RecruitingInterventional

Duramesh versus suture for prevention of port-site hernia after keyhole surgery

This research is looking into a significant issue after keyhole surgery: hernias forming at the site where instruments were inserted. Currently, about one in four people develop these 'port-site hernias' even with standard stitches. This study compares a new product called Duramesh with traditional stitches to see if Duramesh can lower this rate. Adults having keyhole surgery for general conditions in the NHS are invited to join. Half will receive Duramesh, and half standard stitches. Researchers will follow participants for two years to check for hernias using ultrasound scans and monitor other health aspects. The study hopes to find a better way to prevent hernias, potentially saving patients from more operations.

At a glance

Status

Recruiting

Sponsor

Croydon Health Services NHS Trust

Enrolment target

250

Start

09 Jun 2025

Estimated completion

09 Dec 2026

Duramesh versus conventional suture closure for laparoscopic periumbilical trocar sites

What is this study about?

When you have keyhole surgery, doctors make small cuts in your tummy. To do this, they use tubes called 'trocars' to get their instruments inside. After the operation, these small cuts need to be closed carefully. The main strength-holding layer around your tummy muscles, called the 'fascia', is usually sewn up with stitches. Even with these stitches, around one in four people can still get a hernia at the operation site, which is called a 'port-site hernia'. This can sometimes lead to more surgery down the line.

This study, called TROCAR, wants to see if a newer product, Duramesh, is better than standard stitches at stopping these hernias. Duramesh is designed to provide strength during the healing process. If it works better, it could mean fewer people need further operations for hernias and could improve recovery after keyhole surgery. The research will carefully compare how both methods perform.

Taking part would mean you're helping doctors understand the best way to close these surgical sites. It's an important step towards improving care for many people having keyhole surgery in the future.

Key takeaways

Compares Duramesh vs. standard stitches for preventing hernias after keyhole surgery.
Adults having general keyhole surgery are eligible.
Participation involves either Duramesh or standard stitches, chosen randomly, plus follow-up appointments.
Follow-up includes ultrasound scans for hernias at 3 months, 1 year, and 2 years.
Potential benefit: a reduced risk of hernia; potential risk: Duramesh is a permanent material.
The study aims to find a better way to close surgical cuts and reduce the need for future operations.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) who is having keyhole (laparoscopic) surgery for a general medical condition. This surgery must involve a specific type of cut near your belly button for the camera or other instruments, which is at least 10mm wide.

We also need to make sure you can understand what the study involves and are happy to give your permission to take part, and that you'll be able to attend follow-up appointments. If you happen to have a small umbilical hernia at the same time and it's repaired during the main surgery, you might still be able to participate.

However, you can't join if you're pregnant, have a very high BMI (over 40), or are having certain types of keyhole surgery like gynaecological or urological procedures. Also, if there's any reason your doctor thinks it wouldn't be safe or suitable for you to take part, based on your other medical history, then you wouldn't be able to join.

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?
Are you having 'keyhole' surgery for a general medical condition?
Can you provide written consent and attend follow-up appointments for 2 years?
Are you *not* pregnant, and is your BMI not above 40?
Is your planned operation *not* for gynaecological or urological issues?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, during your keyhole operation, half of the people will have their surgical cut closed with Duramesh, and the other half will have standard stitches. You won't know which one you receive, and neither will the people checking for results, so it's a fair comparison. Apart from this closing method, your operation will be exactly the same as if you weren't in the study.

After your surgery, you'll have three follow-up appointments: one at 3 months, another at 1 year, and a final one at 2 years. At each of these check-ups, you'll have an ultrasound scan around your belly button to see if a hernia has formed. The study will also keep an eye on how your wound heals, if you need any other operations, how long you stay in hospital, and your general quality of life after surgery. The total study duration for you would be 2 years.

Potential risks and benefits

Participating in this study might offer a benefit if Duramesh proves to be more effective, potentially lowering your chances of getting a port-site hernia within two years, and possibly for longer. This could mean you avoid needing another operation in the future for a hernia. However, there are also some potential risks to consider. Duramesh is a material that stays in your body permanently, similar to some other mesh products used for hernias. We don't fully know how this might affect your body long-term, but any complications would likely be similar to those seen with standard permanent stitches. Being part of this study is entirely your decision, and you have the right to withdraw at any time without it affecting your medical care.

Locations (1)

Croydon University Hospital
Approximate
Croydon, England

Common questions

What is a port-site hernia?

It's a type of hernia that can happen at one of the small cuts made during keyhole surgery, where instruments were inserted.

What is Duramesh?

Duramesh is a new product being tested to see if it's better than standard stitches at closing the surgical cuts after keyhole surgery and preventing hernias.

Will I know if I get Duramesh or standard stitches?

No, you won't know which method was used, and neither will the doctors checking for hernias. This helps make the study results as fair as possible.

How long will I be involved in the study?

You'll be followed up for two years after your keyhole surgery, with appointments at 3 months, 1 year, and 2 years.

Who is paying for this research?

The study is funded by Eurosurgical Ltd.

How to find out more

Lawrence Nip

l.nip@nhs.net +44 (0)7840059436 Official trial record

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