RecruitingNot ApplicableNCT05628701

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

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.

Sponsor

Linkoeping University

Enrollment

100 participants

Start Date

Apr 4, 2017

Study Type

INTERVENTIONAL

Conditions

Inflammatory Bowel Diseases Ulcerative Colitis Ileostomy - Stoma

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different surgical reconstruction options for people with ulcerative colitis (a chronic inflammatory bowel disease) who have had their large intestine removed. The two options are: connecting the small intestine directly to the rectum (ileorectal anastomosis) versus creating an internal pouch connected to the anus (ileal pouch-anal anastomosis). Both aim to restore bowel function without a permanent stoma bag. **You may be eligible if...** - You have ulcerative colitis and are between 18 and 60 years old - You have already had your colon surgically removed (subtotal colectomy) and currently have a temporary ileostomy - Your rectal inflammation is mild (Mayo Score ≤1) and controllable with topical mesalazine only - Your rectal sphincter (anal muscle) is functioning normally **You may NOT be eligible if...** - You have active rectal inflammation (Mayo Score above 1) - You have poor sphincter function or perianal disease (fistulas, abscesses) - The diagnosis of ulcerative colitis is uncertain - You have had colorectal cancer or severe pre-cancerous changes - You have primary sclerosing cholangitis (a liver bile duct disease) - It has been more than 2 years since your colectomy Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIleorectal 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))

PROCEDUREIleal 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)).

PROCEDUREileostomy

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