Clinical trial NCT00199277: Iron Therapy in Colo-Rectal Neoplasm and Iron Deficiency Anemia: Intravenous Iron Sucrose Versus Oral Ferrous Sulphate.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colorectal Neoplasm
Iron Deficiency Anemia
Lead sponsor: J. Uriach and Company
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Non-recurrent colorectal neoplasm, surgically resectable
* Anemia

Exclusion Criteria:

* Severe renal impairment
* High anesthetic risk

Primary outcomes:
measure: Preoperative variations in hemoglobin.
Secondary outcomes:
measure: Postoperative variations in hemoglobin.
measure: Blood transfusion needs (pre, intra and postoperative)
measure: Postoperative complications:
measure: - Pulmonary thromboembolism
measure: - Infections
measure: - Reintervention
measure: - Death
measure: Length of hospital stay
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Calella
country: Spain
facility: Hospital Comarcal Sant Jaume de Calella.
state: Barcelona
city: Granollers
country: Spain
facility: Fundació Hospital Asil de Granollers
state: Barcelona
city: Mataró
country: Spain
facility: Consorci Sanitari del Maresme
state: Barcelona
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Fundació Hospital-Asil de Granollers (Barcelona, Spain)
name: Pere Poch Martí, MD
role: STUDY_CHAIR
References: