A multi-centre double blind randomised controlled trial of aspirin and/or folate supplementation for the prevention of recurrent colorectal adenomas

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Richard Logan
Scientific

School of Community Health Sciences
Medical School
University of Nottingham
Nottingham
NG7 2UH
United Kingdom

Phone	+44 (0)115 823 0452
Email	Richard.Logan@nottingham.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A multi-centre double blind randomised controlled trial of aspirin and/or folate supplementation for the prevention of recurrent colorectal adenoma
Study objectives	To determine whether aspirin (300 mg/day) and/or folic acid (0.5 mg/day) could be used to prevent further colorectal adenomas in the high risk group of patients with previous colorectal adenomas removed by colonoscopy.
Ethics approval(s)	1. LREC approval (Nottingham): gained on 19/11/98 (ref: EC98/203) 2. MREC approval (Trent): gained on 02/12/03 (ref: 98/4/055)
Health condition(s) or problem(s) studied	Recurrent colorectal adenomas
Intervention	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
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Aspirin, folate
Primary outcome measure(s)	Percentage of patients who developed one or more recurrent colorectal adenomas or cancers
Key secondary outcome measure(s)	1. Number of recurrent adenomas detected during follow-up 2. Percentage of patients who developed advanced colorectal neoplasia during follow-up
Completion date	01/07/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1000
Key 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
Key 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
Date of first enrolment	01/12/1997
Date of final enrolment	01/07/2005

School of Community Health Sciences

Nottingham
NG7 2UH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2008		Yes	No
Plain English results				No	Yes

18/10/2018: Cancer Research UK lay results summary link added to Results (plain English)