Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04663490
Status:
COMPLETED
Last Update Posted:
2020-12-11
First Post:
2020-11-30
Brief Title:
Neutrophil to Lymphocyte Ratio as a Predictor of Complicated Acute Diverticulitis
Sponsor:
Clinica Universitaria Reina Fabiola Universidad Catolica de Cordoba
Organization:
Clinica Universitaria Reina Fabiola Universidad Catolica de Cordoba
Study Overview
Official Title:
Neutrophil to Lymphocyte Ratio as a Predictor of Complicated Acute Diverticulitis A Retrospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2020-12
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:
None
Brief Summary:
Introduction Various biomarkers have been studied to predict the severity of acute diverticulitis AD such as the leukocyte count and CRP which are useful but lack sufficient sensitivity The neutrophil-lymphocyte ratio NLR has been identified as a new inflammatory biomarker in several abdominal pathologies However few studies determine its association with the severity of AD The objective of the present study was to determine the utility and diagnostic precision of NLR in complicated acute diverticulitis cAD
Material and methods Descriptive retrospective and analytical study Patients older than 18 years with a diagnosis of AD were included from 2013 - 2018 Demographic variables days of hospitalization leukocyte count neutrophils lymphocytes ESR CRP and NLR were analyzed The sensitivity and specificity for the diagnosis of cAD were determined using ROC curves
Material and methods Descriptive retrospective and analytical study Patients older than 18 years with a diagnosis of AD were included from 2013 - 2018 Demographic variables days of hospitalization leukocyte count neutrophils lymphocytes ESR CRP and NLR were analyzed The sensitivity and specificity for the diagnosis of cAD were determined using ROC curves
Detailed Description:
Introduction Acute diverticulitis AD is present in 10-25 of patients with diverticular disease being most common in sigmoid colon with around 200000 hospitalizations yearly As much as one fifth of patients are younger than 50 at the moment of diagnosis and around 5 under the age of 40
Confirming the diagnosis requires the utilization of imaging studies therefore American Society of Colon and Rectal Surgeons ASCRS established that computed tomography CT is the standard method for the diagnosis of AD with a sensitivity of 98 and a specificity of 99 The tomographic findings vary according the severity of diverticular disease which is categorized through a modified Hinchey classification system Approximately 10-15 of AD patients may develop complications that imply the onset of abscesses fistulas stenosis obstruction andor perforation
Recently interest has been raised in the role of biomarkers in diverticular disease as non-invasive reliable inexpensive tools that may help in the early diagnosis of complicated AD such as C-reactive protein CRP useful marker in the prediction of the level of inflammation and severity of AD
In 2001 identified the neutrophil-lymphocyte ratio NLR as an inflammation marker in critical patients defining as the absolute neutrophil count divided by the absolute lymphocyte count Over the last decade NLR effectiveness has been recognized in various pathologies both benign and malignant finding that the levels of neutrophils rise as a part of the inflammatory cascade whereas lymphocytes diminish during sepsis making a novel subclinical biomarker with a prognostic value in oncological cardiovascular and infectious diseases among others The NLR may be obtained from the blood count data which represents a lower cost regarding other known biomarkers It was also demonstrated that high values of NLR are associated with severe abdominal infections and worse outcomes reason why it started to be applied as a predictor to evaluate results in surgical patients
Currently the debate on usefulness of NLR as a predictor of complications in AD remains open specially the relation to the severity of the disease the clinical impact and the necessity of minimally invasive or emergency surgical procedures
On the other hand its diagnostic efficacy has not been studied even in our field Up until now there are only four studies published in Ireland Israel and South Korea The purpose of the study was to determine the usefulness and diagnostic accuracy of NLR in complicated acute diverticulitis cAD
Material and methods Study population A descriptive retrospective cohort and analytical study was undertaken Medical histories and an electronic database from General Surgery Service were reviewed All the patients over the age of 18 with AD diagnosis through CT were included since January 2013 until January 2018 in a University Hospital of Cordoba Argentina with third level reference
Patients were excluded if they had chronic diseases susceptible to modify the immune inflammatory response extra-abdominal infections immunosuppression and neoplasias and those who supplied incomplete data in their electronic clinical histories
Study of variables Demographic variables sex and age days of inpatient stay level of severity in diverticular process objectified by CT were analyzed It was recorded the value of serum leukocyte neutrophil and lymphocyte concentration Erythrocyte Sedimentation Rate ESR CRP and NLR at the moment of consultation on call
Variable definition NLR It can be obtained from the blood count the absolute neutrophil count divided by the absolute lymphocyte count CRP normal value under 5 mgl Statistical analysis The categorical variables were expressed as frequency percentage the continuous variables as mean value standard deviation SD or median range according to the distribution of data Mann Whitney test was used to compare the continuous variables Chi-square and Fishers tests were used to compare categorical variables among patients with simple acute diverticulitis sAD and cAD A value of p005 was considered as statistically significant
ROC Receiver Operating Characteristic curves were used as diagnostic tests to evaluate the diagnostic accuracy of NLR as predictor of complicated AD determining sensitivity Se specificity Sp positive predictive value PPV and negative predictive value NPV Youden index was used to find the cut-off point with the best diagnostic yield for NLR in cAD SPSS 26 software and GraphPad 7 software were used for statistical analysis
Confirming the diagnosis requires the utilization of imaging studies therefore American Society of Colon and Rectal Surgeons ASCRS established that computed tomography CT is the standard method for the diagnosis of AD with a sensitivity of 98 and a specificity of 99 The tomographic findings vary according the severity of diverticular disease which is categorized through a modified Hinchey classification system Approximately 10-15 of AD patients may develop complications that imply the onset of abscesses fistulas stenosis obstruction andor perforation
Recently interest has been raised in the role of biomarkers in diverticular disease as non-invasive reliable inexpensive tools that may help in the early diagnosis of complicated AD such as C-reactive protein CRP useful marker in the prediction of the level of inflammation and severity of AD
In 2001 identified the neutrophil-lymphocyte ratio NLR as an inflammation marker in critical patients defining as the absolute neutrophil count divided by the absolute lymphocyte count Over the last decade NLR effectiveness has been recognized in various pathologies both benign and malignant finding that the levels of neutrophils rise as a part of the inflammatory cascade whereas lymphocytes diminish during sepsis making a novel subclinical biomarker with a prognostic value in oncological cardiovascular and infectious diseases among others The NLR may be obtained from the blood count data which represents a lower cost regarding other known biomarkers It was also demonstrated that high values of NLR are associated with severe abdominal infections and worse outcomes reason why it started to be applied as a predictor to evaluate results in surgical patients
Currently the debate on usefulness of NLR as a predictor of complications in AD remains open specially the relation to the severity of the disease the clinical impact and the necessity of minimally invasive or emergency surgical procedures
On the other hand its diagnostic efficacy has not been studied even in our field Up until now there are only four studies published in Ireland Israel and South Korea The purpose of the study was to determine the usefulness and diagnostic accuracy of NLR in complicated acute diverticulitis cAD
Material and methods Study population A descriptive retrospective cohort and analytical study was undertaken Medical histories and an electronic database from General Surgery Service were reviewed All the patients over the age of 18 with AD diagnosis through CT were included since January 2013 until January 2018 in a University Hospital of Cordoba Argentina with third level reference
Patients were excluded if they had chronic diseases susceptible to modify the immune inflammatory response extra-abdominal infections immunosuppression and neoplasias and those who supplied incomplete data in their electronic clinical histories
Study of variables Demographic variables sex and age days of inpatient stay level of severity in diverticular process objectified by CT were analyzed It was recorded the value of serum leukocyte neutrophil and lymphocyte concentration Erythrocyte Sedimentation Rate ESR CRP and NLR at the moment of consultation on call
Variable definition NLR It can be obtained from the blood count the absolute neutrophil count divided by the absolute lymphocyte count CRP normal value under 5 mgl Statistical analysis The categorical variables were expressed as frequency percentage the continuous variables as mean value standard deviation SD or median range according to the distribution of data Mann Whitney test was used to compare the continuous variables Chi-square and Fishers tests were used to compare categorical variables among patients with simple acute diverticulitis sAD and cAD A value of p005 was considered as statistically significant
ROC Receiver Operating Characteristic curves were used as diagnostic tests to evaluate the diagnostic accuracy of NLR as predictor of complicated AD determining sensitivity Se specificity Sp positive predictive value PPV and negative predictive value NPV Youden index was used to find the cut-off point with the best diagnostic yield for NLR in cAD SPSS 26 software and GraphPad 7 software were used for statistical analysis
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