Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06276140
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-18
Brief Title:
Iron-deficiency Anaemia and Its Impact on Recovery After Colorectal Cancer Surgery
Sponsor:
Oncology Institute of Vojvodina
Organization:
Oncology Institute of Vojvodina
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ID-COLO
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
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 - 34
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 gL - actual hemoglobin gL x 24 iron depot mg
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 - 34
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 gL - actual hemoglobin gL x 24 iron depot mg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None