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

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.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00199277
Enrollment
150
Registered
2005-09-20
Start date
Unknown
Completion date
Unknown
Last updated
2005-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasm, Iron Deficiency Anemia

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.

Interventions

DRUGi.v. iron sucrose

Sponsors

J. Uriach and Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Non-recurrent colorectal neoplasm, surgically resectable * Anemia

Exclusion criteria

* Severe renal impairment * High anesthetic risk

Design outcomes

Primary

MeasureTime frame
Preoperative variations in hemoglobin.

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026