Iron DeficienciesID-COLONCT06276140
Iron-deficiency Anaemia and Its Impact on Recovery After Colorectal Cancer Surgery
An observational study of Iron Deficiencies and Iron Deficiency Anaemia, run by Oncology Institute of Vojvodina at 1 site in Serbia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiencies, Iron Deficiency Anaemia, Postoperative Complications
- What is being tested?
- Laboratory analyses for the detection of iron deficiency anaemia
- How many people
- 200 participants
- Where
- 1 siteSerbia
- Study dates
- 3 Jun 2024to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients undergoing elective surgical treatment of colorectal cancer.
Who may be able to join
- Adult patients (˃ 18 years of age)
- ASA III clinical status
- Patients undergoing radical surgical treatment of colorectal cancer
- Signed written informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.
Read the 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]
- Conditions
- Iron Deficiencies, Iron Deficiency Anaemia, Postoperative Complications, Colorectal Cancer
- Being tested
- Laboratory analyses for the detection of iron deficiency anaemia
- Medical subject headings
- Iron Deficiencies, Anemia, Iron-Deficiency, Postoperative Complications, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory analyses for the detection of iron deficiency anaemiaDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Iron deficiency anaemia | Defined as: decreased serum iron concentration and TSAT, increased TIBC, UIBC, as well as decreased haemoglobin concentration (HGB) Receives: 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 Receives: Diagnostic Test: Laboratory analyses for the detection of iron deficiency anaemia | |
| Control group | Defined as: normal serum iron concentration, TSAT, TIBC, UIBC and HGB Receives: Diagnostic Test: Laboratory analyses for the detection of iron deficiency anaemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall morbidity
score of Comprehensive Complication Index (CCI)
Measured: during hospital-stay
Secondary outcomes (13)
Prevalence of absolute iron deficiency, functional iron deficiency and iron deficiency anaemia in the study population
number of patients; proportion
Measured: at inclusion
Red blood cell transfusion rate
number of cases; proportion
Measured: during hospital-stay
All-cause infection rate
number of cases; proportion
Measured: during hospital-stay
Days of antibiotic use
number of days
Measured: during hospital-stay
Number of different antibiotics administered
number of antibiotics
Measured: during hospital-stay
Length of Intensive care unit-stay
number of days
Measured: during hospital-stay
Length of hospital-stay
number of days
Measured: during hospital-stay
Intraoperative complications
grade of ClassIntra classification of intraoperative adverse events
Measured: during anaesthesia and surgical intervention
Quality of postoperative recovery
score achieved on QoR-15 scale
Measured: on the first, second and fifth postoperative day
Reoperation
number of cases; proportion
Measured: during hospital-stay
Estimated total iron-deficit
in mg, using the Ganzoni equation
Measured: one day prior to surgery
Serum ferritin level
in ng/mL
Measured: one day prior to surgery
Values of different erythrocyte indices
calculated based on the complete blood count parameters
Measured: one day prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start3 Jun 2024
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Iron DeficienciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncology Institute of Vojvodina
- Sponsor type
- Other government
- Collaborators
- University of Bern
- Responsible party
- Principal investigator, Nora Mihalek, Oncology Institute of Vojvodina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276140
- Sponsor's protocol ID
- 4/23/2-4661/2-9
- Acronym
- ID-COLO
- Status last verified
- May 2025
- First submitted
- 18 Feb 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23728278Krielen 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.
PubMed 34171869Stark 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.
PubMed 23411725Al-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.
PubMed 33762368Cappellini 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.
PubMed 31665543
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06276140
- Acronym / sponsor ID
- ID-COLO / 4/23/2-4661/2-9
- Conditions
- Iron Deficiencies, Iron Deficiency Anaemia, Postoperative Complications, Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Oncology Institute of VojvodinaOther government
- Collaborators
- University of Bern
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Iron deficiency anaemia | – | Diagnostic Test: Laboratory analyses for the detection of iron deficiency anaemiaDefined as: decreased serum iron concentration and TSAT, increased TIBC, UIBC, as well as decreased haemoglobin concentration (HGB) |
| Iron deficiency in the latent phase | – | Diagnostic Test: Laboratory analyses for the detection of iron deficiency anaemiaDefined as: decreased serum iron concentration and TSAT, increased TIBC, UIBC, as well as normal HGB |
| Control group | – | Diagnostic Test: Laboratory analyses for the detection of iron deficiency anaemiaDefined as: normal serum iron concentration, TSAT, TIBC, UIBC and HGB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing elective surgical treatment of colorectal cancer.
Key inclusion criteria (4 listed)
- Adult patients (˃ 18 years of age)
- ASA III clinical status
- Patients undergoing radical surgical treatment of colorectal cancer
- Signed written informed consent
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory analyses for the detection of iron deficiency anaemiaErythrocyte 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. | Diagnostic test | Control group, Iron deficiency anaemia, Iron deficiency in the latent phase |
Primary outcome
Overall morbidity
Time frame: during hospital-stay
score of Comprehensive Complication Index (CCI)
13 secondary outcomes
Prevalence of absolute iron deficiency, functional iron deficiency and iron deficiency anaemia in the study population
Time frame: at inclusion
Red blood cell transfusion rate
Time frame: during hospital-stay
All-cause infection rate
Time frame: during hospital-stay
Days of antibiotic use
Time frame: during hospital-stay
Number of different antibiotics administered
Time frame: during hospital-stay
Length of Intensive care unit-stay
Time frame: during hospital-stay
Length of hospital-stay
Time frame: during hospital-stay
Intraoperative complications
Time frame: during anaesthesia and surgical intervention
Quality of postoperative recovery
Time frame: on the first, second and fifth postoperative day
Reoperation
Time frame: during hospital-stay
Estimated total iron-deficit
Time frame: one day prior to surgery
Serum ferritin level
Time frame: one day prior to surgery
Values of different erythrocyte indices
Time frame: one day prior to surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Background: PubMed 23728278Slankamenac 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.
- Background: PubMed 34171869Krielen 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.
- Background: PubMed 23411725Stark 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.
- Background: PubMed 33762368Al-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.
- Background: PubMed 31665543Cappellini 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiencies and Iron Deficiency Anaemia, run by Oncology Institute of Vojvodina at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall morbidity (time frame: during hospital-stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06276140, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.