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The Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair in Robotic Anti-Reflux Surgery: A Multi-Institutional Randomized Trial

Clinical Trial Details

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. The mesh used is approved by the U.S. Food and Drug Administration (FDA). 

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. 

Any required post-surgical visits will be standard-of-care visits that participants would have regardless of study participation.  

Key Eligibility: 

Inclusion Criteria:
 1. Documented diagnosis of gastroesophageal reflux disease
 2. Adults aged 18 years or older
 3. Participant is planned to undergo surgery for reflux disease
   
 Exclusion
 1. Known allergy to tetracycline hydrochloride or kanamycin sulfate
 2. Pregnant
   

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Niloufar Salehi
nis4017@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2311026766

ClinicalTrials.gov:

NCT06444347

Status

Open to Enrollment

Age Group

Adult

Sponsor