A Prospective Randomised Controlled Trial of Iron Supplementation in Patients Scheduled for Colorectal Cancer Surgery
| ISRCTN | ISRCTN61221573 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61221573 |
| Secondary identifying numbers | N0185146331 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 17/09/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr KB Hosie
Scientific
Scientific
General Surgery Department
Level 07
Derriford Hospital
Derriford
Plymouth
PL6 8DH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/07/2001 |
| Completion date | 30/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
General Surgery Department
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Plymouth Hospitals NHS Trust (UK), Own Account
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2007 | Yes | No |
