RecruitingNAINTERVENTIONAL

Colectomy Reconstruction for Ulcerative Colitis, Ileorectal Anastomosis vs Ileal Pouch-Anal Anastomosis in Ulcerative Colitis.

If you have Ulcerative Colitis and have had surgery to remove most of your large bowel, you might be considering ways to reconnect your gut. This study, called CRUISE, is looking at two main surgical options for this: an ileorectal anastomosis (IRA) and an ileal pouch-anal anastomosis (IPAA). The aim is to understand which of these surgeries leads to better satisfaction, life quality, and fewer issues for patients in the UK. Because people often want to choose their own surgery, this study lets patients decide which option they prefer after learning about both. It will then track their progress, including how happy they are with the results and any complications, to help guide future decisions about these important operations.

At a glance

Status

Recruiting

Phase

Sponsor

Linkoeping University

Enrolment target

100

Start

04 Apr 2017

Estimated completion

31 Dec 2029

Ulcerative Colitis Inflammatory Bowel Diseases Ileostomy - Stoma

What is this study about?

When someone with Ulcerative Colitis has surgery to remove their large bowel (a procedure called a colectomy), doctors often try to reconnect the digestive system. This avoids needing a permanent bag on the outside of the body for waste, which is called an ileostomy. There are two main ways to do this: one is called an ileal pouch-anal anastomosis (often shortened to IPAA) and the other is an ileorectal anastomosis (IRA).

Up until now, doctors haven't had clear comparisons from studies about which of these two main reconstruction options is best for patients. This means it can be hard to advise patients on which choice might give them the best quality of life, satisfaction, and fewest problems. This CRUISE study aims to fill that gap.

The CRUISE study is important because these surgeries are a big deal for patients, affecting their daily lives. By carefully looking at the experiences of people who choose either the IPAA or IRA, the study hopes to provide clear, reliable information. This will help both patients and doctors make more informed decisions about which reconstructive surgery might be the best fit for an individual.

Key takeaways

This study compares two surgeries to reconnect your gut after Ulcerative Colitis surgery.
It aims to find out which surgery leads to better quality of life and fewer problems.
Patients get to choose their preferred surgery after learning about both options.
The study tracks patient satisfaction, bowel function, and any complications.
It will help future patients and doctors make informed decisions about these operations.

Who may be eligible?

This study is for adults with Ulcerative Colitis, between 18 and 60 years old. You should either be planning to have surgery to remove most of your large bowel (colectomy) and have an ileostomy, or have already had this surgery. To be considered, your rectum (the last part of your large bowel) needs to be able to stretch well and any inflammation in it should be controlled using only mild, topical medication like Mesalazine.

There are some reasons why you wouldn't be able to join the study. For example, if the inflammation in your rectum is too severe, or if you have poor control over your bowel movements (weak sphincter muscles), or other bowel problems around the back passage. You also can't join if there are any doubts about your Ulcerative Colitis diagnosis, if you've had bowel cancer or severe abnormal cells, or if you have a condition called Primary Sclerosing Cholangitis.

Finally, if it's been more than two years since you had your large bowel partially removed, you wouldn't be able to join this particular study.

Quick self-check

Are you between 18 and 60 years old?
Do you have Ulcerative Colitis?
Are you having a colectomy and ileostomy, or have you already had one?
Is any inflammation in your rectum controlled with mild medication only?
Do you have good control over your bowel movements (good sphincter function)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the CRUISE study, you'll first receive clear information about both reconstructive surgery options. You'll then be able to choose the surgery you prefer. After your surgery, the research team will follow your progress over time. This will involve regular check-ups and assessments to understand your satisfaction with the surgery, your quality of life, how well your bowel is functioning, and if you experience any complications. The exact number of visits and the total duration aren't fully detailed here, but these kinds of studies typically involve follow-ups for several years to get a good long-term picture.

Potential risks and benefits

Like any medical procedure, there are potential benefits and risks to reconstructive surgery. The main benefit hoped for from these surgeries is an improvement in your quality of life and the ability to avoid a permanent ileostomy bag. However, no surgery is without risks, and complications can include infection, leaks, or issues with bowel function. This study aims to understand these risks better for each type of surgery. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Sahlgrenska Univercity Hospital
Gothenburg, Sweden· Recruiting
Linkoeping University hospital
Linköping, Sweden· Recruiting
Karolinska University Hospital
Solna, Sweden· Recruiting
St. Mark's Hospital
London, United Kingdom· Recruiting

Common questions

What is Ulcerative Colitis?

Ulcerative Colitis is a long-term condition where the large bowel (colon) and rectum become inflamed and develop small ulcers.

What is an ileostomy?

An ileostomy is a surgical opening that brings a part of the small bowel (ileum) to the outside of the body, allowing waste to be collected in a bag.

What is an ileal pouch?

An ileal pouch (IPAA) is a new 'pouch' created from a part of your small bowel to store waste before it leaves your body naturally, avoiding an external bag.

What is an ileorectal anastomosis?

This surgery (IRA) connects your small bowel directly to your rectum after the rest of your large bowel has been removed.

Why is this study letting patients choose their surgery?

Previous attempts showed that patients strongly preferred to choose their own surgery, so this study is designed to respect that choice while still gathering valuable information.

How to find out more

Anton Risto

anton.risto@liu.se 0702510374 Official trial record

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