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

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.

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 Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis; Ileostomy - Stoma
• Intervention / Treatment: Procedure: Ileal pouch anal anastomosis (IPAA); Procedure: Ileorectal anastomosis (IRA); Procedure: ileostomy

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anton Risto; Phone Number: 0702510374; Email: anton.risto@liu.se
• Study Contact Backup: Name: Pär Myrelid, Prof.; Phone Number: +46 0 10 1031581; Email: par.myrelid@liu.se

Study Locations

• Sweden
  • Gothenburg, Sweden, SE-413 45
    • Recruiting
    • Sahlgrenska Univercity Hospital
    • Contact: Maria Hermansson; Phone Number: +46 0 76 0401039
  • Linköping, Sweden, 58731
    • Recruiting
    • Linkoeping University Hospital
    • Contact: Anton Risto; Phone Number: 0702510374; Email: anton.risto@liu.se
    • Contact: Pär Myrelid
  • Solna, Sweden, SE-171 76
    • Recruiting
    • Karolinska University Hospital
    • Contact: Caroline Nordenvall; Phone Number: +46 0 70 6579109
• United Kingdom
  • London, United Kingdom, HA1 3UJ
    • Recruiting
    • St. Mark's Hospital
    • Contact: Mohammed Deputy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	yes/no question if the patient is satisfied with his/her choice of operation	2months
Patient satisfaction	yes/no question if the patient is satisfied with his/her choice of operation	1year
Patient satisfaction	yes/no question if the patient is satisfied with his/her choice of operation	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Öresland Score	Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.	2 months
Öresland Score	Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.	6 months
Öresland Score	Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.	1 year
Öresland Score	Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.	2 years
Öresland Score	Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.	5 years
failure	Extirpation of reconstruction or permanant stoma deviation	2 months
failure	Extirpation of reconstruction or permanant stoma deviation	6 months
failure	Extirpation of reconstruction or permanant stoma deviation	1 year
failure	Extirpation of reconstruction or permanant stoma deviation	2 years
failure	Extirpation of reconstruction or permanant stoma deviation	5 years
reoperations	number of reoperations	2 months
reoperations	number of reoperations	6 months
reoperations	number of reoperations	1 year
reoperations	number of reoperations	2 years
reoperations	number of reoperations	5 years

Collaborators and Investigators

• Sponsor: Linkoeping University
• Collaborators: Karolinska University Hospital; University College London Hospitals; Göteborg University
• Investigators: Study Chair: Caroline Nordenvall, Ass. Prof, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2029

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Reconstruction; Colectomy; Ulcerative Colitis,
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Ulcer; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 2017/124-31/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No