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

NCT ID: NCT00199277

Last Updated: 2005-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL

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.

Conditions

Colorectal Neoplasm; Iron Deficiency Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

i.v. iron sucrose

Intervention Type: DRUG

Oral iron

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Non-recurrent colorectal neoplasm, surgically resectable
• Anemia

Exclusion Criteria

• Severe renal impairment
• High anesthetic risk

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

J. Uriach and Company

INDUSTRY

Sponsor Role: lead

Principal Investigators

Pere Poch Martí, MD

Role: STUDY_CHAIR

Fundació Hospital-Asil de Granollers (Barcelona, Spain)

Locations

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

Hospital Miguel Servet

Zaragoza, Zaragoza, Spain

Countries

Spain

Facility Contacts

Marta Piñol Pascual, MD

Role: primary

Dolors Vela Payán, MD

Role: primary

Ramón López Ferré, MD

Role: primary

Alba Bosch Llobet, MD

Role: primary

José Antonio García-Erce, MD

Role: primary

Other Identifiers

DM01VEN/4/03

Identifier Type: -

Identifier Source: org_study_id