Oncology Institute of Vojvodina
Kamenitz, 21204, Serbia
NCT Number: NCT06276140
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Kamenitz, 21204, Serbia
The following erythrocyte indices based on the preoperative complete blood count results will be calculated for each patient one day prior to surgical treatment:
The Ganzoni equation for calculating total iron deficit will be calculated for each patient one day prior to surgical treatment, using the following formula:
total iron deficit [mg] = body weight [kg] x (target hemoglobin [g/L] - actual hemoglobin [g/L]) x 2.4 + iron depot [mg]
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Erythrocyte indices based on the preoperative complete blood count results will be calculated for each patient one day prior to surgical treatment.
Overall morbidity of each patient during hospital stay will be scored using the Comprehensive Complication Index (CCI). Intraoperative complications will be graded according to the ClassIntra classification of intraoperative adverse events. The quality of postoperative recovery of each observed patient will be scored on the first, second and fifth postoperative day, using the 15-item quality of recovery scale (QoR-15).
Data about red blood cell transfusion rate, all-cause infection rate, number of days when antibiotics were administered and the number of different antibiotics administered during hospital-stay will be collected.
Time frame: during hospital-stay
score of Comprehensive Complication Index (CCI)
Time frame: at inclusion
number of patients; proportion
Time frame: during hospital-stay
number of cases; proportion
Time frame: during hospital-stay
number of cases; proportion
Time frame: during hospital-stay
number of days
Time frame: during hospital-stay
number of antibiotics
Time frame: during hospital-stay
number of days
Time frame: during hospital-stay
number of days
Time frame: during anaesthesia and surgical intervention
grade of ClassIntra classification of intraoperative adverse events
Time frame: on the first, second and fifth postoperative day
score achieved on QoR-15 scale
Time frame: during hospital-stay
number of cases; proportion
Time frame: one day prior to surgery
in mg, using the Ganzoni equation
Time frame: one day prior to surgery
in ng/mL
Time frame: one day prior to surgery
calculated based on the complete blood count parameters
Oncology Institute of Vojvodina
Other Gov
Preoperative Evaluation and Impact of Iron Deficiency Anaemia on the Incidence of Perioperative Complications and Quality of Recovery After Radical Colorectal Cancer Surgery
Acronym: ID-COLO
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