Randomized, Parallel Group, Clinical Trial Comparing Intravenous Iron Sucrose Versus Oral Ferrous Sulphate in the Treatment of Perioperative Iron Deficiency in Patients With Colo-Rectal Neoplasm and Iron Deficiency Anemia.
Most patients with colorectal neoplasm have iron deficiency, which can be triggered in the
pre-operative period by a decrease of iron intake and the bleeding in the site of neoplasm.
In the postoperative period, iron deficiency can be aggravated by surgical bleeding.
Iron plays a leading rol in haemoglobin production, cell mitosis and immune system. Animal
experimentation has shown that induced iron deficiency and mild anemia lead to postoperative
mortality and lactacidemia in a model of peritonitis.
Moreover, anemia is the main risk factor to require intra and postoperative blood
transfusions, and iron deficiency and anemia are associated to a larger number of
postoperative complications (infections and longer hospital stay).
Oral iron therapy is the standard treatment in patients with preoperative iron deficiency,
but iron levels inside red cells may not reach normality in time before surgery, and it can
not be resumed until the patient can start again oral feeding.
In these patients, any increase in preoperative haemoglobin decreases the risk to need a
blood transfusion during or after surgery.
This trial will compare standard oral iron and intravenous iron.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Preoperative variations in hemoglobin.
Pere Poch Martí, MD
Fundació Hospital-Asil de Granollers (Barcelona, Spain)
Spain: Spanish Agency of Medicines