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NCT Number: NCT06276140

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

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.

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Key information

About this study

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]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laboratory analyses for the detection of iron deficiency anaemia

Diagnostic Test

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.

Primary outcomes

  1. Overall morbidity

    Time frame: during hospital-stay

    score of Comprehensive Complication Index (CCI)

Secondary outcomes

  1. Prevalence of absolute iron deficiency, functional iron deficiency and iron deficiency anaemia in the study population

    Time frame: at inclusion

    number of patients; proportion

  2. Red blood cell transfusion rate

    Time frame: during hospital-stay

    number of cases; proportion

  3. All-cause infection rate

    Time frame: during hospital-stay

    number of cases; proportion

  4. Days of antibiotic use

    Time frame: during hospital-stay

    number of days

  5. Number of different antibiotics administered

    Time frame: during hospital-stay

    number of antibiotics

  6. Length of Intensive care unit-stay

    Time frame: during hospital-stay

    number of days

  7. Length of hospital-stay

    Time frame: during hospital-stay

    number of days

  8. Intraoperative complications

    Time frame: during anaesthesia and surgical intervention

    grade of ClassIntra classification of intraoperative adverse events

  9. Quality of postoperative recovery

    Time frame: on the first, second and fifth postoperative day

    score achieved on QoR-15 scale

  10. Reoperation

    Time frame: during hospital-stay

    number of cases; proportion

  11. Estimated total iron-deficit

    Time frame: one day prior to surgery

    in mg, using the Ganzoni equation

  12. Serum ferritin level

    Time frame: one day prior to surgery

    in ng/mL

  13. Values of different erythrocyte indices

    Time frame: one day prior to surgery

    calculated based on the complete blood count parameters

Sponsors and collaborators

Lead sponsor

Oncology Institute of Vojvodina

Other Gov

Collaborators

  • University of Bern

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2024
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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