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Neutrophil to Lymphocyte Ratio as a Predictor of Complicated Acute Diverticulitis

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ClinicalTrials.gov Identifier: NCT04663490
Recruitment Status : Completed
First Posted : December 11, 2020
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Palacios Huatuco, Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba

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.


Condition or disease Intervention/treatment
Acute Diverticulitis Diagnostic Test: Neutrophil to Lymphocyte Ratio

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Study Type : Observational
Actual Enrollment : 325 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Neutrophil to Lymphocyte Ratio as a Predictor of Complicated Acute Diverticulitis: A Retrospective Cohort Study
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2020

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Group/Cohort Intervention/treatment
simple acute diverticulitis
Ninety-one percent (n=295) were categorized as simple acute diverticulitis
Diagnostic Test: Neutrophil to Lymphocyte Ratio
Zahorec et al. 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

complicated acute diverticulitis
9% (n=30) presented were categorized as complicated acute diverticulitis
Diagnostic Test: Neutrophil to Lymphocyte Ratio
Zahorec et al. 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




Primary Outcome Measures :
  1. Demographic variables [ Time Frame: 2013-2018 ]
    sex and age

  2. inpatient stay [ Time Frame: 2013-2018 ]
    days

  3. level of severity in diverticular process [ Time Frame: 2013-2018 ]
    confirmed by computed tomography

  4. value of C-reactive protein [ Time Frame: 2013-2018 ]
    normal value under 5 mg/l

  5. value of Neutrophil to Lymphocyte Ratio [ Time Frame: 2013-2018 ]
    It can be obtained from the blood count (the absolute neutrophil count divided by the absolute lymphocyte count)



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Ages Eligible for Study:   18 Years to 92 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
325 patients
Criteria

Inclusion Criteria:

  • Patients older than 18 years.
  • Patients with a diagnosis of acute diverticulitis confirmed by computed tomography.

Exclusion Criteria:

  • Patients under 18 years of age.
  • Patients with hematological diseases.
  • Patients with extra abdominal infections.
  • Patients with oncological diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04663490


Locations
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Argentina
Clínica Universitaria Reina Fabiola
Córdoba, Argentina, 5000
Sponsors and Collaborators
Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba
Publications:

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Responsible Party: Palacios Huatuco, General Surgeon, Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba
ClinicalTrials.gov Identifier: NCT04663490    
Other Study ID Numbers: 0717040
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to the sensitive nature of the study, patients were assured that the raw data would remain confidential and would not be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Palacios Huatuco, Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba:
neutrophil-to-lymphocyte ratio
C-reactive protein
biomarkers
Additional relevant MeSH terms:
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Diverticulitis
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases