RecruitingObservational

Informing the design of a clinical trial into umbilical hernia repair

This study aims to help plan a larger clinical trial about the best way to fix an umbilical hernia, which is a swelling around the belly button. Sometimes these hernias get stuck or cause pain, needing emergency surgery. Currently, surgeons have different opinions on the best repair methods. Before running a big trial to compare these methods, we need to understand how easy it will be to find enough patients and if surgeons will be willing to use different repair techniques. We're asking 50-100 patients having emergency hernia surgery to answer some questions about their symptoms and recovery. This study won't change your medical care but will help us design a better trial in the future to find the best treatment for umbilical hernias.

At a glance

Status

Recruiting

Sponsor

University of Birmingham

Enrolment target

100

Start

01 May 2025

Estimated completion

31 Aug 2026

Surgery

What is this study about?

Imagine you have a swelling near your belly button – that's an umbilical hernia. Sometimes, these hernias can become trapped or painful, requiring an emergency operation. Right now, doctors don't all agree on the very best way to fix these hernias, and we need more research to find the most effective treatment.

This study, called ASTEROID, isn't a trial to test a new treatment itself. Instead, it's a very important step to help us design a future, bigger trial. Think of it like a practice run or a planning stage. We need to figure out how long it might take to find enough patients for a larger study and whether surgeons would be happy to try different ways of fixing the hernia if chosen by chance. By gathering this information now, we can make sure the future main trial is well-organised and successful.

We're asking between 50 and 100 people who are having emergency surgery for their umbilical hernia to take part. This will help us answer our questions and ensure that when the main trial happens, it gives us clear answers about the best way to treat umbilical hernias, ultimately benefiting many people in the future.

Key takeaways

This study helps plan a future trial, not treat your hernia.
Your medical care won't change if you participate.
You'll complete a few questionnaires over about a month.
There are no direct benefits to you, but it helps future patients.
There are no health risks from taking part.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 or over who need an emergency operation for a specific type of umbilical hernia. This means your hernia is currently stuck, trapped, or causing a blockage.

There are a few reasons why someone might not be able to join. If you are pregnant, you won't be able to take part because pregnancy changes how your body's abdominal wall works. Also, if you have a liver condition called cirrhosis, you won't be eligible as this can affect how your body recovers from surgery.

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 emergency surgery for an umbilical hernia?
Is your umbilical hernia currently stuck, trapped, or causing a blockage?
Are you NOT pregnant?
Do you NOT have a liver condition called cirrhosis?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your medical care for the hernia won't change; your surgeon will fix your hernia in the way they usually would. Before your operation, we will ask you to fill out two short questionnaires about your quality of life and your hernia symptoms. After your surgery, we'll get in touch by email at 7 days and 30 days later. You'll be asked to complete the same questionnaires again, plus a third one about how your wound is healing. We will also collect some details about your hernia and the operation from your medical notes.

We will also have a chat with your surgeon after your operation. We'll pretend to pick a repair method and an option for antibiotics for you. We'll then ask your surgeon whether they would have happily used that method or chosen those antibiotics in a real trial. This is a theoretical exercise and won't affect your actual treatment. The whole process, from the first questionnaires to the last, will last about a month after your surgery.

Potential risks and benefits

There are no direct personal benefits for you by taking part in this study. However, your participation is incredibly valuable as it will help us gather important information to design a future, larger study that aims to find the best treatment for umbilical hernias. This could benefit many people with similar conditions in the future. There are no health risks to participating because the study does not change how your hernia is treated by your doctors. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (7)

Queen Elizabeth Hospital
Approximate
Birmingham, England
Queen Alexandra Hospital
Approximate
Portsmouth, England
Arrow Park Hospital
City only
Wirral, England
Musgrove Park Hospital
Approximate
Taunton, England
Yeovil District Hospital
City only
Yeovil, England
Homerton University Hospital
Approximate
London, England
St James' S University Hospital
Approximate
Leeds, England

Common questions

What is an umbilical hernia?

It's a swelling near your belly button that can happen when part of your bowel or fat pushes through a weak spot in your tummy muscles.

Will my hernia be fixed differently if I join this study?

No, absolutely not. Your surgeon will still fix your hernia using the method they believe is best for you, just like if you weren't in the study.

What do I need to do if I take part?

You'll fill in a few short questionnaires before and after your surgery, over about a month. That's all.

Will I get any special treatment?

No, your medical care will be exactly the same whether you join the study or not. There are no direct benefits for you personally.

Who is paying for this study?

The study is funded by the British Hernia Society.

How to find out more

Michala Pettitt

bhamred@contacts.bham.ac.uk - Official trial record

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