Biosynthetic Mesh for Hiatal Hernia

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen by Rasa Zarnegar, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Dementia, Emergent surgery, Pregnancy, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Biosynthetic Mesh for Hiatal Hernia?

Research shows that using biosynthetic mesh in hiatal hernia repair can reduce the chance of the hernia coming back compared to traditional stitching methods. Studies also indicate that this type of mesh does not significantly increase swallowing difficulties after surgery.

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How is biosynthetic mesh treatment for hiatal hernia different from other treatments?

Biosynthetic mesh is unique because it is a resorbable (able to be absorbed by the body) material that aims to provide the benefits of both synthetic and biologic meshes, reducing complications like erosion and dysphagia (difficulty swallowing) while maintaining a lower recurrence rate of hernias compared to traditional suture repairs.

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Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

English speaking

I am scheduled for surgery to treat my reflux disease.

Exclusion Criteria

My doctor says I can't finish the study because of my dementia.

Pregnancy

I am scheduled for emergency surgery.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo anti-reflux surgery with or without biosynthetic mesh

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessment of dysphagia and reflux symptoms

5 years

Participant Groups

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.

Group I: Biosynthetic Mesh Experimental Treatment 2 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 Mesh Active Control 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

NYU Langone Health New York, NY

Lenox Hill Hospital New York, NY

University of Southern California Keck School of Medicine Los Angeles, CA

Washington University School of Medicine Saint Louis, MO

More Trial Locations

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University Lead Sponsor

Intuitive Surgical Industry Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Paraesophageal hernia repair with biomesh does not increase postoperative dysphagia. [2022] Laparoscopic techniques have led to hiatal procedures being performed with less morbidity but higher failure rates. Biologic mesh (biomesh) has been proposed as an alternative to plastic mesh to achieve durable repairs while minimizing stricturing and erosion. This paper documents the lack of significant dysphagia after the placement of biomesh during hiatal hernia repair.

2. United States pubmed.ncbi.nlm.nih.gov

Short-term results for laparoscopic repair of large paraesophageal hiatal hernias with Gore Bio A® mesh. [2022] The application of mesh-reinforced hiatal closure has resulted in a significant reduction in recurrence rates in comparison with primary suture repair. One of the most debated issues is the risk of complications related to the use of the prosthesis, such as esophageal erosion and postoperative dysphagia. The aim of this study is to present our short-terms results in the treatment of laparoscopic paraesophageal hiatal hernia (LPHH) with a synthetic polyglycolic acid:trimethylene carbonate mesh (Gore Bio A(®)).

3. France pubmed.ncbi.nlm.nih.gov

The use of biosynthetic mesh in giant hiatal hernia repair: is there a rationale? A 3-year single-center experience. [2021] Reinforced prosthetic crural repair is particularly indicated for giant hiatal hernias. The rationale is to reduce the recurrence rate in the long term. The aim of our study is to evaluate the outcomes of laparoscopic giant hiatal hernia repair using a biosynthetic mesh.

4. France pubmed.ncbi.nlm.nih.gov

Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair. [2022] Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix™) over 24 months.

5. Germany pubmed.ncbi.nlm.nih.gov

Hiatal hernia repair with biosynthetic mesh reinforcement: a qualitative systematic review. [2023] Reinforcement of crural closure with synthetic resorbable mesh has been proposed to decrease recurrence rates after hiatal hernia repair, but continues to be controversial. This systematic review aims to evaluate the safety, efficacy, and intermediate-term results of using biosynthetic mesh to augment the hiatus.

6. United States pubmed.ncbi.nlm.nih.gov

When the Mesh Goes Away: An Analysis of Poly-4-Hydroxybutyrate Mesh for Complex Hernia Repair. [2022] Mesh reinforcement is a cornerstone of modern ventral hernia repair (VHR); yet, complications with synthetic mesh and cost of biologic have created a need for alternative options. Biosynthetic mesh is a resorbable scaffold that theoretically leverages the benefits and minimizes deficiencies of existing mesh types. This study evaluates 2-year outcomes following poly-4-hydroxybutyrate (P4HB) mesh reinforcement for complex VHR.