Recruiting

Mesh Surgery

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06444347

Conditions

Hiatal Hernia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Biosynthetic Mesh

Hiatal Hernia Repair

Study Details

Brief 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.

Conditions

Hiatal Hernia

Study ID

NCT06444347

Start date

Jun 10, 2024

Status verified date

Aug, 2026

Completion date

Jul, 2030

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Biosynthetic Mesh

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

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Annabel Endean, NP

646-962-5250ant2028@med.cornell.edu

Niloufar Salehi, MD

nis4017@med.cornell.edu

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Annabel Endean, NP

646-962-5250ant2028@med.cornell.edu

Niloufar Salehi, MD

212-746-5187nis4017@med.cornell.edu

Principal Investigator:

Rasa Zarnegar, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-08-19.