NCT06276140Enrolling by invitation
Iron-deficiency Anaemia and Its Impact on Recovery After Colorectal Cancer Surgery
Preoperative Evaluation and Impact of Iron Deficiency Anaemia on the Incidence of Perioperative Complications and Quality of Recovery After Radical Colorectal Cancer Surgery
Source: ClinicalTrials.gov · Last updated 4 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The aim of this prospective, observational cohort study is to assess the impact of iron deficiency anaemia on the incidence of perioperative complications and the quality of recovery after surgery in patients undergoing colorectal cancer surgery. The main questions the study aims to answer are: * whether the presence of preoperative iron deficiency anaemia leads to a poorer quality of postoperative recovery in patients undergoing colorectal cancer surgery * whether different combinations of complete blood count parameters (red blood cell indices) could be suitable diagnostic tools for the detection of iron deficiency in the latent stage (without laboratory-confirmed anaemia) in colorectal cancer patients. Blood samples for laboratory analyses will be collected from each study patient admitted to the surgical ward one day prior to elective surgery and on the first postoperative day during the stay in the intensive care unit. The pre-operative laboratory analyses include a complete blood count and serum iron status parameters (iron concentration, ferritin concentration, TIBC, UIBC and TSAT). Laboratory parameters analysed on the first postoperative day include complete blood count, serum concentration of electrolytes (Na, K, Ca, Cl, Mg), serum concentration of urea and creatinine, parameters of haemostasis (aPTT, PT, INR), serum concentration of C-reactive protein and procalcitonin. Data about overall morbidity, intraoperative complications, quality of postoperative recovery, red blood cell transfusion rate, all-cause infection rate, antibiotic usage, as well as length of hospital stay will be collected. The researchers will compare the group of patients with iron deficiency anaemia, the group of patients with iron deficiency in the latent stage and the control group to determine whether patients with iron deficiency have a higher incidence of perioperative complications and impaired recovery after surgery. The researchers will investigate whether iron deficiency can be detected at an early stage, when anaemia is not yet present, by calculating various red blood cell indices.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 18 Feb 2024
- Start date
- 3 Jun 2024
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Oncology Institute of Vojvodina
- Diseases
- Colorectal cancer
- NCT number
- NCT06276140
What you commit to
- Study type: Observational
- Planned participants: 200
- From 3 Jun 2024 to the primary completion date, 31 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of red blood cell transfusion in the period of 120 days prior to hospital-admission
Other illness
- Patients undergoing palliative surgical treatment of colorectal cancer
Lab values
- Anaemic patients without iron deficiency, defined as: normal serum iron concentration, TSAT, TIBC, UIBC, and decreased HGB, HCT and RBC
- Stage III, IV, or V of chronic kidney disease (creatinine clearance \< 60 mL/min)
- Significant intraoperative bleeding, which requires transfusion of red blood cell products, calculated using the Gross-formula:
- allowable blood loss \[mL\] = (estimated blood volume \[mL\] x (initial HGB \[g/L\] - HGB level when transfusion is required \[g/L\])) / average of initial HGB and HGB level when transfusion is required \[g/L\] The cut-off value for HGB level when transfusion is required is set to 80 g/L.
Other
- Presence of other type of anaemia than iron deficiency anaemia (e.g. alpha- or beta-thalassemia, sickle-cell anaemia, etc.)
Who the study is looking for
- Adult patients (˃ 18 years of age)
- ASA III clinical status
- Patients undergoing radical surgical treatment of colorectal cancer
- Signed written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oncology Institute of Vojvodina Coordinator of this site? Confirm its status | Kamenitz | Serbia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.