title: Multicentre randomized controlled trial comparing ferric(III)carboxymaltose infusion with oral iron supplementation in the treatment of preoperative anaemia in colorectal cancer patients.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClincalTrials.gov: NCT02243735 .
authors.affiliation: Department of Surgery, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands. w.a.borstlap@amc.uva.nl.
authors.forename: W A A
authors.initials: WAA
authors.lastname: Borstlap
authors.affiliation: Department of Surgery, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: C J
authors.initials: CJ
authors.lastname: Buskens
authors.affiliation: Department of Gastroenterology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: K M A J
authors.initials: KMAJ
authors.lastname: Tytgat
authors.affiliation: Department of Surgery, VU University Medical Centre, Amsterdam, The Netherlands.
authors.forename: J B
authors.initials: JB
authors.lastname: Tuynman
authors.affiliation: Department of Surgery, Meander Medical Centre, Amersfoort, The Netherlands.
authors.forename: E C J
authors.initials: ECJ
authors.lastname: Consten
authors.affiliation: Department of Surgery, Meander Medical Centre, Amersfoort, The Netherlands.
authors.forename: R C
authors.initials: RC
authors.lastname: Tolboom
authors.affiliation: Department of Surgery, Spaarne Hospital, Hoofddorp, The Netherlands.
authors.forename: G
authors.initials: G
authors.lastname: Heuff
authors.affiliation: Department of Surgery, Tergooi Hospital, Hilversum, The Netherlands.
authors.forename: N
authors.initials: N
authors.lastname: van Geloven
authors.affiliation: Department of Surgery, Sint Lucas Andreas Hospital, Amsterdam, The Netherlands.
authors.forename: B A
authors.initials: BA
authors.lastname: van Wagensveld
authors.affiliation: Department of Gastroenterology, Sint Lucas Andreas Hospital, Amsterdam, The Netherlands.
authors.forename: C A
authors.initials: CA
authors.lastname: C A Wientjes
authors.affiliation: Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: M F
authors.initials: MF
authors.lastname: Gerhards
authors.affiliation: Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: S M M
authors.initials: SMM
authors.lastname: de Castro
authors.affiliation: Department of Gastroenterology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: J
authors.initials: J
authors.lastname: Jansen
authors.affiliation: Department of Surgery, Flevo Hospital, Almere, The Netherlands.
authors.forename: A W H
authors.initials: AWH
authors.lastname: van der Ven
authors.affiliation: Department of Surgery, Gelre Hospital, Apeldoorn, The Netherlands.
authors.forename: E
authors.initials: E
authors.lastname: van der Zaag
authors.affiliation: Department of Surgery, Gelre Hospital, Apeldoorn, The Netherlands.
authors.forename: J M
authors.initials: JM
authors.lastname: Omloo
authors.affiliation: Department of Surgery, Isala Hospital, Zwolle, The Netherlands.
authors.forename: H L
authors.initials: HL
authors.lastname: van Westreenen
authors.affiliation: Department of Surgery, St. Vincent's Hospital, Dublin, Ireland.
authors.forename: D C
authors.initials: DC
authors.lastname: Winter
authors.affiliation: Department of Surgery, St. Vincent's Hospital, Dublin, Ireland.
authors.forename: R P
authors.initials: RP
authors.lastname: Kennelly
authors.affiliation: Clinical Research Unit, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: M G W
authors.initials: MGW
authors.lastname: Dijkgraaf
authors.affiliation: Department of Surgery, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: P J
authors.initials: PJ
authors.lastname: Tanis
authors.affiliation: Department of Surgery, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: W A
authors.initials: WA
authors.lastname: Bemelman
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018798:Anemia, Iron-Deficiency / Q000188:drug therapy* / Q000209:etiology; D002985:Clinical Protocols; D015179:Colorectal Neoplasms / Q000150:complications / Q000601:surgery*; D019587:Dietary Supplements; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage* / Q000627:therapeutic use; D005296:Ferrous Compounds / Q000008:administration & dosage* / Q000627:therapeutic use; D005650:Fumarates / Q000008:administration & dosage* / Q000627:therapeutic use; D006397:Hematinics / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008320:Maltose / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008875:Middle Aged; D011300:Preoperative Care / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005290:Ferric Compounds; D005296:Ferrous Compounds; D005650:Fumarates; D006397:Hematinics; C522335:ferric carboxymaltose; D008320:Maltose