Condition category
Cancer
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
17/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr KB Hosie

ORCID ID

Contact details

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

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17535624

Publication citations

  1. 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.

Additional files

Editorial Notes