Active not recruitingOBSERVATIONAL

Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application

This study, called SYN 20-01, is designed to learn more about how a medical device called GORE® SYNECOR Biomaterial performs during and after hernia repair surgery. It's not a study where you'd be trying a new, untested treatment, but rather observing how this specific mesh works in real-world settings. Doctors will follow adult patients (aged 18 to 80) in both the UK/Europe and the US who are having surgery for certain types of hernias. The main goal is to see how effective and safe this mesh is over a long period, specifically five years. They are interested in people with ventral or incisional hernias, which are types of hernias that can happen in the tummy area, especially after a previous surgery.

At a glance

Status

Active not recruiting

Sponsor

W.L.Gore & Associates

Enrolment target

320

Start

24 Feb 2023

Estimated completion

31 Jul 2030

Hernia, Ventral Hernia Incisional Hernia Incisional Ventral

What is this study about?

This study is called SYN 20-01 and it's looking at a specific type of surgical mesh called GORE® SYNECOR Biomaterial. Hernias happen when an organ or fatty tissue squeezes through a weak spot in a muscle or tissue. This study focuses on hernias in the tummy area, known as ventral or incisional hernias, which often occur after previous surgery. When a hernia is repaired, surgeons sometimes use a mesh to help strengthen the weakened area and prevent the hernia from coming back.

This study isn't about testing a new medicine or a brand-new surgical technique. Instead, it's observing how the GORE® SYNECOR mesh works for patients in different medical centres in the UK/Europe and the US after it's already been approved for use. Researchers want to understand how it performs over a long time, specifically five years, for people with different kinds of hernias that can be fixed with this mesh.

The main aim is to gather information on how well the mesh helps patients recover, how strong the repair stays, and if there are any long-term issues. This information will help doctors understand more about using this mesh for hernia repairs, ensuring they can make the best choices for their patients in the future.

Key takeaways

This study observes the long-term results of using GORE® SYNECOR mesh for hernia repair.
It focuses on ventral and incisional hernias in the tummy area.
Participants will be followed for five years after their surgery.
It’s an observational study, meaning you have regular check-ups, not extra treatments.
The mesh is a standard, approved device, not an experimental one.
You must be an adult (18-80) with a 'clean' wound at the time of surgery.

Who may be eligible?

To be considered for this study, you would need to be an adult between the ages of 18 and 80. You would also need to be having surgery to fix a new or returning ventral or incisional hernia in your tummy area, and your surgeon must plan to use the GORE® SYNECOR mesh as part of your repair. Importantly, your wound must be considered 'clean' – meaning there are no signs of infection at the time of your surgery.

There are also a couple of ways your hernia will be assessed by the medical team. They will look at the size and complexity of your hernia to make sure it fits a certain category, often called 'Grade 1 or 2' which refers to smaller or medium-sized hernias. This helps make sure the study groups are similar.

You would not be able to join the study if your surgical wound is already infected, or if it's considered to have a higher risk of infection for other reasons, such as during surgery involving certain parts of the gut. This is because the study specifically wants to look at how the mesh performs in patients with clean surgical sites.

Quick self-check

Are you between 18 and 80 years old?
Are you having surgery for a ventral or incisional hernia?
Will your surgeon be using GORE® SYNECOR mesh for your repair?
Is your surgical wound expected to be clean (no infection) during the operation?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, it's considered an 'observational' study. This means you will receive your hernia repair surgery as planned by your surgeon, and the GORE® SYNECOR mesh will be used. The study doctors will then simply follow your progress for five years after your surgery. This will involve scheduled check-ups, where they will gather information about your health, how well your hernia repair is healing, and if you experience any problems.

These check-ups will usually happen at certain times after your surgery, for example, a few months later, and then once a year, up to the five-year mark. There are no additional medications or experimental treatments involved in this study beyond your standard hernia repair with the chosen mesh. The main commitment is attending these follow-up appointments so the doctors can collect important information about your long-term recovery.

Potential risks and benefits

Taking part in this study means doctors will closely monitor your recovery after your hernia repair for five years, which could provide you with a high level of follow-up care. The mesh being studied is already approved for use, so you wouldn't be receiving an experimental treatment. However, as with any surgery, there are potential risks associated with hernia repair and mesh, such as infection, pain, or the hernia returning, which would be explained by your surgeon. You are free to withdraw from the study at any time without affecting your medical care.

Locations (15)

Emory Saint Joseph's Hospital
Atlanta, United States
Tufts Medical Center
Boston, United States
Corewell Health
Grand Rapids, United States
Lovelace Women's Hospital
Albuquerque, United States
Stony Brook University Hospital
Stony Brook, United States
Novant Health New Hanover Regional Medical Center
Wilmington, United States
Prisma Health Greenville Memorial Hospital
Greenville, United States
Bon Secours Memorial Regional Medical Center
Mechanicsville, United States
Ospedale Civile di Baggiovara
Baggiovara, Italy
Vincenzo Monaldi Hospital
Naples, Italy
Sapienza Università di Roma
Roma, Italy
University Hospital Virgen Macarena - Department of General And Digestive Surgery
Seville, Spain

+3 more sites — see the official record for the full list.

Common questions

What is a ventral or incisional hernia?

These are types of hernias that happen in your tummy area, often at the site of a previous surgical cut.

What is GORE® SYNECOR Biomaterial?

It's a special type of surgical mesh that surgeons use to help repair weakened areas during hernia surgery and strengthen the repair.

Will I get special treatment if I join this study?

Your hernia repair will be done as planned by your surgeon. The study involves regular check-ups to see how you are doing over five years.

How long will I be followed in this study?

You will be followed by the study team for a total of five years after your hernia repair surgery.

Can I leave the study if I change my mind?

Yes, you can decide to leave the study at any time, and this will not affect your medical care.