Iron-deficiency Anaemia and Its Impact on Recovery After Colorectal Cancer Surgery (ID-COLO)

Preoperative Evaluation and Impact of Iron Deficiency Anaemia on the Incidence of Perioperative Complications and Quality of Recovery After Radical 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Postoperative Complications; Colorectal Cancer; Iron Deficiency Anaemia; Iron Deficiencies
• Intervention / Treatment: Diagnostic test: Laboratory analyses for the detection of iron deficiency anaemia

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]

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Serbia
  • Sremska Kamenica, Serbia, 21204
    • Oncology Institute of Vojvodina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Consecutive patients undergoing elective surgical treatment of colorectal cancer.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Iron deficiency anaemia; Defined as: decreased serum iron concentration and TSAT, increased TIBC, UIBC, as well as decreased haemoglobin concentration (HGB)	Diagnostic test: Laboratory analyses for the detection of iron deficiency anaemia; 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.
Iron deficiency in the latent phase; Defined as: decreased serum iron concentration and TSAT, increased TIBC, UIBC, as well as normal HGB	Diagnostic test: Laboratory analyses for the detection of iron deficiency anaemia; 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.
Control group; Defined as: normal serum iron concentration, TSAT, TIBC, UIBC and HGB	Diagnostic test: Laboratory analyses for the detection of iron deficiency anaemia; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall morbidity	score of Comprehensive Complication Index (CCI)	during hospital-stay

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of absolute iron deficiency, functional iron deficiency and iron deficiency anaemia in the study population	number of patients; proportion	at inclusion
Red blood cell transfusion rate	number of cases; proportion	during hospital-stay
All-cause infection rate	number of cases; proportion	during hospital-stay
Days of antibiotic use	number of days	during hospital-stay
Number of different antibiotics administered	number of antibiotics	during hospital-stay
Length of Intensive care unit-stay	number of days	during hospital-stay
Length of hospital-stay	number of days	during hospital-stay
Intraoperative complications	grade of ClassIntra classification of intraoperative adverse events	during anaesthesia and surgical intervention
Quality of postoperative recovery	score achieved on QoR-15 scale	on the first, second and fifth postoperative day
Reoperation	number of cases; proportion	during hospital-stay
Estimated total iron-deficit	in mg, using the Ganzoni equation	one day prior to surgery
Serum ferritin level	in ng/mL	one day prior to surgery
Values of different erythrocyte indices	calculated based on the complete blood count parameters	one day prior to surgery

Collaborators and Investigators

• Sponsor: Oncology Institute of Vojvodina
• Collaborators: University of Bern

Publications and helpful links

General Publications

• Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
• Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732.
• Krielen P, Gawria L, Stommel MWJ, Dell-Kuster S, Rosenthal R, Ten Broek RPG, van Goor H. Inter-Rater Agreement of the Classification of Intraoperative Adverse Events (ClassIntra) in Abdominal Surgery. Ann Surg. 2023 Feb 1;277(2):e273-e279. doi: 10.1097/SLA.0000000000005024. Epub 2023 Jan 10.
• Al-Naseem A, Sallam A, Choudhury S, Thachil J. Iron deficiency without anaemia: a diagnosis that matters. Clin Med (Lond). 2021 Mar;21(2):107-113. doi: 10.7861/clinmed.2020-0582.
• Cappellini MD, Musallam KM, Taher AT. Iron deficiency anaemia revisited. J Intern Med. 2020 Feb;287(2):153-170. doi: 10.1111/joim.13004. Epub 2019 Nov 12.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: February 18, 2024
• First Submitted That Met QC Criteria: February 18, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 29, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Neoplasms by Site; Neoplasms; Metabolic Diseases; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Hematologic Diseases; Colonic Diseases; Iron Metabolism Disorders; Anemia, Hypochromic; Malnutrition; Iron Deficiencies; Colorectal Neoplasms; Anemia; Anemia, Iron-Deficiency; Postoperative Complications; Deficiency Diseases
• Other Study ID Numbers: 4/23/2-4661/2-9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No