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

Colorectal Cancer Clinical Trial

— ID-COLO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06276140
• Other study ID #: 4/23/2-4661/2-9
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: January 2026

Study information

• Verified date: February 2024
• Source: Oncology Institute of Vojvodina
• Contact: Nora Mihalek, MD
• Phone: +381 62 343 159
• Email: noramihalek[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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]

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Colorectal Cancer
• Colorectal Neoplasms
• Deficiency Diseases
• Iron Deficiency Anaemia
• Postoperative Complications

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oncology Institute of Vojvodina	University of Bern

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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