Iron Therapy in Colo-Rectal Neoplasm and Iron Deficiency Anemia: Intravenous Iron Sucrose Versus Oral Ferrous Sulphate.

Phase 4

• Conditions: Colorectal Neoplasm; Iron Deficiency Anemia

• Registration Number: NCT00199277
• Lead Sponsor: J. Uriach and Company

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2005-09
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Last Update Submitted: 2005-09-16
• Study First Posted: 2005-09-20
• Last Update Posted: 2005-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Non-recurrent colorectal neoplasm, surgically resectable
• Anemia

Exclusion Criteria

• Severe renal impairment
• High anesthetic risk

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Preoperative variations in hemoglobin.

Secondary Outcome Measures

Name	Time	Method
Postoperative variations in hemoglobin.
Blood transfusion needs (pre, intra and postoperative)
Postoperative complications:
- Pulmonary thromboembolism
- Infections
- Reintervention
- Death
Length of hospital stay

Trial Locations

Locations (5)

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Fundació Hospital Asil de Granollers; 🇪🇸 Granollers, Barcelona, Spain

Consorci Sanitari del Maresme; 🇪🇸 Mataró, Barcelona, Spain

Hospital Comarcal Sant Jaume de Calella.; 🇪🇸 Calella, Barcelona, Spain

Hospital Miguel Servet; 🇪🇸 Zaragoza, Spain