RecruitingNAINTERVENTIONAL

The Impact of Abdominal Wall Closure Technique on Incidence of Incisional Hernia in Kidney Transplantation

This study aims to discover if a new way of stitching up the cut made during a kidney transplant can lower the chance of developing a hernia. A hernia is a bulge that can appear in the scar and can cause discomfort or serious problems. Transplant patients are more likely to get hernias because of their illness and the medicines they take. Researchers will compare current stitching methods with using smaller, more numerous stitches which might make the wound stronger. They will also collect blood and tissue samples to understand why some people get hernias. The goal is to improve recovery and reduce complications for kidney transplant patients.

At a glance

Status

Recruiting

Phase

Sponsor

Manchester University NHS Foundation Trust

Enrolment target

Start

10 Mar 2020

Estimated completion

30 Jun 2026

Surgery--Complications

What is this study about?

When you have a kidney transplant, surgeons make a cut in your tummy. After the operation, sometimes a bulge, called an incisional hernia, can appear in the scar. This can be uncomfortable, look unsightly, and in some cases, can lead to serious health problems if parts of your bowel or even the new kidney get trapped. People who have had kidney transplants are especially prone to these hernias, partly due to the illness that damaged their kidneys and partly because of the medicines they need to take, which can affect wound healing.

This study wants to find out if using a different way of stitching up the wound might help prevent these hernias. Instead of the usual, slightly larger stitches, surgeons would use smaller, more numerous stitches. This approach has shown promise in other types of surgery for making wounds stronger and reducing hernias, but it hasn't been properly tested for kidney transplants yet. If successful, this new stitching method could make a real difference in preventing problems for transplant patients.

The researchers will also collect small samples of blood and tissue from both kidney donors and the people receiving the kidneys. They want to look closely at these samples under a microscope to understand what might make someone more likely to develop a hernia. By combining what they learn from the stitching methods and the samples, they hope to get a much clearer picture of how to reduce hernias and improve the long-term health and comfort of people undergoing kidney transplants.

Key takeaways

Aims to reduce hernias after kidney transplants.
Compares two different ways of stitching wounds.
Collects blood and tissue samples to understand hernia risk.
Could improve comfort and health for transplant patients.
Involves answering questions about pain and quality of life over one year.

Who may be eligible?

To be able to take part in this study, you would generally need to be a patient who is having a kidney transplant because your own kidneys have failed. You would need to be between 18 and 70 years old, and this should be your first or second kidney transplant. It's also important that your body mass index (BMI) is less than 35.

Another key requirement is that you can understand English well enough to fully understand what the study involves and give your permission to participate. The study also includes people who are donating a kidney to someone else (living donors).

However, you wouldn't be able to join if you are outside the age range, have had previous transplants that left a scar in the specific area where the new kidney will be placed (called the iliac fossa), or if you are unable to understand English or give your consent.

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 having a kidney transplant for kidney failure?
Are you between 18 and 70 years old?
Is this your first or second kidney transplant?
Can you understand English and give your consent?
Is your BMI (Body Mass Index) less than 35?

Answer every question to see your result.

What does participation involve?

If you join this study, your surgeon will either use the standard stitching method for your kidney transplant wound or try a new method with smaller stitches. You won't know which method you received, but this is normal for this type of research. After your surgery, the research team will ask you to provide blood and a small tissue sample. You will also be asked some questions about any pain you're experiencing and your general quality of life at one week, six months, and one year after your operation. There are no extra hospital visits required, as these checks will happen during your routine follow-up appointments. The total duration of your active participation will be about one year.

Potential risks and benefits

Taking part in this study may offer the potential benefit of helping researchers find a better way to prevent hernias after kidney transplants, which could improve outcomes for future patients. For you personally, there's a chance the new stitching method might reduce your risk of a hernia, but this is what the study aims to discover. Potential risks are generally low, as the stitching methods are both standard surgical practices with slight variations. Giving blood and tissue samples carry minimal risks, like slight discomfort or bruising. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Manchester University NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is an incisional hernia?

It's a bulge that can appear in your surgical scar after an operation, sometimes causing discomfort or other problems.

Why are transplant patients more likely to get hernias?

The diseases causing kidney failure and the medicines used after transplant can affect wound healing, making hernias more common.

Will I know which stitching method was used on me?

No, you won't know, as this helps ensure the study results are fair and unbiased.

What kind of samples will be collected?

Small samples of blood and tissue will be collected to help understand why some people get hernias.

How long will I be involved in the study?

Your participation will involve follow-up checks during your routine appointments for about one year after your transplant.

How to find out more

Alex Shaw

alex.shaw@mft.nhs.uk +441617012066 Official trial record

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