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?

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001281987

Enrollment

Registered

2011-12-14

Start date

2012-06-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

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

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results