Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair

Part of paid clinical trials in Los Angeles, California.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT06444347
Status
Recruiting
Apply to this trial

Conditions

  • Hiatal Hernia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.

Study 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. 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.

Key Dates

Start date
Jun 10, 2024
Status verified
Nov 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2030

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Anatomic hiatal hernia recurrence rate [ Time Frame: 1 year ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of Southern California Keck School of MedicineLos AngelesCalifornia90089-
Louisiana State University School of MedicineNew OrleansLouisiana70112-
Washington University School of MedicineSt LouisMissouri63110-
Lenox Hill HospitalNew YorkNew York10075
Mattia Ballo, MD
Filippo Filicori, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Luis Espinosa, MD
Tanuja Damani, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10065
Annabel Endean, NP
[email protected]
646-962-5250
Niloufar Salehi, MD
[email protected]
212-746-5187
Rasa Zarnegar, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
University of Southern California Keck School of Medicine· Los Angeles, CALouisiana State University School of Medicine· New Orleans, LAWashington University School of Medicine· St Louis, MOLenox Hill Hospital· New York, NYNYU Langone Health· New York, NYWeill Cornell Medicine· New York, NY

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