A Randomised Double-Blind Multicentre Placebo-Controlled Study to Investigate the Effect of Ranitidine on the Post-Operative Infection Rate and Survival Rate of Patients Undergoing Surgery for Colorectal Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Colon, Rectum
Intervention	1. Group A: Intravenous ranitidine, 100 mg, administered twice daily for 5 days or until oral treatment is tolerated, followed by oral ranitidine, 150 mg twice daily until death or for a period of 5 years. 2. Group B: Intravenous placebo, 100 mg, administered twice daily for 5 days or until oral treatment is tolerated, followed by oral placebo, 150 mg twice daily until death or for a period of 5 years.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Ranitidine
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2002

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex
Key inclusion criteria	1. Aged >18 years 2. Diagnosis of colorectal cancer 3. This is the first operation for cancer and the life expectancy of the patient is at least 3 months at the time of surgery 4. No concurrent chronic modulating therapy with systemic steroids, antiviral agents or other known immunomodulating drugs 5. No systemic antimicrobial agents in the 48 h prior to entry into the study 6. Not currently or planning to undergo chemotherapy, radiotherapy or any other therapy for cancer 7. No medical contraindications to protocol treatments
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2002
Date of final enrolment	31/12/2002

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

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