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| Name | Class |
|---|---|
| University of Bern | OTHER |
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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:
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.
The following erythrocyte indices based on the preoperative complete blood count results will be calculated for each patient one day prior to surgical treatment:
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]
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron deficiency anaemia | Defined as: decreased serum iron concentration and TSAT, increased TIBC, UIBC, as well as decreased haemoglobin concentration (HGB) |
| |
| Iron deficiency in the latent phase | Defined as: decreased serum iron concentration and TSAT, increased TIBC, UIBC, as well as normal HGB |
| |
| Control group | Defined as: normal serum iron concentration, TSAT, TIBC, UIBC and HGB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall morbidity | score of Comprehensive Complication Index (CCI) | during hospital-stay |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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Consecutive patients undergoing elective surgical treatment of colorectal cancer.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Institute of Vojvodina | Kamenitz | 21204 | Serbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23728278 | Background | 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. | |
| 34171869 | 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. |
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Blood samples for laboratory analyses
|
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 |
| 23411725 | 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. |
| 33762368 | 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. |
| 31665543 | 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. |
| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| D018798 | Anemia, Iron-Deficiency |
| D011183 | Postoperative Complications |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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