1. Multicentre randomized controlled trial comparing ferric(III)carboxymaltose infusion with oral iron supplementation in the treatment of preoperative anaemia in colorectal cancer patients.
- Author
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Borstlap WAA, Buskens CJ, Tytgat KMAJ, Tuynman JB, Consten ECJ, Tolboom RC, Heuff G, van Geloven N, van Wagensveld BA, C A Wientjes CA, Gerhards MF, de Castro SMM, Jansen J, van der Ven AWH, van der Zaag E, Omloo JM, van Westreenen HL, Winter DC, Kennelly RP, Dijkgraaf MGW, Tanis PJ, and Bemelman WA
- Subjects
- Administration, Oral, Adolescent, Adult, Aged, Aged, 80 and over, Anemia, Iron-Deficiency etiology, Clinical Protocols, Colorectal Neoplasms complications, Dietary Supplements, Female, Ferric Compounds therapeutic use, Ferrous Compounds therapeutic use, Fumarates therapeutic use, Hematinics therapeutic use, Humans, Infusions, Intravenous, Male, Maltose administration & dosage, Maltose therapeutic use, Middle Aged, Treatment Outcome, Young Adult, Anemia, Iron-Deficiency drug therapy, Colorectal Neoplasms surgery, Ferric Compounds administration & dosage, Ferrous Compounds administration & dosage, Fumarates administration & dosage, Hematinics administration & dosage, Maltose analogs & derivatives, Preoperative Care methods
- Abstract
Background: At least a third of patients with a colorectal carcinoma who are candidate for surgery, are anaemic preoperatively. Preoperative anaemia is associated with increased morbidity and mortality. In general practice, little attention is paid to these anaemic patients. Some will have oral iron prescribed others not. The waiting period prior to elective colorectal surgery could be used to optimize a patients' physiological status. The aim of this study is to determine the efficacy of preoperative intravenous iron supplementation in comparison with the standard preoperative oral supplementation in anaemic patients with colorectal cancer., Methods/design: In this multicentre randomized controlled trial, patients with an M0-staged colorectal carcinoma who are scheduled for curative resection and with a proven iron deficiency anaemia are eligible for inclusion. Main exclusion criteria are palliative surgery, metastatic disease, neoadjuvant chemoradiotherapy (5 × 5 Gy = no exclusion) and the use of Recombinant Human Erythropoietin within three months before inclusion or a blood transfusion within a month before inclusion. Primary endpoint is the percentage of patients that achieve normalisation of the haemoglobin level between the start of the treatment and the day of admission for surgery. This study is a superiority trial, hypothesizing a greater proportion of patients achieving the primary endpoint in favour of iron infusion compared to oral supplementation. A total of 198 patients will be randomized to either ferric(III)carboxymaltose infusion in the intervention arm or ferrofumarate in the control arm. This study will be performed in ten centres nationwide and one centre in Ireland., Discussion: This is the first randomized controlled trial to determine the efficacy of preoperative iron supplementation in exclusively anaemic patients with a colorectal carcinoma. Our trial hypotheses a more profound haemoglobin increase with intravenous iron which may contribute to a superior optimisation of the patient's condition and possibly a decrease in postoperative morbidity., Trial Registration: ClincalTrials.gov: NCT02243735 .
- Published
- 2015
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