Not yet recruitingNAINTERVENTIONAL

Assessment of Intra-abdominal Pressure During the Perioperative Period of Hernia Repair

This study focuses on people having open surgery for a type of hernia called a midline incisional hernia. These hernias can develop after previous abdominal surgery and sometimes come back even after being fixed. The researchers want to measure the pressure inside the tummy during the operation. They believe that understanding these pressure changes might help surgeons improve the way they repair hernias, potentially making the repairs stronger and less likely to fail in the future. The study hopes to find a new way to measure and define "tension-free" repair, which is thought to lead to better long-term results for patients.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Nice

Enrolment target

Start

01 May 2026

Estimated completion

01 Jul 2028

Hernia Incisional

What is this study about?

Many people have tummy surgery every day, and sometimes, a hernia can develop where the cut was made. This is called an incisional hernia, and they're quite common, especially after certain types of operations. Even after these hernias are fixed, they can sometimes come back, which can be frustrating and upsetting for patients.

Doctors are always looking for better ways to repair hernias so they don't come back. Some surgeons try to fix hernias without putting too much "pull" or tension on the tissues, hoping this makes the repair stronger. However, it's been difficult to really measure this "tension" during surgery.

This study aims to discover a reliable way to measure the pressure inside your tummy during an open operation to fix a specific type of incisional hernia. By understanding these pressures, doctors hope to gain new insights into how different surgical techniques affect the body and, in the long run, improve hernia repairs for everyone.

Key takeaways

This study aims to find a better way to measure pressure during hernia surgery.
It's for people having open surgery for a specific midline incisional hernia.
The goal is to help improve future hernia repairs and reduce hernias coming back.
Participation involves special measurements taken during your already planned surgery.
It could help doctors understand how to make repairs stronger and more lasting.

Who may be eligible?

This study is looking for adults aged 18 or older who have a specific type of tummy hernia called a midline incisional hernia. This means the hernia is in the middle of your tummy and is a certain size, between 4 and 10 cm wide. Your doctor would likely have mentioned this to you.

You must be planning to have open surgery to fix this hernia, where a mesh will be placed behind your tummy muscles. You also need to have national health insurance and be able to provide written permission (consent) to take part.

Unfortunately, you cannot join if you have other types of hernias, or if your hernia will be fixed using keyhole surgery or robotic surgery. If you are pregnant or breastfeeding, or if you are unable to give consent yourself (for example, if you have a legal guardian), you also won't be able to participate.

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.

Are you 18 years old or older?
Do you have a midline incisional hernia between 4 and 10 cm wide?
Are you scheduled for open surgery to fix your hernia with a mesh?
Are you NOT pregnant or breastfeeding?
Are you able to give written permission to join?

Answer every question to see your result.

What does participation involve?

As this study focuses on understanding measurements during surgery, participating mainly involves the routine care you would receive for your hernia operation. The main extra step would be during your planned open surgery for your midline incisional hernia, where specific measurements of abdominal pressure would be taken. This would be done by the surgical team as part of the study protocol. You would also need to provide written informed consent before the surgery. The study's focus is on the surgical procedure itself and gathering data during that time.

Potential risks and benefits

The main benefit of taking part is that the information gathered could help improve how incisional hernias are repaired in the future, potentially leading to better outcomes for other patients. As the study mainly involves taking measurements during your already planned surgery, the risks are generally low and associated with the standard surgical procedure itself. There are no new medications or untested procedures involved. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

CHU de Nice
Verified postcode
Nice, France

Common questions

What kind of hernia is this study about?

This study focuses on a specific type of hernia called a midline incisional hernia, which happens in the middle of your tummy after previous surgery.

What will happen during the study?

During your planned open hernia surgery, doctors will take specific measurements of the pressure inside your tummy.

Will taking part change my surgery?

No, you will still have your planned open hernia surgery. The study involves taking extra measurements during this procedure.

How long will I be involved in the study?

Your direct involvement in the study mainly happens during your single surgical procedure.

Can I still get my hernia fixed if I don't join the study?

Absolutely. Your decision to participate or not will not affect the medical care you receive for your hernia.

How to find out more

Damien MASSALOU, MD PhD

massalou.d@chu-nice.fr +33492032264 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.