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

Primary Purpose

Ulcerative Colitis, Inflammatory Bowel Diseases, Ileostomy - Stoma

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ileorectal anastomosis (IRA)
Ileal pouch anal anastomosis (IPAA)
ileostomy
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis,, Colectomy, Reconstruction

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sahlgrenska Univercity HospitalRecruiting
  • Linkoeping University hospitalRecruiting
  • Karolinska University HospitalRecruiting
  • St. Mark's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

IPAA CRUISE

IRA CRUISE

IRA Control

IPAA Control

Ileostomy Control

Arm Description

Patients eligible for both operations choosing ileal pouch anal anastomosis.

Patients eligible for both operations choosing ileorectal anastomosis.

Patients only eligible for ileorectal anastomosis.

Patients only eligible for ileal pouch anal anastomosis.

Patients who decline reconstruction.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Female Sexual Function Index-6 (FSFI-6)
6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.
Female Sexual Function Index-6 (FSFI-6)
6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.
Female Sexual Function Index-6 (FSFI-6)
6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.
Female Sexual Function Index-6 (FSFI-6)
6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.
Female Sexual Function Index-6 (FSFI-6)
6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.
International Index of Erectile Function-5 (IIEF-5)
5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.
International Index of Erectile Function-5 (IIEF-5)
5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.
International Index of Erectile Function-5 (IIEF-5)
5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.
International Index of Erectile Function-5 (IIEF-5)
5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.
International Index of Erectile Function-5 (IIEF-5)
5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.
Shor health scale (SHS)
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Shor health scale (SHS)
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Shor health scale (SHS)
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Shor health scale (SHS)
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Shor health scale (SHS)
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Öresland Score
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Öresland Score
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Öresland Score
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Öresland Score
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Öresland Score
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
failure
Extirpation of reconstruction or permanant stoma deviation
failure
Extirpation of reconstruction or permanant stoma deviation
failure
Extirpation of reconstruction or permanant stoma deviation
failure
Extirpation of reconstruction or permanant stoma deviation
failure
Extirpation of reconstruction or permanant stoma deviation
reoperations
number of reoperations
reoperations
number of reoperations
reoperations
number of reoperations
reoperations
number of reoperations
reoperations
number of reoperations

Full Information

First Posted
October 28, 2022
Last Updated
November 16, 2022
Sponsor
Linkoeping University
Collaborators
Karolinska University Hospital, Göteborg University, University College London Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT05628701
Brief Title
Colectomy Reconstruction for Ulcerative Colitis, Ileorectal Anastomosis vs Ileal Pouch-Anal Anastomosis in Ulcerative Colitis.
Acronym
CRUISE
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
Collaborators
Karolinska University Hospital, Göteborg University, University College London Hospitals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Inflammatory Bowel Diseases, Ileostomy - Stoma
Keywords
Ulcerative Colitis,, Colectomy, Reconstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IPAA CRUISE
Arm Type
Experimental
Arm Description
Patients eligible for both operations choosing ileal pouch anal anastomosis.
Arm Title
IRA CRUISE
Arm Type
Experimental
Arm Description
Patients eligible for both operations choosing ileorectal anastomosis.
Arm Title
IRA Control
Arm Type
Active Comparator
Arm Description
Patients only eligible for ileorectal anastomosis.
Arm Title
IPAA Control
Arm Type
Active Comparator
Arm Description
Patients only eligible for ileal pouch anal anastomosis.
Arm Title
Ileostomy Control
Arm Type
Active Comparator
Arm Description
Patients who decline reconstruction.
Intervention Type
Procedure
Intervention Name(s)
Ileorectal anastomosis (IRA)
Intervention Description
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))
Intervention Type
Procedure
Intervention Name(s)
Ileal pouch anal anastomosis (IPAA)
Intervention Description
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)).
Intervention Type
Procedure
Intervention Name(s)
ileostomy
Intervention Description
no reconstruction is performed and the patient is left with his/her ileostomy
Primary Outcome Measure Information:
Title
Patient satisfaction
Description
yes/no question if the patient is satisfied with his/her choice of operation
Time Frame
2months
Title
Patient satisfaction
Description
yes/no question if the patient is satisfied with his/her choice of operation
Time Frame
1year
Title
Patient satisfaction
Description
yes/no question if the patient is satisfied with his/her choice of operation
Time Frame
5 years
Secondary Outcome Measure Information:
Title
SF-36(short form-36 item)
Description
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
Time Frame
2 months
Title
SF-36(short form-36 item)
Description
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
Time Frame
6 months
Title
SF-36(short form-36 item)
Description
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
Time Frame
1 year
Title
SF-36(short form-36 item)
Description
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
Time Frame
2 years
Title
SF-36(short form-36 item)
Description
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
Time Frame
5 years
Title
Female Sexual Function Index-6 (FSFI-6)
Description
6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.
Time Frame
2months
Title
Female Sexual Function Index-6 (FSFI-6)
Description
6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.
Time Frame
6months
Title
Female Sexual Function Index-6 (FSFI-6)
Description
6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.
Time Frame
1 year
Title
Female Sexual Function Index-6 (FSFI-6)
Description
6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.
Time Frame
2 years
Title
Female Sexual Function Index-6 (FSFI-6)
Description
6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.
Time Frame
5 years
Title
International Index of Erectile Function-5 (IIEF-5)
Description
5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.
Time Frame
2 months
Title
International Index of Erectile Function-5 (IIEF-5)
Description
5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.
Time Frame
6 months
Title
International Index of Erectile Function-5 (IIEF-5)
Description
5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.
Time Frame
1 year
Title
International Index of Erectile Function-5 (IIEF-5)
Description
5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.
Time Frame
2 years
Title
International Index of Erectile Function-5 (IIEF-5)
Description
5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.
Time Frame
5 years
Title
Shor health scale (SHS)
Description
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Time Frame
2 months
Title
Shor health scale (SHS)
Description
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Time Frame
6 months
Title
Shor health scale (SHS)
Description
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Time Frame
1 year
Title
Shor health scale (SHS)
Description
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Time Frame
2 years
Title
Shor health scale (SHS)
Description
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Time Frame
5 years
Title
Öresland Score
Description
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Time Frame
2 months
Title
Öresland Score
Description
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Time Frame
6 months
Title
Öresland Score
Description
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Time Frame
1 year
Title
Öresland Score
Description
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Time Frame
2 years
Title
Öresland Score
Description
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Time Frame
5 years
Title
failure
Description
Extirpation of reconstruction or permanant stoma deviation
Time Frame
2 months
Title
failure
Description
Extirpation of reconstruction or permanant stoma deviation
Time Frame
6 months
Title
failure
Description
Extirpation of reconstruction or permanant stoma deviation
Time Frame
1 year
Title
failure
Description
Extirpation of reconstruction or permanant stoma deviation
Time Frame
2 years
Title
failure
Description
Extirpation of reconstruction or permanant stoma deviation
Time Frame
5 years
Title
reoperations
Description
number of reoperations
Time Frame
2 months
Title
reoperations
Description
number of reoperations
Time Frame
6 months
Title
reoperations
Description
number of reoperations
Time Frame
1 year
Title
reoperations
Description
number of reoperations
Time Frame
2 years
Title
reoperations
Description
number of reoperations
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anton Risto
Phone
0702510374
Email
anton.risto@liu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Pär Myrelid, Prof.
Phone
+46 0 10 1031581
Email
par.myrelid@liu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Nordenvall, Ass. Prof
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Chair
Facility Information:
Facility Name
Sahlgrenska Univercity Hospital
City
Gothenburg
ZIP/Postal Code
SE-413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Hermansson
Phone
+46 0 76 0401039
Facility Name
Linkoeping University hospital
City
Linköping
ZIP/Postal Code
58731
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anton Risto
Phone
0702510374
Email
anton.risto@liu.se
First Name & Middle Initial & Last Name & Degree
Pär Myrelid
Facility Name
Karolinska University Hospital
City
Solna
ZIP/Postal Code
se-171 76
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Nordenvall
Phone
+46 0 70 6579109
Facility Name
St. Mark's Hospital
City
London
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Deputy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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