Multicenter randomized controlled trial comparing intravenous iron infusion with oral iron suppletion in the preoperative work-up of patients with anemia that undergo surgery for cancer in the bowel.

• Conditions: Patients with anemia that undergo curative surgery in case of a colorectal carcinoma; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-002827-87-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-09
• Last Update Posted: 24 November 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Colorectal carcinoma
-Laparoscopic or open segment resection or a low anterior resection
-Iron deficiency anemia: Hb <7,5mmol/l (12 g/dl) for women and Hb <8 mmol/l (13 g/dl) for men en TSAT<20%
-Age 18 years or older
-Written informed consent for study participation

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 128

Exclusion Criteria

-Palliative surgery / metastasized disease
-Received blood transfusion within one month before screening
-Serum ferritin = 800 µg/L
-Pregnancy
-Preoperative chemoradiation (Short 5x5gy = no exclusion)
-Contraindication for the use of Ferric(III)carboxymaltose or ferrofumarate
-ASA classification > 3
-Use of erythropoietin stimulating agents within three months before screening
-Chronic kidney disease (GFR < 30ml/min/m)
-Myelodysplastic syndrome
-Severe anemia with indication for blood transfusion
-Hereditary Heamochromatosis
-Thalassemia
-Hemolytic anemia/ chronic hemolysis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim is to determine the efficiency of preoperative intravenous iron suppletion in comparison with the standard peri-operative oral substitution in anemic patients with colorectal cancer.;Secondary Objective: Secondary aims of the trial:<br>- To analyze the effect of preoperative intravenous iron therapy on postoperative morbidity, length of stay, quality of life and fatigue<br>- To analyze the effect of preoperative intravenous iron therapy on amount of blood transfusions needed.<br>- To determine the cost effectiveness of preoperative iron substitution in comparison with oral substitution.<br>;Primary end point(s): - Percentage of patients with normalization of HB-level from start treatment to day of surgery. <br> (HB > 12g/dl (7.5mmol/L) for women and HB >13 g/dl (8.0mmol/L) for men;Timepoint(s) of evaluation of this end point: At day prior to surgery or day of surgery<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Change in morbidity score (Clavien-Dindo classification).<br>- Total change from baseline HB-level at preoperation and postoperative day 1, at 1,4,8, and 12 weeks<br>- Change in baseline in other iron/hematological parameters (i.e. TSAT, ferritin, CRP) at pre-operation, at day 1 and at 1, 4, 8 and 12 weeks post-operative.<br>- Change from baseline in health-related QoL<br>- Change from baseline in fatigue scores <br>- Amount of blood transfusions needed;Timepoint(s) of evaluation of this end point: Secondary endpoints will be evaluated at postoperative day 1 at and at 1, 4, 8, 12, and 36 weeks posteroperative.