Ulcerative ColitisCRUISENCT05628701
Colectomy Reconstruction for Ulcerative Colitis, Ileorectal Anastomosis vs Ileal Pouch-Anal Anastomosis in Ulcerative Colitis.
A study testing Ileorectal anastomosis (IRA), Ileal pouch anal anastomosis (IPAA) and ileostomy in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by Linkoeping University at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ulcerative Colitis, Inflammatory Bowel Diseases, Ileostomy - Stoma
- What is being tested?
- Ileorectal anastomosis (IRA), Ileal pouch anal anastomosis (IPAA) and ileostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 4 Apr 2017to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Sweden3 sites, 3 recruiting
- Recruiting
Sahlgrenska Univercity Hospital
Gothenburg, SE-413 45
Maria Hermansson, +46 0 76 0401039
- Recruiting
Linkoeping University hospital
Linköping, 58731
Anton Risto, 0702510374, anton.risto@liu.se
Pär Myrelid
- Recruiting
Karolinska University Hospital
Solna, se-171 76
Caroline Nordenvall, +46 0 70 6579109
United Kingdom1 site, 1 recruiting
- Recruiting
St. Mark's Hospital
London, HA1 3UJ
Mohammed Deputy
About this study
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.
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.
- Being tested
- Ileorectal anastomosis (IRA), Ileal pouch anal anastomosis (IPAA), ileostomy
- Keywords
- Ulcerative Colitis,, Colectomy, Reconstruction
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ileorectal anastomosis (IRA)Procedure or surgery
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))
Ileal pouch anal anastomosis (IPAA)Procedure or surgery
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)).
ileostomyProcedure or surgery
no reconstruction is performed and the patient is left with his/her ileostomy
| Study group | Role | What they receive |
|---|---|---|
| IPAA CRUISE | Experimental | Patients eligible for both operations choosing ileal pouch anal anastomosis. Receives: Procedure: Ileal pouch anal anastomosis (IPAA) |
| IRA CRUISE | Experimental | Patients eligible for both operations choosing ileorectal anastomosis. Receives: Procedure: Ileorectal anastomosis (IRA) |
| IRA Control | Active comparator | Patients only eligible for ileorectal anastomosis. Receives: Procedure: Ileorectal anastomosis (IRA) |
| IPAA Control | Active comparator | Patients only eligible for ileal pouch anal anastomosis. Receives: Procedure: Ileal pouch anal anastomosis (IPAA) |
| Ileostomy Control | Active comparator | Patients who decline reconstruction. Receives: Procedure: ileostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
yes/no question if the patient is satisfied with his/her choice of operation
Measured: 2months
Patient satisfaction
yes/no question if the patient is satisfied with his/her choice of operation
Measured: 1year
Patient satisfaction
yes/no question if the patient is satisfied with his/her choice of operation
Measured: 5 years
Secondary outcomes (35)
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
Measured: 2 months
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
Measured: 6 months
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
Measured: 1 year
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
Measured: 2 years
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
Measured: 5 years
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.
Measured: 2months
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.
Measured: 6months
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.
Measured: 1 year
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.
Measured: 2 years
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.
Measured: 5 years
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.
Measured: 2 months
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.
Measured: 6 months
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.
Measured: 1 year
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.
Measured: 2 years
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.
Measured: 5 years
Shor health scale (SHS)
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Measured: 2 months
Shor health scale (SHS)
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Measured: 6 months
Shor health scale (SHS)
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Measured: 1 year
Shor health scale (SHS)
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Measured: 2 years
Shor health scale (SHS)
IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.
Measured: 5 years
Öresland Score
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Measured: 2 months
Öresland Score
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Measured: 6 months
Öresland Score
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Measured: 1 year
Öresland Score
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Measured: 2 years
Öresland Score
Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.
Measured: 5 years
failure
Extirpation of reconstruction or permanant stoma deviation
Measured: 2 months
failure
Extirpation of reconstruction or permanant stoma deviation
Measured: 6 months
failure
Extirpation of reconstruction or permanant stoma deviation
Measured: 1 year
failure
Extirpation of reconstruction or permanant stoma deviation
Measured: 2 years
failure
Extirpation of reconstruction or permanant stoma deviation
Measured: 5 years
reoperations
number of reoperations
Measured: 2 months
reoperations
number of reoperations
Measured: 6 months
reoperations
number of reoperations
Measured: 1 year
reoperations
number of reoperations
Measured: 2 years
reoperations
number of reoperations
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start4 Apr 2017
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Karolinska University Hospital, Göteborg University, University College London Hospitals
- Responsible party
- Principal investigator, Anton Risto, Linkoeping University
- Investigators
- Caroline Nordenvall, Ass. Prof, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628701
- Sponsor's protocol ID
- 2017/124-31/2
- Acronym
- CRUISE
- Status last verified
- Nov 2022
- First submitted
- 28 Oct 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Risto A, Nordenvall C, Deputy M, Hermanson M, Lindforss U, Block M, Faiz O, Myrelid P. 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. (CRUISE-study). BMC Surg. 2023 Apr 21;23(1):96. doi: 10.1186/s12893-023-01984-x.
PubMed 37085812
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05628701
- Acronym / sponsor ID
- CRUISE / 2017/124-31/2
- Keywords
- Ulcerative Colitis,, Colectomy, Reconstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Karolinska University Hospital, Göteborg University, University College London Hospitals
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- 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
| Arm | Type | Receives |
|---|---|---|
| IPAA CRUISE | Experimental | Procedure: Ileal pouch anal anastomosis (IPAA)Patients eligible for both operations choosing ileal pouch anal anastomosis. |
| IRA CRUISE | Experimental | Procedure: Ileorectal anastomosis (IRA)Patients eligible for both operations choosing ileorectal anastomosis. |
| IRA Control | Active comparator | Procedure: Ileorectal anastomosis (IRA)Patients only eligible for ileorectal anastomosis. |
| IPAA Control | Active comparator | Procedure: Ileal pouch anal anastomosis (IPAA)Patients only eligible for ileal pouch anal anastomosis. |
| Ileostomy Control | Active comparator | Procedure: ileostomyPatients who decline reconstruction. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | IRA CRUISE, IRA Control |
| 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 or surgery | IPAA CRUISE, IPAA Control |
| ileostomyno reconstruction is performed and the patient is left with his/her ileostomy | Procedure or surgery | Ileostomy Control |
Primary outcome
Patient satisfaction
Time frame: 2months
yes/no question if the patient is satisfied with his/her choice of operation
Patient satisfaction
Time frame: 1year
yes/no question if the patient is satisfied with his/her choice of operation
Patient satisfaction
Time frame: 5 years
yes/no question if the patient is satisfied with his/her choice of operation
35 secondary outcomes
SF-36(short form-36 item)
Time frame: 2 months
SF-36(short form-36 item)
Time frame: 6 months
SF-36(short form-36 item)
Time frame: 1 year
SF-36(short form-36 item)
Time frame: 2 years
SF-36(short form-36 item)
Time frame: 5 years
Female Sexual Function Index-6 (FSFI-6)
Time frame: 2months
Female Sexual Function Index-6 (FSFI-6)
Time frame: 6months
Female Sexual Function Index-6 (FSFI-6)
Time frame: 1 year
Female Sexual Function Index-6 (FSFI-6)
Time frame: 2 years
Female Sexual Function Index-6 (FSFI-6)
Time frame: 5 years
International Index of Erectile Function-5 (IIEF-5)
Time frame: 2 months
International Index of Erectile Function-5 (IIEF-5)
Time frame: 6 months
International Index of Erectile Function-5 (IIEF-5)
Time frame: 1 year
International Index of Erectile Function-5 (IIEF-5)
Time frame: 2 years
International Index of Erectile Function-5 (IIEF-5)
Time frame: 5 years
Shor health scale (SHS)
Time frame: 2 months
Shor health scale (SHS)
Time frame: 6 months
Shor health scale (SHS)
Time frame: 1 year
Shor health scale (SHS)
Time frame: 2 years
Shor health scale (SHS)
Time frame: 5 years
Öresland Score
Time frame: 2 months
Öresland Score
Time frame: 6 months
Öresland Score
Time frame: 1 year
Öresland Score
Time frame: 2 years
Öresland Score
Time frame: 5 years
failure
Time frame: 2 months
failure
Time frame: 6 months
failure
Time frame: 1 year
failure
Time frame: 2 years
failure
Time frame: 5 years
reoperations
Time frame: 2 months
reoperations
Time frame: 6 months
reoperations
Time frame: 1 year
reoperations
Time frame: 2 years
reoperations
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Derived from this study: PubMed 37085812Risto A, Nordenvall C, Deputy M, Hermanson M, Lindforss U, Block M, Faiz O, Myrelid P. 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. (CRUISE-study). BMC Surg. 2023 Apr 21;23(1):96. doi: 10.1186/s12893-023-01984-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caroline Nordenvall, Ass. Prof study chair
Karolinska Institutet
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ileorectal anastomosis (IRA), Ileal pouch anal anastomosis (IPAA) and ileostomy in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by Linkoeping University at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anton Risto (0702510374, anton.risto@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: 2months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05628701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.