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Biosynthetic Mesh for Hiatal Hernia

N/A

Recruiting

Led By Rasa Zarnegar, MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented diagnosis of gastroesophageal reflux disease

Be older than 18 years old

Must not have

Subject is undergoing emergent surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years postoperatively

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if using a specific type of mesh during anti-reflux surgery can lower the risk of hiatal hernias returning. People having this surgery will be split into two groups: one

Who is the study for?

This trial is for individuals who are undergoing antireflux surgery due to hiatal hernias. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information on who can participate.

What is being tested?

The study is testing if using biosynthetic mesh during hiatal hernia repair surgery can prevent the hernia from returning. Participants will be randomly placed in two groups: one receiving surgery with mesh and one without.

What are the potential side effects?

Potential side effects of using biosynthetic mesh in surgery may include infection, pain at the surgical site, inflammation, or an allergic reaction to the material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with acid reflux disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am scheduled for emergency surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Dysphagia Symptoms

Reflux Symptoms

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Biosynthetic MeshExperimental Treatment2 Interventions

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.

Group II: No MeshActive Control1 Intervention

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

0 / 2Eligibility criteria met