (Becton Dickinson, Franklin Lakes, NJ) reinforcement, secured with permanent suture.
- ProcedureHiatal Hernia Repair
The non-mesh group will undergo hiatal hernia repair with permanent suture only.
Locations (6)
- University of Southern California Keck School of MedicineLos Angeles, California
- Louisiana State University School of MedicineNew Orleans, Louisiana
- Washington University School of MedicineSt Louis, Missouri
- NYU Langone HealthNew York, New York
- Weill Cornell MedicineNew York, New York
- Lenox Hill HospitalNew York, New York