The aim of the study is to examine the effects of anemia correction with intravenous administered iron on clinical outcomes and the immune response on the tumor in patients with planned colonic- or rectal cancer surgery. The study will be performed as a retrospective propensity score-matched cohort study with an examination of immune response in tumor and clinical outcomes, between patients with anemia without correction with iron(III)isomaltoside, non-anemic patients, and anemic patients treated with iron(III)isomaltoside prior to surgery. Propensity score matching will ensure identification of controls from a pool of patients treated at the Department of Surgery, Zealand University Hospital. The two control groups will be: an anemic historical control group (group 1), and a non-anemic concurrent control group (group 2). Group 3 will be the treatment group, with patients with anemia and treated with iron(III)isomaltoside. The study period of cases undergoing i.v. treatment will be 1st of February 2017 to 31st of October 2019 with approximately 70 cases included
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
200
Individual weight and hemoglobin dependent dosage
Gene expression and lymphocyte infiltration of the tumor
770 gene expression analysis and CD3/CD8+ lymphocyte infiltration of the primary tumor
Time frame: 1 day after surgery
Complications
Postoperative complications after surgery measured by the Clavien-Dindo classification
Time frame: 30 days after surgery
Length of stay
Length of postoperative hospital stay, until discharge or death.
Time frame: up to 100 days
Readmission
Any readmission over 24 hours in length
Time frame: Within 30 days after surgery
Time to chemotherapy
Tme from surgery to adjuvant oncological treatment for patients with high risk stage II and stage III disease
Time frame: up to 100 days
Perioperative blood transfusions
Any blood transfusions measured in ml.
Time frame: from outpatient assesment to 30 days after surgery
Mortality
Mortality
Time frame: 30 days, 90 days and one year
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