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.
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.
Rectal inflammation of Mayo Score >1
Poor sphincter function, perianal disease
Uncertainty regarding UC diagnosis P
Previous colorectal cancer or severe dysplasia
Parallel
Ileorectal anastomosis (IRA)
Procedure/SurgeryAfter 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))
Ileal pouch anal anastomosis (IPAA)
Procedure/SurgeryThe 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)).
ileostomy
Procedure/Surgeryno reconstruction is performed and the patient is left with his/her ileostomy
Patient satisfaction
yes/no question if the patient is satisfied with his/her choice of operation
Patient satisfaction
yes/no question if the patient is satisfied with his/her choice of operation
Patient satisfaction
yes/no question if the patient is satisfied with his/her choice of operation
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
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
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
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
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Linkoeping University
Lead sponsor
Karolinska University Hospital
Collaborator
Göteborg University
Collaborator
University College London Hospitals
Collaborator
