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

Ulcerative Colitis Clinical Trial

— CRUISE  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05628701
• Other study ID #: 2017/124-31/2
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2017
• Est. completion date: December 31, 2029

Study information

• Verified date: November 2022
• Source: Linkoeping University
• Contact: Anton Risto
• Phone: 0702510374
• Email: anton.risto[@]liu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ileostomy - Stoma
• Inflammatory Bowel Diseases
• Ulcer
• Ulcerative Colitis

Intervention

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))
• 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)).
• ileostomy
no reconstruction is performed and the patient is left with his/her ileostomy

Locations

Country	Name	City	State
Sweden	Sahlgrenska Univercity Hospital	Gothenburg
Sweden	Linkoeping University hospital	Linköping
Sweden	Karolinska University Hospital	Solna
United Kingdom	St. Mark's Hospital	London

Sponsors (4)

Lead Sponsor	Collaborator
Linkoeping University	Göteborg University, Karolinska University Hospital, University College London Hospitals

Countries where clinical trial is conducted

Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction	yes/no question if the patient is satisfied with his/her choice of operation	2months
Primary	Patient satisfaction	yes/no question if the patient is satisfied with his/her choice of operation	1year
Primary	Patient satisfaction	yes/no question if the patient is satisfied with his/her choice of operation	5 years
Secondary	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	2 months
Secondary	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	6 months
Secondary	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	1 year
Secondary	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	2 years
Secondary	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	5 years
Secondary	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.	2months
Secondary	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.	6months
Secondary	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.	1 year
Secondary	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.	2 years
Secondary	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.	5 years
Secondary	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.	2 months
Secondary	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.	6 months
Secondary	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.	1 year
Secondary	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.	2 years
Secondary	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.	5 years
Secondary	Shor health scale (SHS)	IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.	2 months
Secondary	Shor health scale (SHS)	IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.	6 months
Secondary	Shor health scale (SHS)	IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.	1 year
Secondary	Shor health scale (SHS)	IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.	2 years
Secondary	Shor health scale (SHS)	IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.	5 years
Secondary	Öresland Score	Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.	2 months
Secondary	Öresland Score	Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.	6 months
Secondary	Öresland Score	Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.	1 year
Secondary	Öresland Score	Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.	2 years
Secondary	Öresland Score	Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.	5 years
Secondary	failure	Extirpation of reconstruction or permanant stoma deviation	2 months
Secondary	failure	Extirpation of reconstruction or permanant stoma deviation	6 months
Secondary	failure	Extirpation of reconstruction or permanant stoma deviation	1 year
Secondary	failure	Extirpation of reconstruction or permanant stoma deviation	2 years
Secondary	failure	Extirpation of reconstruction or permanant stoma deviation	5 years
Secondary	reoperations	number of reoperations	2 months
Secondary	reoperations	number of reoperations	6 months
Secondary	reoperations	number of reoperations	1 year
Secondary	reoperations	number of reoperations	2 years
Secondary	reoperations	number of reoperations	5 years