Colectomy Reconstruction for Ulcerative Colitis, Ileorectal Anastomosis vs Ileal Pouch-Anal Anastomosis in Ulcerative Colitis.
Not applicable · Testing Ileorectal anastomosis (IRA), Ileal pouch anal anastomosis (IPAA) and ileostomy · 4 sites · Linkoeping University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Ileorectal anastomosis (IRA) (a procedure), Ileal pouch anal anastomosis (IPAA) (a procedure) and ileostomy (a procedure) as a possible treatment. Condition(s) listed: Ulcerative Colitis, Inflammatory Bowel Diseases and Ileostomy - Stoma.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 60
- Any sex
Some of the main requirements, copied from the record:
- 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 Mezalasin only.
There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 100 participants are expected to take part.
- Start date: 2017-04-04.
- Main results expected around 2024-12-31 (estimate from the record).
- 4 study sites listed (4 marked recruiting) in Sweden and United Kingdom.
Main thing being measured
- Patient satisfaction (2months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis; Inflammatory Bowel Diseases; Ileostomy - Stoma |
| Lead sponsor | Linkoeping University |
| Collaborators | Karolinska University Hospital; Göteborg University; University College London Hospitals |
| Enrollment | 100 (estimated) |
| Start date | 2017-04-04 |
| Primary completion (est.) | 2024-12-31 |
| First posted | 2022-11-29 |
| Last updated | 2022-11-29 |
| Official title | Colectomy Reconstruction for Ulcerative Colitis In Sweden and England: a Multicenter Prospective Comparison Between Ileorectal Anastomosis and Ileal Pouch-Anal Anastomosis After Colectomy in Patients With Ulcerative Colitis. |
| ClinicalTrials.gov ID | NCT05628701 |
Interventions
- 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
Full eligibility criteria (from the record)
Inclusion criteria: * 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 Mezalasin only. Exclusion criteria * Rectal inflammation of Mayo Score >1 * Poor sphincter function, perianal disease * Uncertainty regarding UC diagnosis P * Previous colorectal cancer or severe dysplasia * Primary Sclerosing Colitis diagnosis * >2 year since subtotal colectomy
Locations (4)
| Site | City | Country | Site status |
|---|---|---|---|
| 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 |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.