| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN61221573 |
| Date ISRCTN assigned | 30/09/2005 |
| Local reference number(s) | N0185146331 |
| Public title | A Prospective Randomised Controlled Trial of Iron Supplementation in Patients Scheduled for Colorectal Cancer Surgery |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cancer: Colorectal |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | All patients seen in clinic with a diagnosis of colorectal cancer and fit for surgery will be eligible. 60 participants in total.
|
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/07/2001 |
| Anticipated end date | 30/06/2004 |
| Status of trial | Completed |
| Target number of participants | 60 |
| Interventions | 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. |
| 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. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Plymouth Hospitals NHS Trust
Own Account
|
| Sponsor name | Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr KB hosie |
| Contact details | General Surgery Dept.
Level 07
Derriford Hospital
Derriford
Plymouth
United Kingdom
PL6 8DH |
| Contact telephone | +44 (0)1752 777111 |
| Contact fax | +44 (0)1752 768976 |
| Contact email | GeneralSurgerySupportSecretary@phnt.swest.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN61221573 |
| Date last extracted from ISRCTN register | 17/04/2008 |
