The main objective of this study is to evaluate the efficacy of intravenous iron sucrose in increasing preoperative haemoglobin values in patients with colo-rectal neoplasm and iron deficiency anemia, compared to the standard treatment with oral iron. It will also determine whether intravenous iron sucrose administration improves outcomes such as postoperative haemoglobin values, serum ferritin values, transfusional needs, postoperative complications, or length of hospital stay.

Condition	Intervention	Phase
Colorectal Neoplasm Iron deficiency anemia	Drug: i.v. iron sucrose  Drug: Oral iron	Phase IV

Further Study Details: 

Primary Outcomes: Preoperative variations in hemoglobin.
Secondary Outcomes: Postoperative variations in hemoglobin.; Blood transfusion needs (pre, intra and postoperative); Postoperative complications:; - Pulmonary thromboembolism; - Infections; - Reintervention; - Death; Length of hospital stay
Expected Total Enrollment:  150

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Non-recurrent colorectal neoplasm, surgically resectable
• Anemia

Exclusion Criteria:

• Severe renal impairment
• High anesthetic risk

Please refer to this study by ClinicalTrials.gov identifier  NCT00199277

Spain
      Hospital Miguel Servet, Zaragoza,  Spain
Spain, Barcelona
      Hospital Universitari Germans Trias i Pujol, Badalona,  Barcelona,  Spain
      Hospital Comarcal Sant Jaume de Calella., Calella,  Barcelona,  Spain
      Fundació Hospital Asil de Granollers, Granollers,  Barcelona,  Spain
      Consorci Sanitari del Maresme, Mataró,  Barcelona,  Spain

Study chairs or principal investigators

Pere Poch Martí, MD,  Study Chair,  Fundació Hospital-Asil de Granollers (Barcelona, Spain)   

Study ID Numbers:  DM01VEN/4/03
Last Updated:  September 19, 2005
Record first received:  September 16, 2005
ClinicalTrials.gov Identifier:  NCT00199277
Health Authority: Spain: Spanish Agency of Medicines
ClinicalTrials.gov processed this record on 2005-09-20