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

NCT06276140 | Enrolling By Invitation

• 1 other identifier: 4/23/2-4661/2-9
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Iron Deficiencies; Iron Deficiency Anaemia; Postoperative Complications; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall morbidity

  score of Comprehensive Complication Index (CCI)

  during hospital-stay

Secondary Outcomes (13)

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

  at inclusion

• Red blood cell transfusion rate

  during hospital-stay

• All-cause infection rate

  during hospital-stay

• Days of antibiotic use

  during hospital-stay

• Number of different antibiotics administered

  during hospital-stay

Study Arms (3)

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

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

Control group

Defined as: normal serum iron concentration, TSAT, TIBC, UIBC and HGB

Diagnostic Test: Laboratory analyses for the detection of iron deficiency anaemia

Interventions

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.

Control group; Iron deficiency anaemia; Iron deficiency in the latent phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients undergoing elective surgical treatment of colorectal cancer.

You may qualify if:

• Adult patients (˃ 18 years of age)
• ASA III clinical status
• Patients undergoing radical surgical treatment of colorectal cancer
• Signed written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oncology Institute of Vojvodina: lead
• University of Bern: collaborator

Study Sites (1)

Oncology Institute of Vojvodina

Kamenitz, 21204, Serbia

Location

Related Publications (5)

• 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.

  PMID: 23728278 BACKGROUND

• 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.

  PMID: 34171869 BACKGROUND

• 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.

  PMID: 23411725 BACKGROUND

• 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.

  PMID: 33762368 BACKGROUND

• 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.

  PMID: 31665543 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for laboratory analyses

MeSH Terms

Conditions

Iron Deficiencies; Anemia, Iron-Deficiency; Postoperative Complications; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: February 23, 2024
• Study Start: June 3, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)