Clinical trial NCT05628701: Colectomy Reconstruction for Ulcerative Colitis, Ileorectal Anastomosis vs Ileal Pouch-Anal Anastomosis in Ulcerative Colitis.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ulcerative Colitis
Inflammatory Bowel Diseases
Ileostomy - Stoma
Keywords: Ulcerative Colitis,
Colectomy
Reconstruction
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska University Hospital
name: Göteborg University
name: University College London Hospitals
First posted: 2022-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The CRUISE study is a prospective, non-randomized, non-blinded, multi-center, controlled trial on satisfaction, QoL, function, and complications between IRA and IPAA and permanent stoma among adult UC patients subjected to subtotal colectomy
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Patient satisfaction
timeFrame: 2months
measure: Patient satisfaction
timeFrame: 1year
measure: Patient satisfaction
timeFrame: 5 years
Secondary outcomes:
measure: SF-36(short form-36 item)
timeFrame: 2 months
measure: SF-36(short form-36 item)
timeFrame: 6 months
measure: SF-36(short form-36 item)
timeFrame: 1 year
measure: SF-36(short form-36 item)
timeFrame: 2 years
measure: SF-36(short form-36 item)
timeFrame: 5 years
measure: Female Sexual Function Index-6 (FSFI-6)
timeFrame: 2months
measure: Female Sexual Function Index-6 (FSFI-6)
timeFrame: 6months
measure: Female Sexual Function Index-6 (FSFI-6)
timeFrame: 1 year
measure: Female Sexual Function Index-6 (FSFI-6)
timeFrame: 2 years
measure: Female Sexual Function Index-6 (FSFI-6)
timeFrame: 5 years
measure: International Index of Erectile Function-5 (IIEF-5)
timeFrame: 2 months
measure: International Index of Erectile Function-5 (IIEF-5)
timeFrame: 6 months
measure: International Index of Erectile Function-5 (IIEF-5)
timeFrame: 1 year
measure: International Index of Erectile Function-5 (IIEF-5)
timeFrame: 2 years
measure: International Index of Erectile Function-5 (IIEF-5)
timeFrame: 5 years
measure: Shor health scale (SHS)
timeFrame: 2 months
measure: Shor health scale (SHS)
timeFrame: 6 months
measure: Shor health scale (SHS)
timeFrame: 1 year
measure: Shor health scale (SHS)
timeFrame: 2 years
measure: Shor health scale (SHS)
timeFrame: 5 years
measure: Öresland Score
timeFrame: 2 months
measure: Öresland Score
timeFrame: 6 months
measure: Öresland Score
timeFrame: 1 year
measure: Öresland Score
timeFrame: 2 years
measure: Öresland Score
timeFrame: 5 years
measure: failure
timeFrame: 2 months
measure: failure
timeFrame: 6 months
measure: failure
timeFrame: 1 year
measure: failure
timeFrame: 2 years
measure: failure
timeFrame: 5 years
measure: reoperations
timeFrame: 2 months
measure: reoperations
timeFrame: 6 months
measure: reoperations
timeFrame: 1 year
measure: reoperations
timeFrame: 2 years
measure: reoperations
timeFrame: 5 years
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska Univercity Hospital
city: Linköping
country: Sweden
facility: Linkoeping University hospital
city: Solna
country: Sweden
facility: Karolinska University Hospital
city: London
country: United Kingdom
facility: St. Mark's Hospital
Study officials:
affiliation: Karolinska Institutet
name: Caroline Nordenvall, Ass. Prof
role: STUDY_CHAIR
References: