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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by J. Uriach and Company.
Recruitment status was:  Not yet recruiting
Information provided by:
J. Uriach and Company Identifier:
First received: September 16, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 NLM:

Further study details as provided by J. Uriach and Company:

Primary Outcome Measures:
  • Preoperative variations in hemoglobin.

Secondary Outcome Measures:
  • Postoperative variations in hemoglobin.
  • Blood transfusion needs (pre, intra and postoperative)
  • Postoperative complications:
  • - Pulmonary thromboembolism
  • - Infections
  • - Reintervention
  • - Death
  • Length of hospital stay

Estimated Enrollment: 150
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00199277

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, Spain
Sponsors and Collaborators
J. Uriach and Company
Study Chair: Pere Poch Martí, MD Fundació Hospital-Asil de Granollers (Barcelona, Spain)
  More Information Identifier: NCT00199277     History of Changes
Other Study ID Numbers: DM01VEN/4/03 
Study First Received: September 16, 2005
Last Updated: September 16, 2005

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Colorectal Neoplasms
Deficiency Diseases
Rectal Neoplasms
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
Ferric Compounds
Trace Elements
Growth Substances
Physiological Effects of Drugs
Hematinics processed this record on February 20, 2017