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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

Research Team

Rasa Zarnegar, MD

Principal Investigator

Weill Medical College of Cornell University

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

Treatment Details

Interventions

• Biosynthetic Mesh (Other)

Trial Overview 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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Dr. Robert Min

Weill Medical College of Cornell University

Chief Executive Officer since 2024

MD, MBA

Dr. Adam R. Stracher

Weill Medical College of Cornell University

Chief Medical Officer since 2024

MD

Intuitive Surgical

Industry Sponsor

Trials

80

Recruited

49,600+

Gary Guthart

Intuitive Surgical

Chief Executive Officer since 2010

PhD in Engineering, California Institute of Technology

Henry Charlton

Intuitive Surgical

Chief Medical Officer since 2023

MD from an unspecified institution

Findings from Research

In a study of 89 patients undergoing hiatal hernia repair, the use of biomesh did not significantly increase the rates of dysphagia (difficulty swallowing) compared to traditional non-mesh repairs, suggesting it is a safe option for this procedure.

While initial follow-up showed more dysphagia and bloating in patients with biomesh, by the second follow-up, non-mesh patients reported more overall symptoms, indicating that biomesh may provide better long-term outcomes in symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paraesophageal hernia repair with biomesh does not increase postoperative dysphagia. Goers, TA., Cassera, MA., Dunst, CM., et al.[2022]

In a study of 10 patients with large paraesophageal hiatal hernias, the use of Gore Bio A(®) mesh during laparoscopic repair resulted in a low recurrence rate of only 10% after a median follow-up of 20.3 months.

No mesh-related complications were reported, indicating that the use of this synthetic mesh is safe for patients undergoing this type of surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term results for laparoscopic repair of large paraesophageal hiatal hernias with Gore Bio A® mesh. Priego Jiménez, P., Salvador Sanchís, JL., Angel, V., et al.[2022]

In a study of 44 patients with giant hiatal hernias, laparoscopic repair using a biosynthetic mesh resulted in a low recurrence rate of only 4.5% after 36 months, indicating effective long-term outcomes.

There were no mesh-related complications reported over the 3-year follow-up period, suggesting that the biosynthetic mesh is a safe option for reinforcing hiatal repairs.

NCBI (Pubmed)

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. Tartaglia, E., Cuccurullo, D., Guerriero, L., et al.[2021]

The systematic review included 18 studies with 1846 patients and found that using biosynthetic mesh for hiatal hernia repair is safe, with no reported mesh erosions and only one case of stenosis requiring reoperation.

Patients experienced significant improvements in symptoms and quality of life after surgery, although recurrence rates varied widely from 0.9% to 25%, highlighting the need for more standardized definitions and further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hiatal hernia repair with biosynthetic mesh reinforcement: a qualitative systematic review. Lima, DL., de Figueiredo, SMP., Pereira, X., et al.[2023]

References

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

Paraesophageal hernia repair with biomesh does not increase postoperative dysphagia. [2022]

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]

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]

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

Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair. [2022]

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

Hiatal hernia repair with biosynthetic mesh reinforcement: a qualitative systematic review. [2023]

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]