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

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.

Conditions

• Ulcerative Colitis
• Inflammatory Bowel Diseases
• Ileostomy - Stoma

Interventions

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))

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)).

PROCEDURE

ileostomy

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

Sponsors & Collaborators

• Karolinska University Hospital

  collaborator OTHER

• Göteborg University

  collaborator OTHER

• University College London Hospitals

  collaborator OTHER

• Linkoeping University

  lead OTHER_GOV

Principal Investigators

• Caroline Nordenvall, Ass. Prof · Karolinska Institutet

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-04

Primary Completion

2024-12-31

Completion

2029-12-31

Countries

• Sweden
• United Kingdom

Study Locations