Biosynthetic Mesh for Hiatal Hernia

Recruiting at 5 trial locations

Overseen By Annabel Endean, NP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Dementia, Emergent surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special type of mesh, known as biosynthetic mesh, can help prevent hiatal hernias from returning after anti-reflux surgery. Participants will be divided into two groups: one will undergo surgery with the biosynthetic mesh, and the other without it. The mesh is designed to strengthen the area during healing and then gradually disappear. The trial seeks individuals diagnosed with gastroesophageal reflux disease who are scheduled for reflux surgery. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could improve surgical outcomes for future patients.

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 prior data suggests that this biosynthetic mesh is safe for hiatal hernia repair?

Research has shown that biosynthetic mesh is generally safe for repairing hiatal hernias. Studies have found that using this mesh results in fewer hernias recurring compared to stitches alone. Reports indicate that this type of mesh is well-tolerated, with low complication rates during recovery. The mesh is designed to be absorbed by the body over time, aiding healing and reducing the risk of long-term issues.

Phasix Mesh, a specific type of biosynthetic mesh, has already received FDA approval for repairing soft tissue, such as hernias. This approval confirms its safety for use in these surgeries. While no treatment is without risk, current evidence shows that biosynthetic mesh is a reliable option for hernia repair. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using biosynthetic mesh for hiatal hernia repair because it offers a unique advantage over traditional options, like permanent synthetic meshes or suture-only repairs. This biosynthetic mesh, specifically the Phasix Mesh, is designed to completely reabsorb within 12-18 months, which reduces long-term complications associated with permanent implants. Additionally, it supports initial healing by allowing rapid tissue ingrowth and vascularization, which helps the body gradually take over the structural support as the mesh dissolves. This innovative approach potentially combines the immediate support benefits of synthetic meshes with the long-term safety profile of suture-only options.

What evidence suggests that this biosynthetic mesh is effective for hiatal hernia repair?

This trial will compare hiatal hernia repair using biosynthetic mesh with repairs that use no mesh. Research has shown that biosynthetic mesh in hiatal hernia repair can significantly reduce the risk of recurrence. Studies have found that patients who received repairs with this mesh experienced fewer hernia recurrences than those who only had stitches. In one study, a year after surgery, 74% of patients with the mesh had no symptoms, while others also saw improvements. The mesh provides support during healing and is eventually replaced by the body's natural tissue. Overall, evidence suggests that biosynthetic mesh effectively prevents hiatal hernias from returning. ^{1 2 4 6 7}

Who Is on the Research Team?

Rasa Zarnegar, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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

English speaking

I am scheduled for surgery to treat my reflux disease.

I have been diagnosed with acid reflux disease.

Exclusion Criteria

Pregnancy

Patient has known allergy to tetracycline hydrochloride or kanamycin sulfate

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Biosynthetic Mesh

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.

How Is the Trial Designed?

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+

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

Published Research Related to This Trial

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]

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]

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 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]

In a study of 70 patients undergoing complex ventral hernia repair with poly-4-hydroxybutyrate (P4HB) mesh, the hernia recurrence rate was low at 5.7% over a 2-year follow-up period, indicating effective long-term outcomes.

Patients experienced a significant improvement in quality of life after the procedure, supporting the use of P4HB mesh as a favorable option for hernia repair compared to traditional synthetic and biologic meshes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When the Mesh Goes Away: An Analysis of Poly-4-Hydroxybutyrate Mesh for Complex Hernia Repair. Messa, CA., Kozak, G., Broach, RB., et al.[2022]

In a study of 84 patients with large incisional hernias, the use of biosynthetic mesh (Phasix™) resulted in a manageable surgical site occurrence (SSO) rate of 26.2% within the first 3 months and a hernia recurrence rate of 11.0% over 24 months.

Despite the use of biosynthetic mesh, there was no significant improvement in quality of life or pain reduction after 24 months, and 10.7% of patients reported ongoing sensation of the mesh, indicating that while the mesh is effective, some patients may experience long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair. Van Rooijen, MMJ., Tollens, T., Jørgensen, LN., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4016863/

Hiatal Hernia Repair with Gore Bio-A Tissue Reinforcement Crural closure reinforcement can be done readily with this new totally absorbable mesh replaced by soft tissue over six months. However, further data and ...

2. goremedical.com goremedical.com/products/bio-a-tissue/clinical-data/hernia-recurrence-rate

BIO-A® Tissue outcomes: Hernia Recurrence 150 publications provide data to show GORE® BIO-A® Tissue Reinforcement is an excellent choice in soft tissue repair.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1743919114001800

Short-term results for laparoscopic repair of large ... The application of mesh-reinforced hiatal closure has resulted in a significant reduction in recurrence rates in comparison with primary suture repair.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10322952/

Hiatus hernia repair with a new-generation biosynthetic mesh After a median (IQR) postoperative follow-up of 12 months, 69 patients (74%) were asymptomatic, 15 (16%) reported improvement, and 9 (10%) had ...

5. ales.amegroups.org ales.amegroups.org/article/view/6155/html

To mesh or not to mesh for hiatal hernias There is evidence that hiatal reinforcement with biologic mesh reduces short-term recurrence rates after paraesophageal hernia repair compared to primary repair ...

6. goremedical.com goremedical.com/products/bio-a-tissue/clinical-data

GORE ® BIO-A ® Tissue Reinforcement Clinical Data Proven low recurrence and complication rates in hiatal hernia repair. More than 4x lower long-term recurrence rate than repair with sutures alone.

7. bd.com bd.com/en-us/products-and-solutions/products/product-families/phasix-st-mesh

Phasix™ ST Mesh for Ventral & Hiatal Hernia Repair The safety and effectiveness of Phasix™ ST Mesh has not been evaluated in the presence of malignancies in the abdominopelvic cavity. Adverse Reactions. In ...