Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair
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
200 participants
Jun 10, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- Documented diagnosis of gastroesophageal reflux disease
- Adults aged 18 years or older
- English speaking
- Subject is planned to undergo surgery for reflux disease
Exclusion Criteria4
- 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
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Interventions
The biosynthetic mesh group will undergo hiatal hernia repair with Phasix Mesh (Becton Dickinson, Franklin Lakes, NJ) reinforcement, secured with permanent suture.
The non-mesh group will undergo hiatal hernia repair with permanent suture only.
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT06444347