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

Linköping University (LiU)

Status: Enrolling

Conditions: Ileostomy - Stoma; Ulcerative Colitis; Inflammatory Bowel Diseases

Treatments: Procedure: Ileorectal anastomosis (IRA); Procedure: ileostomy; Procedure: Ileal pouch anal anastomosis (IPAA)

Study type: Interventional

Funder types: Other

Identifiers

NCT05628701

2017/124-31/2

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 5 patient groups

IPAA CRUISE

Experimental group

Description:

Patients eligible for both operations choosing ileal pouch anal anastomosis.

Treatment:

Procedure: Ileal pouch anal anastomosis (IPAA)

IRA CRUISE

Experimental group

Description:

Patients eligible for both operations choosing ileorectal anastomosis.

Treatment:

Procedure: Ileorectal anastomosis (IRA)

IRA Control

Active Comparator group

Description:

Patients only eligible for ileorectal anastomosis.

Treatment:

Procedure: Ileorectal anastomosis (IRA)

IPAA Control

Active Comparator group

Description:

Patients only eligible for ileal pouch anal anastomosis.

Treatment:

Procedure: Ileal pouch anal anastomosis (IPAA)

Ileostomy Control

Active Comparator group

Description:

Patients who decline reconstruction.

Treatment:

Procedure: ileostomy