Anemia, Colorectal Cancer, Iron-deficiency
Conditions
Keywords
Anemia, Iron-deficiency anemia
Brief summary
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
Interventions
Individual weight and hemoglobin dependent dosage
Sponsors
Zealand University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Propensity score matched cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing curative intended surgery for colon or rectum cancer * UICC stage I-III
Exclusion criteria
* Neoadjuvant oncological treatment * Acute / subacute surgery * Palliative surgery * Other pathology than adenocarcinoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gene expression and lymphocyte infiltration of the tumor | 1 day after surgery | 770 gene expression analysis and CD3/CD8+ lymphocyte infiltration of the primary tumor |
| Complications | 30 days after surgery | Postoperative complications after surgery measured by the Clavien-Dindo classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to chemotherapy | up to 100 days | Tme from surgery to adjuvant oncological treatment for patients with high risk stage II and stage III disease |
| Length of stay | up to 100 days | Length of postoperative hospital stay, until discharge or death. |
| Mortality | 30 days, 90 days and one year | Mortality |
| Perioperative blood transfusions | from outpatient assesment to 30 days after surgery | Any blood transfusions measured in ml. |
| Readmission | Within 30 days after surgery | Any readmission over 24 hours in length |
Contacts
Primary ContactRasmus D Bojesen, MD
Outcome results
None listed