RecruitingNAINTERVENTIONAL

Evaluation of the Ileo-anal Pouch in FAP (ENDOPOL)

This study looks at adults with Familial Adenomatous Polyposis (FAP) who have had a specific type of surgery and now have an internal pouch. We want to compare two different ways doctors check for new growths (polyps) during their routine 'pouchoscopy' examinations. One method uses a special dye, and the other uses advanced camera technology. Doctors want to see which method is better at spotting these polyps. The results will help decide the best way to do these checks in the future, improving care for people with FAP and similar pouches. You'll have your usual check-up, and the method used will be chosen randomly, like flipping a coin for an equal chance.

At a glance

Status

Recruiting

Phase

Sponsor

London North West Healthcare NHS Trust

Enrolment target

Start

09 Jul 2026

Estimated completion

09 Jul 2031

Familial Adenomatous Polyposis (FAP)Pouches, Ileoanal

What is this study about?

This study is about people who have a condition called Familial Adenomatous Polyposis, or FAP. FAP means you have a higher chance of developing many growths, called polyps, in your large bowel. Many people with FAP have surgery to remove their large bowel, and often, doctors create an internal pouch to help them continue to pass waste normally. Even with this pouch, new polyps can sometimes grow inside it, or in the area just before or after it. Because of this, regular check-ups, called 'pouchoscopies', are very important to find any new polyps early.

At the moment, doctors use two main ways to look for these polyps during a pouchoscopy. One way involves spraying a special blue dye, like indigo carmine, inside the pouch to make the polyps stand out more clearly. The other way uses advanced camera technology built into the scope, sometimes called 'virtual chromoendoscopy' or NBI/BLI, which enhances the view without needing a dye. Both methods work, but doctors aren't sure which one is best at finding polyps most effectively. This study aims to compare these two methods side-by-side.

The main goal is to find out if one method is better at spotting polyps, especially very small ones, and if it helps doctors measure them more accurately. The results of this study will help standardise care across different hospitals and provide clear guidance for doctors on the best way to perform these important check-ups in the future. This means that future patients with FAP could receive even better and more consistent surveillance.

Key takeaways

This study compares two ways to check for polyps during routine pouchoscopies for FAP patients.
It aims to find the best method for future care.
Participation happens during your normal check-up, no extra appointments.
You'll be randomly assigned to one of two checking methods.
No extra risks beyond your usual procedure.
Your involvement helps improve care for FAP patients in the future.

Who may be eligible?

To be able to take part in this study, you need to meet a few key requirements. Firstly, you must be an adult, aged 18 or older. You also need to have a confirmed diagnosis of Familial Adenomatous Polyposis (FAP). This means either a genetic test shows you have the FAP gene, or you’ve had more than 100 growths (polyps) in your bowel and have a family history of FAP.

Crucially, you must also have had a specific type of surgery where your large bowel was removed, and an internal pouch was created to connect your small bowel to your bottom. This is sometimes called an ileo-anal pouch or IPAA. You will be identified through your regular hospital appointments for these pouch check-ups. Unfortunately, if you are not able to understand and agree to take part, you won't be able to join the study.

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 diagnosis of FAP (Familial Adenomatous Polyposis)?
Have you had surgery to create an ileo-anal pouch (IPAA)?
Are you able to understand and agree to take part in a study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be invited during your usual, planned pouchoscopy appointment. Before your procedure starts, a doctor or nurse will explain the study in more detail, answer any questions you have, and ask for your consent. If you agree, a computer will randomly decide whether you will have the check-up using the special dye or the advanced camera technology – it's like flipping a coin. You won't get to choose which method is used.

During the pouchoscopy, just like a normal procedure, the doctor will carefully look at your pouch and the surrounding areas. If any polyps are found that need to be removed, they will be taken out during the same procedure, following standard hospital practice. After your procedure, you'll go home as usual and monitor for any side effects, just like any routine pouchoscopy. There are no extra hospital visits or special medications for this study. The entire study observation for each participant happens during this single, routine appointment, and the overall study is expected to last about two years, gathering information from many patients.

Potential risks and benefits

Taking part in this study doesn't involve any extra risks beyond those of a standard, routine pouchoscopy which your doctors would be performing anyway. Both methods of checking for polyps (the dye or the camera technology) are established and safe. There's no direct personal benefit from taking part, as you'll receive your usual high standard of care. However, the information gathered will help doctors understand the best way to perform these checks, which could lead to better future care for many other patients with FAP and similar pouches. You are completely free to change your mind and withdraw from the study at any time, for any reason, without it affecting your care.

Locations (1)

St Mark's Hospital Polyposis Registry (St Mark's Centre for Familial Intestinal Cancer)
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is FAP?

FAP stands for Familial Adenomatous Polyposis. It's a genetic condition where you develop many growths (polyps) in your large bowel, which can become cancerous if not treated.

What is a pouchoscopy?

A pouchoscopy is a routine check-up where a doctor uses a thin, flexible tube with a camera to look inside your internal pouch (created after bowel surgery) and the surrounding areas to check for new polyps.

What are the two methods being compared?

One method uses a special blue dye sprayed inside the pouch to highlight polyps. The other uses advanced camera technology built into the scope that enhances the view without needing a dye.

Will I get to choose which method is used for my check-up?

No, if you join the study, a computer will randomly choose which method is used for your pouchoscopy, giving an equal chance to both techniques.

Will taking part mean extra appointments?

No, your participation happens during your regular, scheduled pouchoscopy appointment. There are no extra visits or follow-ups specifically for this study beyond your routine care.

How to find out more

Andrew Latchford, MBBS PhD FRCP

andrew.latchford@nhs.net +442088643232 Official trial record

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