PiCoC

• Research type

  Research Study

• Full title

  An Open Label Randomised Trial to Assess the Efficacy of Post-Operative Ferric Maltol Vs Standard Care for Anaemia Following Colorectal Cancer Surgery

• IRAS ID

  1003910

• Contact name

  Nuha Yassin

• Contact email

  nuha.yassin@nhs.net

• Sponsor organisation

  The Royal Wolverhampton NHS Trust

• Eudract number

  2021-006004-32

• ISRCTN Number

  ISRCTN12290106

• Research summary

  Colorectal cancer is associated with iron deficiency anaemia in 40-60% of cases which can lead to poorer post-operative outcomes such as higher complication rates, increased length of stay and reduced survival. There has been a recent shift towards the correction of preoperative anaemia in order to optimize perioperative outcomes but despite improvements in preoperative haemoglobin there exists a group of patients who develop worsening or recurrent anaemia in the post-operative period. Without intervention up to 90% of patients in the immediate postoperative period may develop anaemia. This is not unexpected given the peri‐operative blood loss; poor nutritional intake in the postoperative period; and the frequent blood sampling for laboratory tests. Previous trials have demonstrated that despite preoperative intravenous iron therapy 75% of patients remain anaemic at the time of their colorectal cancer operation. Studies have identified that traditional oral ferrous iron supplementation is largely ineffective for the treatment of postoperative anaemia. However, a newer oral iron preparation - ferric maltol (Ferracru) has been found to be better tolerated and more efficacious than ferrous iron. This study aims to evaluate whether the use of iron supplementation in the form of Feraccru could lead to a more sustained or improved response in haemoglobin if given after a colorectal cancer operation. This trial will run as a feasibility study to assess the proposed design. Anaemic colorectal cancer patients treated with preoperative intravenous iron will be randomised in an open label design to receive Ferric maltol (intervention group) or standard care (control group) postoperatively. Outcome measures will include a comparison of change in blood indices, quality of life, allogenic red blood transfusion rates and postoperative complications between groups. Follow up will continue until the first postoperative outpatient visit at approximately 12 weeks following discharge.

• REC name

  Wales REC 2

• REC reference

  22/WA/0035

• Date of REC Opinion

  18 Feb 2022

• REC opinion

  Further Information Favourable Opinion