Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap)
This study is about a new type of mesh, called 4DMESH®, used during keyhole surgery to fix hernias in the groin, specifically inguinal and femoral hernias. We want to understand how well this new mesh works and if it's safe for patients. Researchers will follow up with people who have this surgery to see if their hernia comes back, how much pain they experience, and how quickly they can return to their daily activities and work. We'll also look at their overall quality of life and any other symptoms they might have in their groin. This helps us ensure that the 4DMESH® is a good option for people needing hernia repair.
At a glance
What is this study about?
When you have a hernia in your groin, it means that a part of your insides has pushed through a weak spot in your tummy muscles. This can cause a bulge and sometimes pain. Surgery is often needed to fix this, and a special material called "mesh" is commonly used to strengthen the weak area and help prevent the hernia from coming back.
This study is looking at a new kind of mesh called 4DMESH®. It's designed to be used during a type of keyhole surgery for hernias in the groin. Keyhole surgery uses small cuts and special instruments, which often means a quicker recovery compared to traditional open surgery.
The main aim of this study is to check how safe and effective this new 4DMESH® is. Researchers will carefully watch a group of people who have this mesh implanted to see if their hernia comes back, how much pain they have, and how it affects their daily life and ability to work. They will also keep an eye on any side effects or problems that might happen after the surgery. This information will help doctors understand if 4DMESH® is a good choice for repairing hernias.
Key takeaways
- This study evaluates a new 4DMESH® for groin hernia repair.
- It uses keyhole surgery techniques.
- Researchers will check for hernia recurrence, pain, and recovery.
- Participation involves surgery and follow-up appointments.
- It aims to improve hernia repair outcomes for patients.
Who may be eligible?
To be part of this study, you need to have a new hernia in your groin, either on one side or both, that your doctor thinks can be fixed with keyhole surgery. You also need to be 18 years old or older and generally in good health, meaning you don't have very serious health problems that would make surgery too risky.
You cannot join if you've already had surgery for the same hernia before and it's come back. Also, if you need a different type of surgery called the Lichtenstein technique, or if you're allergic to the materials used in the 4DMESH®, this study wouldn't be right for you. People with active infections, a very short life expectancy, or who are pregnant also cannot take part.
Finally, you need to be able to understand what the study involves and agree to take part, as well as be able to come to all the follow-up appointments. If you're currently in another study or have been in one very recently, you might not be able to join this one.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Do I have a new hernia in my groin (not one that has come back)?
- Am I at least 18 years old?
- Am I generally in good health and able to have surgery?
- Am I prepared to attend follow-up appointments?
- Am I not pregnant?
- Do I understand what the study involves and agree to take part?
What does participation involve?
If you decide to take part, you'll first have to read and sign a consent form, which explains everything about the study. You will then have your hernia repaired using the new 4DMESH® in keyhole surgery. After the surgery, you'll have regular check-ups with the study team. These visits will check how you're recovering, if you're experiencing any pain, and if your hernia has returned. We'll also ask questions about your quality of life and how quickly you're getting back to your normal activities, including work. The study will involve collecting information from these appointments over a period of time, though the exact duration isn't specified, it usually means several months to a year or more.
Potential risks and benefits
Locations (9)
- Ziekenhuis Oost-Limburg GenkVerified postcodeGenk, Belgium
- Regionaal Ziekenhuis Heilig Hart TienenVerified postcodeTienen, Belgium
- AZ GroeningeVerified postcodeKortrijk, Belgium
- Hôpital Lyon Sud, Hospices Civils de LyonVerified postcodeLyon, France
- CHU de NantesVerified postcodeNantes, France
- CHU de ReimsVerified postcodeReims, France
- CH de TourcoingVerified postcodeTourcoing, France
- Hospital Universitario Virgen MacarenaVerified postcodeSeville, Spain
- Hospital Viamed Santa Ángela de la Cruz en SevillaVerified postcodeSeville, Spain
Common questions
What is an inguinal or femoral hernia?
These are types of hernias that happen when a part of your bowel pushes through a weak spot in the muscles in your groin area, creating a bulge.
What is 4DMESH®?
It's a new, specially shaped type of mesh material placed during surgery to strengthen the weak area where a hernia has occurred.
What is 'keyhole surgery'?
This is a way of doing surgery using very small cuts and special cameras and tools, often leading to a faster recovery than traditional open surgery.
Will I get special treatment if I join the study?
You will receive the hernia repair with the new mesh and be carefully monitored through regular follow-up appointments, but it's not 'special treatment' beyond the study's requirements.
Can I leave the study if I change my mind?
Yes, you are free to withdraw from the study at any time without giving a reason, and it won't affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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