Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00199277
Recruitment Status : Unknown
Verified September 2005 by J. Uriach and Company.
Recruitment status was:  Not yet recruiting
First Posted : September 20, 2005
Last Update Posted : September 20, 2005
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasm Iron Deficiency Anemia Drug: i.v. iron sucrose Drug: Oral iron Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Preoperative variations in hemoglobin.

Secondary Outcome Measures :
  1. Postoperative variations in hemoglobin.
  2. Blood transfusion needs (pre, intra and postoperative)
  3. Postoperative complications:
  4. - Pulmonary thromboembolism
  5. - Infections
  6. - Reintervention
  7. - Death
  8. Length of hospital stay

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Non-recurrent colorectal neoplasm, surgically resectable
  • Anemia

Exclusion Criteria:

  • Severe renal impairment
  • High anesthetic risk

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00199277

Layout table for location information
Hospital Universitari Germans Trias i Pujol Not yet recruiting
Badalona, Barcelona, Spain
Contact: Marta Piñol Pascual, MD         
Principal Investigator: Marta Piñol Pascual, MD         
Hospital Comarcal Sant Jaume de Calella. Not yet recruiting
Calella, Barcelona, Spain
Contact: Dolors Vela Payán, MD         
Principal Investigator: Dolors Vela Payán, MD         
Fundació Hospital Asil de Granollers Not yet recruiting
Granollers, Barcelona, Spain
Contact: Ramón López Ferré, MD         
Principal Investigator: Ramón López Ferré, MD         
Consorci Sanitari del Maresme Not yet recruiting
Mataró, Barcelona, Spain
Contact: Alba Bosch Llobet, MD         
Principal Investigator: Alba Bosch Llobet, MD         
Hospital Miguel Servet Not yet recruiting
Zaragoza, Spain
Contact: José Antonio García-Erce, MD         
Principal Investigator: José Antonio García-Erce, MD         
Sponsors and Collaborators
J. Uriach and Company
Layout table for investigator information
Study Chair: Pere Poch Martí, MD Fundació Hospital-Asil de Granollers (Barcelona, Spain)

Layout table for additonal information Identifier: NCT00199277     History of Changes
Other Study ID Numbers: DM01VEN/4/03
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: September 20, 2005
Last Verified: September 2005
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Rectal Neoplasms
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Nutrition Disorders
Ferric Oxide, Saccharated
Trace Elements
Growth Substances
Physiological Effects of Drugs