Neutrophil to Lymphocyte Ratio as a Predictor of Complicated Acute Diverticulitis

December 6, 2020 updated by: Palacios Huatuco, Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba

Neutrophil to Lymphocyte Ratio as a Predictor of Complicated Acute Diverticulitis: A Retrospective Cohort Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction Acute diverticulitis (AD) is present in 10-25% of patients with diverticular disease, being most common in sigmoid colon, with around 200.000 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 and/or 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 mg/l. 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 Fisher's tests were used to compare categorical variables among patients with simple acute diverticulitis (sAD) and cAD. A value of p<0.05 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 Type

Observational

Enrollment (Actual)

325

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Córdoba, Argentina, 5000
        • Clinica Universitaria Reina Fabiola

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

325 patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic variables
Time Frame: 2013-2018
sex and age
2013-2018
inpatient stay
Time Frame: 2013-2018
days
2013-2018
level of severity in diverticular process
Time Frame: 2013-2018
confirmed by computed tomography
2013-2018
value of C-reactive protein
Time Frame: 2013-2018
normal value under 5 mg/l
2013-2018
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)
2013-2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

November 30, 2020

First Submitted That Met QC Criteria

December 6, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

December 11, 2020

Last Update Submitted That Met QC Criteria

December 6, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0717040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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