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Effect of topical mesalazine over adenomas incidence in rectal stumps and ileal pouches of familial adenomatous polyposis patients submitted to colectomy.

Phase 2
Conditions
Adenomas incidence in rectal stumps and ileal pouches
Familial adenomatous polyposis
Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer - Bowel - Back passage (rectum) or large bowel (colon)
Human Genetics and Inherited Disorders - Other human genetics and inherited disorders
Registration Number
ACTRN12611001281987
Lead Sponsor
Isadora Rosa
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
All
Target Recruitment
15
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.

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

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
ew adenomas (larger than 5mm) incidence in the rectal stumps or ileal pouches, as assessed by endoscopy[At study entry and six and twelve months after mesalazine use]
Secondary Outcome Measures
NameTimeMethod
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