Active not recruitingNAINTERVENTIONAL

Mesh Augmented Reinforcement of Abdominal Wall Suture Line to Limit the Rate of Incisional Hernia Occurrence

This study is looking at a new type of dissolvable mesh, called Deternia™ Self-Gripping Resorbable Mesh. It's designed to be used after a common type of tummy (abdominal) surgery where doctors make a cut down the middle of your stomach, called a midline laparotomy. The mesh helps to strengthen the area where the doctors have made stitches. The main goal is to see if this mesh can prevent a problem called an incisional hernia, which is when tissue pushes through the weakened surgical scar. We'll be watching how well patients recover and if hernias occur over several years. The study will also check to make sure the mesh is safe. The results will help decide if this mesh can be widely used in the future.

At a glance

Status

Active not recruiting

Phase

Sponsor

Medtronic - MITG

Enrolment target

123

Start

22 Nov 2022

Estimated completion

01 Nov 2030

Incisional Hernia Incisional Hernia of Midline of Abdomen Midline Laparotomy

What is this study about?

When you have surgery on your tummy, doctors sometimes need to make a cut down the middle. This is called a midline laparotomy. After the operation, they close the cut with stitches. However, sometimes the stitches can weaken, and a bulge can push through the scar area. This is called an incisional hernia. It's a common problem, and doctors are always looking for better ways to prevent it.

This study is testing a new product called Deternia™ Self-Gripping Resorbable Mesh. Think of it as a special dissolvable fabric that surgeons can place inside your tummy to strengthen the area where they've made their stitches. The idea is that this extra support will help stop incisional hernias from happening. Because the mesh is dissolvable, it disappears over time once your body has healed.

The main purpose of this study is to see how well this mesh works to prevent hernias after one year, compared to what we'd normally expect. We also want to check if it's safe to use over a longer period, up to five years. The information we gather will help doctors understand if this new mesh is a good option for patients having this type of tummy surgery in the future.

Key takeaways

This study tests a new dissolvable mesh to prevent hernias after tummy surgery.
It aims to make surgical areas stronger and safer.
Participation involves follow-up appointments for up to five years.
Researchers will check how well the mesh works and if it's safe.
You must be 18 or over and having a specific planned tummy operation.

Who may be eligible?

To join this study, you need to be at least 18 years old and be planning to have a specific type of elective (meaning planned, not emergency) tummy surgery where the doctor makes a cut down the middle of your stomach. This includes if you're having keyhole surgery that might need to be converted to a larger cut, or if a larger cut is needed to remove something.

There are also some reasons why you might not be able to join. For example, if you're having emergency surgery, or if you've had a serious allergic reaction to similar materials in the past. If you're pregnant, planning to get pregnant, or breastfeeding during the study, you also can't take part. We also can't include people with certain health conditions like uncontrolled diabetes or a very high body mass index (BMI over 45).

Other exclusions include if you've had similar mesh placed before, have a large existing hernia, or if your life expectancy is less than the study's follow-up period (about three years). If you can't come to follow-up appointments or have another surgery planned that might affect this study, you wouldn't be able to join either.

Quick self-check

Am I 18 years old or older?
Am I having a planned tummy operation where the surgeon might make a cut down the middle of my stomach?
Am I NOT pregnant, breastfeeding, or planning either during the next few years?
Do I have any serious medical conditions like uncontrolled diabetes or a very high BMI (over 45)?

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

What does participation involve?

If you decide to take part, you'll have the Deternia™ mesh placed during your planned tummy surgery. After the operation, the study team will ask you to come for several follow-up appointments over five years. During these appointments, they will check your recovery, look for any signs of hernias, and make sure you're feeling well. They might ask you questions about your health and do physical examinations. This is to monitor how the mesh is performing and to ensure your safety for several years after your surgery.

Potential risks and benefits

The potential benefits of taking part could include a reduced chance of developing an incisional hernia after your surgery, which could mean less pain and fewer future surgeries. However, because this is a new type of mesh, there's a chance it might not work as well as hoped, or it could have side effects that we don't fully know about yet. All surgeries carry risks, and adding a mesh might introduce new or different ones, though these will be carefully monitored. You are free to withdraw from the study at any time without affecting your medical care.

Locations (13)

Clinical Hospital Center Sisters of Mercy
Zagreb, Croatia
University Hospital Center of Zagreb
Zagreb, Croatia
Klinikum Braunschweig
Braunschweig, Germany
Pius-Hospital Medical Campus University of Oldenburg
Oldenburg, Germany
Barmherzige Brüder Regensburg
Regensburg, Germany
IJsselland Ziekenhuis
Capelle aan den IJssel, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Consorci Sanitari de l'Anoia Hospital Universitari d'Igualada
Igualada, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Countess Of Chester Hospital NHS Foundation Trust
Chester, United Kingdom

+1 more sites — see the official record for the full list.

Common questions

What is an incisional hernia?

It's when a small bulge appears near a surgical scar on your tummy because tissue pushes through weakened muscle or stitches.

What is Deternia™ mesh?

It's a special dissolvable mesh placed in your tummy during surgery to strengthen the area and help prevent hernias.

How long will I be in the study?

You'll be followed up for a total of five years after your surgery to check on your recovery and the mesh's performance.

Is the mesh permanent?

No, it's 'resorbable', which means it slowly dissolves in your body after it has provided support for healing.

What kind of surgery do I need to be having?

You need to be having a planned (elective) midline laparotomy, which is a specific type of cut down the middle of your tummy.