A Prospective Randomised Controlled Trial of Iron Supplementation in Patients Scheduled for Colorectal Cancer Surgery

ISRCTN	ISRCTN61221573
DOI	https://doi.org/10.1186/ISRCTN61221573
Protocol serial number	N0185146331
Sponsor	Department of Health
Funder	Plymouth Hospitals NHS Trust (UK), Own Account

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr KB Hosie
Scientific

General Surgery Department
Level 07
Derriford Hospital
Derriford
Plymouth
PL6 8DH
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/06/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	60
Key inclusion criteria	All patients seen in clinic with a diagnosis of colorectal cancer and fit for surgery will be eligible.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/07/2001
Date of final enrolment	30/06/2004

General Surgery Department

Plymouth
PL6 8DH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2007		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes