RESUMEN
AIM: Preoperative anaemia is associated with increased morbidity and mortality. The aim of this systematic review is to evaluate the efficacy of preoperative iron supplementation in the treatment of anaemia, and its effect on the postoperative recovery of patients undergoing surgery for colorectal carcinoma. METHOD: This systematic review was performed using MEDLINE, EMBASE and the Cochrane library to assess current evidence on the role of iron supplementation in the treatment of preoperative anaemia. Our main outcomes were absolute increase in haemoglobin, blood transfusion rate and postoperative morbidity. Main inclusion criteria were: preoperative iron supplementation, presence of colorectal carcinoma and elective surgery. The Downs-Black questionnaire was used for quality assessment of the included studies. RESULTS: Of the 605 studies analysed, seven, three randomized controlled trials and four cohort studies, were included. Despite iron supplementation, the three randomized controlled trials showed a decrease in haemoglobin level. This was contrary to the four cohort studies which all showed a significant increase. All studies showed a decreased blood transfusion rate following iron supplementation. None of the included studies assessed postoperative morbidity. Due to heterogeneity in study design, duration of treatment, dosages and variation in iron substrates, we were unable to perform a meta-analysis. CONCLUSION: In anaemic patients who require surgery for colorectal carcinoma, current evidence is of inadequate quality to draw a definitive conclusion on the efficacy of the various measures to treat preoperative anaemia.
Asunto(s)
Anemia Ferropénica/tratamiento farmacológico , Neoplasias Colorrectales/complicaciones , Hierro/uso terapéutico , Periodo Preoperatorio , Oligoelementos/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Anemia Ferropénica/etiología , Transfusión Sanguínea/estadística & datos numéricos , Estudios de Cohortes , Neoplasias Colorrectales/sangre , Neoplasias Colorrectales/cirugía , Suplementos Dietéticos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/prevención & control , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
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 .