Randomized clinical trial comparing two intravenous iron regimens in the postoperative period  of colorectal cancer surgery: study protocol
Laso, MJ, Caló N, Martínez F, Carol F, Valle A, Vives R
Introduction
In a recent retrospective observational study performed at our hospital we observed that the prevalence of anaemia and/or iron deficiency in patients diagnosed of colorectal cancer (CRC) is > 50%. After surgery, this percentage increases to more than 80% due to intra and postoperative blood loss. Several guidelines advocate for the treatment of postoperative anaemia in these patients in order to prevent complications and allogeneic blood transfusions. However, there are no publications to give us light about the effectiveness of intravenous iron (IVI) administration after CRC surgery and which is the optimal dose and regimen. We have started a clinical trial with the objective to compare the effectiveness of 1g of carboximaltose iron against fractionated sacarose iron 200g/48h for the postoperative anaemia, by measuring the change of Hb (haemoglobin) levels from postoperative day 1 to day 30.
Methods
We designed an open label randomized controlled trial to compare two postoperative IVI  treatment regimens. Patients above 18 years old undergoing CRC surgery, with Hb< 11g/dL on postoperative day 1 are be randomly assigned to receive either 1 g of carboximaltose iron (single dose) or 200 g/48h. The main study variable is the change of Hb levels between postoperative day 1 and day 30. Secondary variables include the number of transfusions, total iron dose received during the first thirty days, number of patients that normalize Hb levels, number of complications or adverse effects and changes in patient’s quality of life. It has been estimated that a sample of 48 patients per group will allow detecting a difference of 0.75 g/dL in Hb in the change in Hb levels from day 1 to day 30.
Results
Inclusion of patients started on September 2015. At the moment, 48 patients have been included and the end of recruitment is expected on September 2017.
Conclusions
A previous observational study showed that the prevalence of anaemia in CRC patients is high. An independent study to generate clinical evidence on the effectiveness of different postoperative IVI regimens is ongoing.

Randomized clinical trial comparing two patterns of intravenous iron in the postoperative period in colon cancer surgery