Recurrent colorectal adenomas Cancer Malignant neoplasm of rectosigmoid junction
Conditions
Interventions
Arm A: aspirin and folate
Arm B: aspirin and placebo folate
Arm C: placebo aspirin and folate
Arm D: placebo aspirin and placebo folate
Aspirin 300 mg E.C/day
folate 500 ug/day
Sponsors
Cancer Research UK (CRUK) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients who developed one or more recurrent colorectal adenomas or cancers | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of recurrent adenomas detected during follow-up 2. Percentage of patients who developed advanced colorectal neoplasia during follow-up | — |
Countries
Denmark, United Kingdom
Outcome results
None listed