RecruitingNAINTERVENTIONAL

VirtuAl Technology to Improve the Management of Perianal Crohn's (VAMP) - PROSPECTIVE

This study is testing a new computer tool called vEUA to help people with Crohn's disease who have problems around their back passage, like fistulas (unusual tunnels) or abscesses (pockets of infection). Currently, surgeons often rely on written reports and their own examination, which can be tricky. The vEUA tool creates a 3D picture of the problem from MRI scans, giving surgeons a clearer view before an operation. We hope this will help surgeons treat the problem more effectively, potentially leading to fewer operations, better healing, and less risk of future issues like difficulties controlling bowel movements. Participants will either receive care with this new tool or standard care.

At a glance

Status

Recruiting

Phase

Sponsor

Nottingham University Hospitals NHS Trust

Enrolment target

Start

23 Jul 2024

Estimated completion

07 Sep 2026

Perianal Crohns Disease

What is this study about?

Crohn's disease is a condition that causes inflammation in your gut. For many people, it can also lead to issues around the back passage, like fistulas, which are small tunnels that shouldn't be there, or abscesses, which are pockets of infection. These can be very painful and hard to treat, sometimes needing surgery. Surgeons try to fix these problems to control infection, but it can be difficult to see everything clearly, which might lead to more operations or a delay in proper treatment. In some cases, repeated operations could even affect the muscles that control your bowels.

Currently, when you have an MRI scan, a specialist doctor (a radiologist) writes a report describing what they see. These reports can be very technical and sometimes hard for surgeons to fully picture in their minds, especially for complex 3D problems. This new study is looking at a clever computer tool called vEUA. This tool takes the information from your MRI scan and turns it into a detailed 3D image of the area around your back passage. Imagine being able to see a precise, interactive map of the problem before any surgery even begins.

The main idea behind vEUA is to give surgeons a much clearer understanding of the fistulas and abscesses. We believe that if surgeons have this better view, they'll be able to plan and carry out operations more effectively. This could mean they can deal with all the issues in one go, avoiding the need for multiple operations. Ultimately, this approach aims to reduce discomfort, help you heal faster, and lower the risk of unwanted side effects like problems controlling your bowels. This study helps us find out if this new technology really makes a difference.

Key takeaways

New 3D imaging tool (vEUA) tested for perianal Crohn's.
Aims to help surgeons understand complex problems better.
Could lead to fewer operations and better healing.
Compares vEUA use to standard care (written MRI reports).
Participation involves questionnaires and data from your planned surgery.
Helps advance understanding of Crohn's treatments.

Who may be eligible?

To take part in this study, you would generally need to be an adult between 18 and 75 years old and have Crohn's disease that's causing problems like fistulas or abscesses around your back passage. A doctor must have already decided that surgery is needed for this problem. You also need to be able to understand the study and agree to take part.

There are also some reasons why you wouldn't be able to join. For instance, if you've had a major operation to remove your rectum (part of your bowel), or if your back passage issues are not due to Crohn's. We also can't include people with certain other serious health conditions, or if you're pregnant or breastfeeding. If you can't have an MRI scan, for example, due to a pacemaker, you also wouldn't be able to participate. Also, if you’re already in another research study, you wouldn’t be eligible.

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 between 18 and 75 years old?
Do you have Crohn's disease affecting your back passage (fistulas/abscesses)?
Has your doctor decided you need surgery for this issue?
Are you able to provide consent and understand the study?
Are you NOT pregnant or breastfeeding?
Can you have an MRI scan (no pacemaker, for example)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance to one of two groups. One group will have their surgeons use the new 3D vEUA tool to plan their care, and the other group will receive standard care, where surgeons use the usual written MRI reports. You won't know which group you are in.

Before and after your surgery, you’ll be asked to fill out some questionnaires about your symptoms and how you're feeling. The medical team will also gather information from your surgical procedure and any MRI scans you have. All of this helps us compare how effective the new tool is compared to standard care. This study involves your usual planned surgery and appointments; there won't be extra hospital visits just for the study. The total duration of your participation would depend on your recovery and follow-up but would fit within your normal medical care timeframe.

Potential risks and benefits

Taking part in this study could offer the benefit of potentially better-planned surgery and improved healing if you're in the group using the new 3D tool. For everyone, regardless of the group, your participation helps us learn more about the best ways to treat Crohn's disease. There are no additional physical risks beyond those normally associated with your planned surgery and MRI scans. You are free to withdraw from the study at any time without it affecting your usual medical care.

Locations (1)

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

Nottingham University Hospital NHS Trust
Verified postcode
Nottingham, United Kingdom· Recruiting

Common questions

What is a 'fistula'?

A fistula is an unusual tunnel that forms between two parts of your body, like between your bowel and your skin, often near the back passage in Crohn's disease.

What is 'standard care'?

Standard care means the usual treatment and procedures that doctors currently use for your condition, without involving new experimental tools like vEUA.

Will I definitely get the new 3D tool (vEUA)?

No, you will be randomly assigned to either the group whose surgeons use the vEUA tool or the group receiving standard care. It's like flipping a coin for fairness.

What is the 'reading age' of 12-14?

It means the information is written in simple, clear language that someone aged 12 to 14 could easily understand, avoiding complicated medical words.

Will this study cure my Crohn's disease?

This study aims to improve how your perianal Crohn's disease is managed and treated, potentially leading to better outcomes. It's not a cure for Crohn's disease itself.

How to find out more

Jonathan Paul Evans, MBChB PhD FRCS

nuhnt.researchsponsor@nhs.net +44115 924 9924 Official trial record

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