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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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))
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)).
no reconstruction is performed and the patient is left with his/her ileostomy
Sahlgrenska Univercity Hospital
Gothenburg, Sweden
RECRUITINGLinkoeping University hospital
Linköping, Sweden
RECRUITINGKarolinska University Hospital
Solna, Sweden
RECRUITINGSt. Mark's Hospital
London, United Kingdom
RECRUITINGPatient satisfaction
yes/no question if the patient is satisfied with his/her choice of operation
Time frame: 2months
Patient satisfaction
yes/no question if the patient is satisfied with his/her choice of operation
Time frame: 1year
Patient satisfaction
yes/no question if the patient is satisfied with his/her choice of operation
Time frame: 5 years
SF-36(short form-36 item)
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
Time frame: 2 months
SF-36(short form-36 item)
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
Time frame: 6 months
SF-36(short form-36 item)
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
Time frame: 1 year
SF-36(short form-36 item)
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
Time frame: 2 years
SF-36(short form-36 item)
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
Time frame: 5 years
Female Sexual Function Index-6 (FSFI-6)
6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.
Time frame: 2months
Female Sexual Function Index-6 (FSFI-6)
6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.
Time frame: 6months
Female Sexual Function Index-6 (FSFI-6)
6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.
Time frame: 1 year
Female Sexual Function Index-6 (FSFI-6)
6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.
Time frame: 2 years
Female Sexual Function Index-6 (FSFI-6)
6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.
Time frame: 5 years
International Index of Erectile Function-5 (IIEF-5)
5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.
Time frame: 2 months
International Index of Erectile Function-5 (IIEF-5)
5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.
Time frame: 6 months
International Index of Erectile Function-5 (IIEF-5)
5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.
Time frame: 1 year
International Index of Erectile Function-5 (IIEF-5)
5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.
Time frame: 2 years
International Index of Erectile Function-5 (IIEF-5)
5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.
Time frame: 5 years
Shor health scale (SHS)
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Time frame: 2 months
Shor health scale (SHS)
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Time frame: 6 months
Shor health scale (SHS)
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Time frame: 1 year
Shor health scale (SHS)
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Time frame: 2 years
Shor health scale (SHS)
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Time frame: 5 years
Öresland Score
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Time frame: 2 months
Öresland Score
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Time frame: 6 months
Öresland Score
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Time frame: 1 year
Öresland Score
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Time frame: 2 years
Öresland Score
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Time frame: 5 years
failure
Extirpation of reconstruction or permanant stoma deviation
Time frame: 2 months
failure
Extirpation of reconstruction or permanant stoma deviation
Time frame: 6 months
failure
Extirpation of reconstruction or permanant stoma deviation
Time frame: 1 year
failure
Extirpation of reconstruction or permanant stoma deviation
Time frame: 2 years
failure
Extirpation of reconstruction or permanant stoma deviation
Time frame: 5 years
reoperations
number of reoperations
Time frame: 2 months
reoperations
number of reoperations
Time frame: 6 months
reoperations
number of reoperations
Time frame: 1 year
reoperations
number of reoperations
Time frame: 2 years
reoperations
number of reoperations
Time frame: 5 years
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