A multi-centre double blind randomised controlled trial of aspirin and/or folate supplementation for the prevention of recurrent colorectal adenomas
- Conditions
- CancerRecurrent colorectal adenomasMalignant neoplasm of rectosigmoid junction
- Registration Number
- ISRCTN22669537
- Lead Sponsor
- Cancer Research UK (CRUK) (UK)
- Brief Summary
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18022173
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1000
Eligible patients who have had:
1. Removal of adenomas greater than 0.5 cm after fixation or adenomas greater than 0.7 cm at the time of removal, within the last six months
2. A previous history of removal of such adenomas and have had adenoma of any size removed in the six months prior to recruitment These adenomas will be histologically confirmed and removed by either colonoscopy, flexi-sigmoidoscopy or via Transanal Endoscopic Microsurgery (TEMS) procedure
1. Over 75 years at time of recruitment
2. Serious medical conditions likely to preclude successful completion of the trial
3. Existing use of prescribed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) including aspirin
4. Known aspirin intolerance or sensitivity
5. Active bleeding disorders or upper Gastrointestinal (GI) ulceration, including use of anticoagulants
6. Previous resection of the large bowel
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients who developed one or more recurrent colorectal adenomas or cancers
- Secondary Outcome Measures
Name Time Method 1. Number of recurrent adenomas detected during follow-up<br>2. Percentage of patients who developed advanced colorectal neoplasia during follow-up