Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001281987
Ethics application status
Not yet submitted
Date submitted
13/12/2011
Date registered
14/12/2011
Date last updated
14/12/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of topical mesalazine over adenomas incidence in rectal stumps and ileal pouches of familial adenomatous polyposis patients submitted to colectomy.
Scientific title
In familial adenomatous polyposis patients submitted to total colectomy or proctocolectomy, will the use of 1g per day of mesalazine, as rectal foam, uncontrolled, reduce the incidence of new adenomas in the rectal stumps or ileal pouches?
Secondary ID [1] 273599 0
Nil
Universal Trial Number (UTN)
U1111-1126-3718
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adenomas incidence in rectal stumps and ileal pouches 279393 0
Familial adenomatous polyposis 279394 0
Condition category
Condition code
Oral and Gastrointestinal 285572 285572 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 285573 285573 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Human Genetics and Inherited Disorders 285574 285574 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mesalazine, 1g per day of rectal foam, for 12months
Intervention code [1] 283884 0
Prevention
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286133 0
New adenomas (larger than 5mm) incidence in the rectal stumps or ileal pouches, as assessed by endoscopy
Timepoint [1] 286133 0
At study entry and six and twelve months after mesalazine use
Secondary outcome [1] 295213 0
Dimension, morfology and grade of dysplasia of new adenomas.
Endoscopy will be performed every six months and all polyps larger than 5mm will be removed. Polyp (including adenomas) dimension will be assessed by endoscopy. All polyps will be sent for pathological examination and the morfology and grade of dysplasia of adenomas will be assessed according to the WHO classification.
Timepoint [1] 295213 0
At study entry and six and twelve months after mesalazine use
Secondary outcome [2] 295214 0
Proliferation index of the rectal stump or ileal pouch mucosa.
At each endoscopy, two mucosal biopsies will be performed at each quadrant of the rectal stump or ileal pouch. Proliferation index of the mucosa will be assessed by immunohistochemistry.
Timepoint [2] 295214 0
At study entry and six and twelve months after mesalazine use
Secondary outcome [3] 295215 0
Nuclear concentration of beta-catenin in colonocytes or enterocytes.
At each endoscopy, two mucosal biopsies will be performed at each quadrant of the rectal stump or ileal pouch. Nuclear concentration of beta-catenin in colonocytes or enterocytes will be assessed by immunohistochemistry.
Timepoint [3] 295215 0
At study entry and six and twelve months after mesalazine use

Eligibility
Key inclusion criteria
Familial adenomatous polyposis patients with an identified APC gene mutation, submitted to total colectomy with ileorectal anastomosis or to total proctocolectomy with ileal pouch and with adenomas found in the rectal stump or ileal pouch in the year before study inclusion. Patients have to be under endoscopic surveillance every six months for at least one year prior to study inclusion, with endoscopic removal of all polyps larger than 5mm and pathological exam of all removed polyps.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give free informed consent; Personal history of inflammatory bowel disease; Cancer or high grade dysplasia in the rectal stump or ileal pouch in the year preceding study inclusion; Renal and/or hepatic failure, acute or chronic; Salycilates allergy; Aspirin, non-steroid anti-inflammatory drugs or COX2 inhibitors use in the three months prior to study inclusion

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 4010 0
Portugal
State/province [1] 4010 0

Funding & Sponsors
Funding source category [1] 284368 0
Hospital
Name [1] 284368 0
Instituto Portugues de Oncologia de Lisboa, Francisco Gentil, EPE
Country [1] 284368 0
Portugal
Primary sponsor type
Individual
Name
Isadora Rosa
Address
Servico de Gastrenterologia do IPOLFG, EPE
Rua Professor Lima Basto
1099-023 Lisboa
Country
Portugal
Secondary sponsor category [1] 283306 0
None
Name [1] 283306 0
Address [1] 283306 0
Country [1] 283306 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286329 0
Ethics committee address [1] 286329 0
Ethics committee country [1] 286329 0
Date submitted for ethics approval [1] 286329 0
16/12/2011
Approval date [1] 286329 0
Ethics approval number [1] 286329 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33528 0
Address 33528 0
Country 33528 0
Phone 33528 0
Fax 33528 0
Email 33528 0
Contact person for public queries
Name 16775 0
Isadora Alexandra da Luz Rosa
Address 16775 0
Servico de Gastrenterologia do IPOLFG, EPE
Rua Professor Lima Basto
1099-023 Lisboa
Country 16775 0
Portugal
Phone 16775 0
+351217200418
Fax 16775 0
Email 16775 0
isaalr9@netcabo.pt
Contact person for scientific queries
Name 7703 0
Isadora Alexandra da Luz Rosa
Address 7703 0
Servico de Gastrenterologia do IPOLFG, EPE
Rua Professor Lima Basto
1099-023 Lisboa
Country 7703 0
Portugal
Phone 7703 0
+351217200418
Fax 7703 0
Email 7703 0
isaalr9@netcabo.pt

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.