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

Sponsor

Linkoeping University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05628701

Collaborator

Karolinska University Hospital (Other), Göteborg University (Other), University College London Hospitals (Other)

100

Enrollment

Locations

Arms

152.9

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis Inflammatory Bowel Diseases Ileostomy - Stoma	Procedure: Ileorectal anastomosis (IRA) Procedure: Ileal pouch anal anastomosis (IPAA) Procedure: ileostomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

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 colectomyThe 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

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Apr 4, 2017

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IPAA CRUISE Patients eligible for both operations choosing ileal pouch anal anastomosis.	Procedure: Ileal 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)).
Experimental: IRA CRUISE Patients eligible for both operations choosing ileorectal anastomosis.	Procedure: Ileorectal 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))
Active Comparator: IRA Control Patients only eligible for ileorectal anastomosis.	Procedure: Ileorectal 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))
Active Comparator: IPAA Control Patients only eligible for ileal pouch anal anastomosis.	Procedure: Ileal 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)).
Active Comparator: Ileostomy Control Patients who decline reconstruction.	Procedure: ileostomy no reconstruction is performed and the patient is left with his/her ileostomy

Outcome Measures

Primary Outcome Measures

Patient satisfaction [2months]
yes/no question if the patient is satisfied with his/her choice of operation
Patient satisfaction [1year]
yes/no question if the patient is satisfied with his/her choice of operation
Patient satisfaction [5 years]
yes/no question if the patient is satisfied with his/her choice of operation

Secondary Outcome Measures

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
SF-36(short form-36 item) [6 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
SF-36(short form-36 item) [1 year]
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
SF-36(short form-36 item) [2 years]
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
SF-36(short form-36 item) [5 years]
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
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.
Female Sexual Function Index-6 (FSFI-6) [6months]
6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.
Female Sexual Function Index-6 (FSFI-6) [1 year]
6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.
Female Sexual Function Index-6 (FSFI-6) [2 years]
6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.
Female Sexual Function Index-6 (FSFI-6) [5 years]
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.
International Index of Erectile Function-5 (IIEF-5) [6 months]
5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.
International Index of Erectile Function-5 (IIEF-5) [1 year]
5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.
International Index of Erectile Function-5 (IIEF-5) [2 years]
5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.
International Index of Erectile Function-5 (IIEF-5) [5 years]
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.
Shor health scale (SHS) [6 months]
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Shor health scale (SHS) [1 year]
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Shor health scale (SHS) [2 years]
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Shor health scale (SHS) [5 years]
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Öresland Score [2 months]
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Öresland Score [6 months]
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Öresland Score [1 year]
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Öresland Score [2 years]
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Öresland Score [5 years]
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
failure [2 months]
Extirpation of reconstruction or permanant stoma deviation
failure [6 months]
Extirpation of reconstruction or permanant stoma deviation
failure [1 year]
Extirpation of reconstruction or permanant stoma deviation
failure [2 years]
Extirpation of reconstruction or permanant stoma deviation
failure [5 years]
Extirpation of reconstruction or permanant stoma deviation
reoperations [2 months]
number of reoperations
reoperations [6 months]
number of reoperations
reoperations [1 year]
number of reoperations
reoperations [2 years]
number of reoperations
reoperations [5 years]
number of reoperations

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Sahlgrenska Univercity Hospital	Gothenburg	Sweden	SE-413 45
2	Linkoeping University hospital	Linköping	Sweden	58731
3	Karolinska University Hospital	Solna	Sweden	se-171 76
4	St. Mark's Hospital	London	United Kingdom	HA1 3UJ