sporadic colorectal adenoma sporadic colorectal adenomatous polyps
Conditions
Interventions
Treatment with 3.0 g mesalazine or placebo once daily for 6 months. At baseline
and after 6 months of treatment, a sigmoidoscopy will be performed and biopsies
of normal appearing sigmoid and rectal
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Within 6 months before study entry having undergone complete colonoscopy with polypectomy for removal of sporadic adenomatous polyps. This should be 2 or more adenomas, irrespective of size, and/or one adenoma with a diameter of at least 1 cm and/or with proximal localization and/or with villous aspects or high-grade dysplasia. - age 50-75 years
Exclusion criteria
Exclusion criteria: - inflammatory bowel disease - familial colorectal cancer syndrome - history of colorectal carcinoma - history of surgery to the large bowel (except appendectomy) - chronic renal insufficiency - chronic hepatic insufficiency - allergy to salicylates - asthma - diabetes mellitus - coagulation disorder or anticoagulant use, which cannot be temporarily discontinued - regular intake of thiopurines, methotrexate or cyclosporin - prescription use of aspirin (high- and low-dose) or other NSAIDs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect of treatment with mesalazine on apoptotic and proliferation indices and distribution of proliferating cells relative to the placebo group. | — |
Secondary
| Measure | Time frame |
|---|---|
| The effect of treatment with mesalazine on the mRNA and protein expression of β- catenin signalling pathway components relative to the placebo group. | — |
Countries
Netherlands
Outcome results
None listed