At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Ileorectal anastomosis (IRA) (procedure), Ileal pouch anal anastomosis (IPAA) (procedure), ileostomy (procedure)
- How long the study runs
- Study runs about 152 months (dates as stated)
- About the drug or intervention
- Ileorectal anastomosis (IRA) — procedure: After subtotal colectomy for ulcerative colitis the patients can either keep their end ileostomy or be reconstructed with an anastomosis (connection) between the ileum and the rectal remnant (Ileorectal anastomosis(IRA)) · Ileal pouch anal anastomosis (IPAA) — procedure: The rectum is removed and a pouch constructed with the distal part opf the ileum which in subsequently anastomosed (connected) to the anus(Ileal pouch anal anastomosis (IPAA)). · ileostomy — procedure: no reconstruction is performed and the patient is left with his/her ileostomy
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Linköping University, looks at two different ways of rebuilding the bowel after surgery for ulcerative colitis (a long-term condition causing inflammation in the bowel). It compares joining the small bowel to the rectum with making an internal pouch. Not stated — ask the trial team for more details on what the study involves.
Who can take part
- Adults aged 18 to 60 with ulcerative colitis
- People who are due to have, or have already had, surgery to remove most of the large bowel with a stoma (an opening on the tummy for waste)
- The rectum must be flexible enough and any inflammation there must be controlled using a topical medicine called Mesalazine alone
Who may not be able to
- Inflammation in the rectum scoring above 1 on the Mayo scale
- Weak bowel control (sphincter) muscles or disease around the back passage
- Any doubt about whether the diagnosis is ulcerative colitis
- Past bowel cancer or severe pre-cancerous changes
- A diagnosis of primary sclerosing cholangitis
- More than 2 years since the surgery to remove most of the large bowel
What taking part involves
- • Comparing two types of reconstruction surgery: joining the small bowel directly to the rectum, or creating an internal pouch connected to the anal canal
- • Not stated — ask the trial team about any other tests or procedures involved
Time commitment: Not stated — ask the trial team about how many visits, how long the study lasts, and what taking part would involve.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 60 Years
- Who
- All
- Number of participants
- 100
- Started
- 2017-04-04
- Last checked
- 2022-11
Plain English Summary
What is this study?
- • Testing a new treatment for ulcerative colitis
- • NA - 100 participants
- • Background There are no prospective trials comparing the two main reconstructive options after colectomy for Ulcerative colitis, ileal pouch anal anastomosis and ileorectal anastomosis
Who can take part?
- • Ages 18 Years to 60 Years
- • Diagnosed with ulcerative colitis
Where?
- • London - St. Mark's Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Background There are no prospective trials comparing the two main reconstructive options after colectomy for Ulcerative colitis, ileal pouch anal anastomosis and ileorectal anastomosis. An attempt on a randomized controlled trial has been made but after receiving standardized information patients insisted on choosing operation themselves. Methods Adult Ulcerative colitis patients subjected to colectomy eligible for both ileal pouch anastomosis and ileorectal anastomosis are asked to participate and after receiving standardized information the get to choose reconstructive method. Patients not declining reconstruction or not considered eligible for both methods will be followed as controls. The CRUISE study is a prospective, non-randomized, multi-center, controlled trial on satisfaction, QoL, function, and complications between ileal pouch anal anastomosis and ileorectal anastomosis. Discussion Reconstruction after colectomy is a morbidity-associated as well as a resource-intensive activity with the sole purpose of enhancing function, Quality of Life and patient satisfaction. The aim of this study is to provide the best possible information on the risks and benefits of each reconstructive treatment.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 60 Years
- Who can join: All genders
What the study is looking for
- ✓Patients with Ulcerative colitis (UC) aged between 18 and 60
- ✓Scheduled for or have previously undergone subtotal colectomy and ileostomy.
- ✓Patients should have sufficient rectal compliance and controllable inflammation in the rectal using topical...
- ✓Exclusion criteria
- ✓Rectal inflammation of Mayo Score \>1
See the full criteria
Where Is This Study? (1 UK site)
St. Mark's Hospital
London HA1 3UJ, United Kingdom
How to Get in Touch
Anton Risto
Sponsor contactCONTACT
Pär Myrelid, Prof.
Sponsor contactCONTACT