Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0185146331
Study information
Scientific title
Acronym
Study hypothesis
To determine whether giving iron supplements to patients at the time of diagnosis of colorectal cancer increases or prevents the decrease in their haemoglobin levels and reduces allogeneic blood exposure.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cancer: Colorectal
Intervention
All patients seen in the outpatient clinic and scheduled for colorectal cancer surgery will be recruited. Patients will be randomised to receive iron supplements or nothing until 3 days prior to admission, so as not to interfere with bowel preparation. Blood tests including FBC, reticulocyte count, ferritin and plasma viscosity will be performed in clinic at 2 weeks and on the day of admission. During admission the details of the operation (type, surgeon, duration, blood loss) any transfusion and length of stay will be noted.
Intervention type
Supplement
Phase
Not Specified
Drug names
Iron supplements
Primary outcome measure
To determine whether giving iron supplements to patients at the time of diagnosis of colorectal cancer increases, or prevents the decrease, in their haemoglobin levels, and reduces allogeneic blood exposure.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/07/2001
Overall trial end date
30/06/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients seen in clinic with a diagnosis of colorectal cancer and fit for surgery will be eligible.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/07/2001
Recruitment end date
30/06/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
General Surgery Department
Plymouth
PL6 8DH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Plymouth Hospitals NHS Trust (UK), Own Account
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17535624
Publication citations
-
Results
Lidder PG, Sanders G, Whitehead E, Douie WJ, Mellor N, Lewis SJ, Hosie KB, Pre-operative oral iron supplementation reduces blood transfusion in colorectal surgery - a prospective, randomised, controlled trial., Ann R Coll Surg Engl, 2007, 89, 4, 418-421, doi: 10.1308/003588407X183364.