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

Not Applicable

Recruiting

• Conditions: Ileostomy - Stoma; Ulcerative Colitis; Inflammatory Bowel Diseases
• Interventions: Procedure: Ileorectal anastomosis (IRA); Procedure: Ileal pouch anal anastomosis (IPAA); Procedure: ileostomy

• Registration Number: NCT05628701
• Lead Sponsor: Linkoeping University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-04
• Study First Submitted: 2022-10-28
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-16
• Last Update Submitted: 2022-11-16
• Study First Posted: 2022-11-29
• Last Update Posted: 2022-11-29
• Primary Completion: 2024-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IRA CRUISE	Ileorectal anastomosis (IRA)	Patients eligible for both operations choosing ileorectal anastomosis.
IPAA CRUISE	Ileal pouch anal anastomosis (IPAA)	Patients eligible for both operations choosing ileal pouch anal anastomosis.
Ileostomy Control	ileostomy	Patients who decline reconstruction.
IRA Control	Ileorectal anastomosis (IRA)	Patients only eligible for ileorectal anastomosis.
IPAA Control	Ileal pouch anal anastomosis (IPAA)	Patients only eligible for ileal pouch anal anastomosis.

Primary Outcome Measures

Name	Time	Method
Patient satisfaction	5 years	yes/no question if the patient is satisfied with his/her choice of operation

Secondary Outcome Measures

Name	Time	Method
failure	5 years	Extirpation of reconstruction or permanant stoma deviation
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)	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)	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)	5 years	IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Öresland Score	5 years	Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
reoperations	5 years	number of reoperations

Trial Locations

Locations (4)

Sahlgrenska Univercity Hospital; 🇸🇪 Gothenburg, Sweden

Linkoeping University hospital; 🇸🇪 Linköping, Sweden

Karolinska University Hospital; 🇸🇪 Solna, Sweden

St. Mark's Hospital; 🇬🇧 London, United Kingdom