Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair

Weill Cornell Medicine (WCM)

Status

Enrolling

Conditions

Hiatal Hernia

Treatments

Device: Biosynthetic Mesh

Procedure: Hiatal Hernia Repair

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06444347

23-11026766

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Biosynthetic Mesh

Experimental group

Description:

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.

Treatment:

Procedure: Hiatal Hernia Repair

Device: Biosynthetic Mesh

No Mesh

Active Comparator group

Description:

The non-mesh group will undergo repair with permanent suture only.

Treatment:

Procedure: Hiatal Hernia Repair