Iron-deficiency Anaemia and Its Impact on Recovery After Colorectal Cancer Surgery

Trial Title: Iron-deficiency Anaemia and Its Impact on Recovery After Colorectal Cancer Surgery

NCT ID: NCT06276140

Condition: Iron Deficiencies
Iron Deficiency Anaemia
Postoperative Complications
Colorectal Cancer

Conditions: Official terms:
Colorectal Neoplasms
Anemia
Anemia, Iron-Deficiency
Iron Deficiencies
Deficiency Diseases
Postoperative Complications

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Laboratory analyses for the detection of iron deficiency anaemia
Description: 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.
Arm group label: Control group
Arm group label: Iron deficiency anaemia
Arm group label: Iron deficiency in the latent phase

Summary: 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.

Detailed description: The following erythrocyte indices based on the preoperative complete blood count results will be calculated for each patient one day prior to surgical treatment: - Mentzer index: MCV / RBC - Green and King index: MCV2 x RDW / (100 x HGB) - RDW index: MCV x RDW / RBC - Shine and Lal index: MCV2 x MCH / 100 - England and Fraser index: MCV - RBC - (5 x HGB) - 3.4 - Srivastava index: MCH / RBC - Ricerca index: RDW / RBC - Ehsani index: MCV - (10 x RBC) - Sirdah index: MCV - RBC - (3 x HGB) - Sehgal index: MCV2 / RBC 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]

Criteria for eligibility:

Study pop:
Consecutive patients undergoing elective surgical treatment of colorectal cancer.

Sampling method: Probability Sample
Criteria:
Inclusion Criteria: - Adult patients (˃ 18 years of age) - ASA III clinical status - Patients undergoing radical surgical treatment of colorectal cancer - Signed written informed consent Exclusion Criteria: - Patients undergoing palliative surgical treatment of colorectal cancer - Anaemic patients without iron deficiency, defined as: normal serum iron concentration, TSAT, TIBC, UIBC, and decreased HGB, HCT and RBC - Presence of other type of anaemia than iron deficiency anaemia (e.g. alpha- or beta-thalassemia, sickle-cell anaemia, etc.) - History of red blood cell transfusion in the period of 120 days prior to hospital-admission - 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: April 2024

Completion date: January 2026

Lead sponsor:
Agency: Oncology Institute of Vojvodina
Agency class: Other

Collaborator:
Agency: University of Bern
Agency class: Other

Source: Oncology Institute of Vojvodina

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06276140