Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.
- Conditions
- Colorectal CancerAnemiaIron-deficiency
- Interventions
- Drug: Iron(III)isomaltoside
- Registration Number
- NCT05221957
- Lead Sponsor
- Zealand University Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Undergoing curative intended surgery for colon or rectum cancer
- UICC stage I-III
- Neoadjuvant oncological treatment
- Acute / subacute surgery
- Palliative surgery
- Other pathology than adenocarcinoma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iron(III)isomaltoside 1000 Iron(III)isomaltoside Anemic patients receiving treatment with iron(III)isomaltoside
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Length of stay up to 100 days Length of postoperative hospital stay, until discharge or death.
Readmission Within 30 days after surgery Any readmission over 24 hours in length
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
Perioperative blood transfusions from outpatient assesment to 30 days after surgery Any blood transfusions measured in ml.
Mortality 30 days, 90 days and one year Mortality