Ileostomy - Stoma, Inflammatory Bowel Diseases, Ulcerative Colitis
Conditions
Keywords
Ulcerative Colitis,, Colectomy, Reconstruction
Brief summary
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.
Interventions
PROCEDUREIleorectal anastomosis (IRA)
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))
PROCEDUREIleal pouch anal anastomosis (IPAA)
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)).
PROCEDUREileostomy
no reconstruction is performed and the patient is left with his/her ileostomy
Sponsors
Karolinska University Hospital
Göteborg University
University College London Hospitals
Linkoeping University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The CRUISE study is a prospective, non-randomized, non-blinded, multi-center, controlled trial on satisfaction, QoL, function, and complications between IRA and IPAA and permanent stoma among adult UC patients subjected to subtotal colectomy
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 2months | yes/no question if the patient is satisfied with his/her choice of operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Female Sexual Function Index-6 (FSFI-6) | 2months | 6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning. |
| International Index of Erectile Function-5 (IIEF-5) | 2 months | 5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning. |
| Shor health scale (SHS) | 2 months | IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life. |
| SF-36(short form-36 item) | 2 months | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability |
| failure | 2 months | Extirpation of reconstruction or permanant stoma deviation |
| reoperations | 2 months | number of reoperations |
| Öresland Score | 2 months | Bowel function score rangeing from 0-17 with higher scores indicating worse functioning. |
Countries
Sweden, United Kingdom
Contacts
Primary ContactAnton Risto
Backup ContactPär Myrelid, Prof.
Outcome results
None listed