Not Yet RecruitingPhase 2Phase 3ACTRN12611001281987

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?

Sponsor

Isadora Rosa

Enrollment

15 participants

Start Date

Jun 1, 2012

Study Type

Interventional

Conditions

Adenomas incidence in rectal stumps and ileal pouches

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether applying mesalazine (an anti-inflammatory drug) directly to the remaining rectum or ileal pouch can reduce the number of precancerous polyps in adults aged 18+ with familial adenomatous polyposis who have had their colon removed. Participants must have a confirmed APC gene mutation, be under regular endoscopic surveillance, and have had polyps found in the past year. Those with inflammatory bowel disease, cancer in the pouch or rectum, kidney or liver failure, or salicylate allergy are excluded.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Mesalazine, 1g per day of rectal foam, for 12months

Locations(1)

Portugal

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ACTRN12611001281987