The Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair in Robotic Anti-Reflux Surgery: A Multi-Institutional Randomized Trial
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• Documented diagnosis of gastroesophageal reflux disease
• Adults aged 18 years or older
• English speaking
• Subject is planned to undergo surgery for reflux disease
Locations
United States
California
University of Southern California Keck School of Medicine
NOT_YET_RECRUITING
Los Angeles
Louisiana
Louisiana State University School of Medicine
NOT_YET_RECRUITING
New Orleans
Missouri
Washington University School of Medicine
NOT_YET_RECRUITING
St Louis
New York
Lenox Hill Hospital
NOT_YET_RECRUITING
New York
NYU Langone Health
NOT_YET_RECRUITING
New York
Weill Cornell Medicine
RECRUITING
New York
Contact Information
Primary
Annabel Endean, NP
ant2028@med.cornell.edu
646-962-5250
Backup
Niloufar Salehi, MD
nis4017@med.cornell.edu
Time Frame
Start Date: 2024-06-10
Estimated Completion Date: 2030-07
Participants
Target number of participants: 200
Treatments
Experimental: Biosynthetic Mesh
The biosynthetic mesh group will undergo hiatal hernia repair with Phasix Mesh (Becton Dickinson, Franklin Lakes, NJ) reinforcement, secured with permanent suture. This is a biosynthetic mesh that completely reabsorbs in 12-18 months after surgery. The mesh is designed to provide strength during the initial healing phase after hernia repair, allowing for rapid tissue ingrowth and vascularization, gradually transferring the load to native tissue as it resorbs1. This mesh has been FDA approved for procedures involving soft tissue repair, such as hernia defects.
Active_comparator: No Mesh
The non-mesh group will undergo repair with permanent suture only.
Related Therapeutic Areas
Sponsors
Leads: Weill Medical College of Cornell University
Collaborators: Intuitive Surgical