Effect of topical mesalazine over adenomas incidence in rectal stumps and ileal pouches of familial adenomatous polyposis patients submitted to colectomy.
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?
Isadora Rosa
15 participants
Jun 1, 2012
Interventional
Conditions
Summary
In patients with genetically confirmed diagnosis of familial adenomatous polyposis, and adenomas of the rectal stump or ileal pouch found during surveillance after colectomy, we hypothesized that topical mesalazine may reduce the incidence of new adenomas.
Eligibility
Inclusion Criteria1
- 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 Criteria1
- 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
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Interventions
Mesalazine, 1g per day of rectal foam, for 12months
Locations(1)
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ACTRN12611001281987