IVICA - Long term follow up and outcomes
Research type
Research Study
Full title
Intravenous Iron in Colorectal Associated Anaemia - Long term Follow up and Outcomes.
IRAS ID
253792
Contact name
Edward Dickson
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Research Summary
The IVICA trial previously assessed the efficacy of intravenous (injected) iron compared to oral iron to treat anaemia (low blood count) in patients about to undergo surgery for colorectal cancer. IVICA was a randomised study and recruited a total of 116 patients. Half of these received intravenous iron and half received oral iron before their operation. These individuals were then followed up until their outpatient appointment at which point the study closed. We are now interested in whether there were any differences in long term health outcomes between the two groups. This follow up study will therefore look to revisit patient records for the 116 IVICA patients. We will collect data to assess whether there are differences in long term survival or cancer recurrence between those who received intravenous or oral iron. We will also assess whether they had a recurrence of their anaemia and whether they received any further iron therapy since their involvement in IVICA. This will be an observational study. We will not be contacting patients to provide any additional information and they will not be asked to undertake any further interventions. Data will only be collected from normal clinical encounters. Follow up data will be collected in one round of data collection up until the last participant from IVICA reaches their 5 year follow up period (July 2019) or until the death of the patient, whichever is sooner. As IVICA was a multicentre study we will also be contacting previous participating centres though their original principal investigators to submit data for their own patients. All data will be anonymised before transfer outside any of these trusts.
Summary of Results
We studied the long term outcomes of patients who had taken part in a previous clinical trial. In the previous trial all of these patients had been given either iron tablets or iron injections to treat their low blood count before their bowel cancer operation. We were now interested to see if there were any differences in the long term outcomes of these two groups of patients in terms of death rates or return of their cancer.
In total we studied 110 of the 116 original patients. The average time since their operation was 61 months. We found that death rates were the same over the past 5 years. We also found that rates of cancer recurrence were the same. For some patients the iron treatment had completely corrected their low blood count before their operation. In these patients the rates of death were 3 times lower than the other patients. This had lead us to believe that there may be a benefit to survival if we can completely correct a low blood count before a bowel cancer operation.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
19/NE/0127
Date of REC Opinion
26 Apr 2019
REC opinion
Further Information Favourable Opinion