Neutrophil to Lymphocyte Ratio as a Predictor of Complicated Acute Diverticulitis

Acute Diverticulitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04663490
• Other study ID #: 0717040
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: January 1, 2020

Study information

• Verified date: December 2020
• Source: Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2018
• Gender: All
• Age group: 18 Years to 92 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Diverticulitis
• Diverticulitis

Intervention

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

Locations

Country	Name	City	State
Argentina	Clínica Universitaria Reina Fabiola	Córdoba

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba

Country where clinical trial is conducted

Argentina, 

References & Publications (17)

Agha RA, Borrelli MR, Vella-Baldacchino M, Thavayogan R, Orgill DP; STROCSS Group. The STROCSS statement: Strengthening the Reporting of Cohort Studies in Surgery. Int J Surg. 2017 Oct;46:198-202. doi: 10.1016/j.ijsu.2017.08.586. Epub 2017 Sep 7. — View Citation

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Hogan J, Sehgal R, Murphy D, O'Leary P, Coffey JC. Do Inflammatory Indices Play a Role in Distinguishing between Uncomplicated and Complicated Diverticulitis? Dig Surg. 2017;34(1):7-11. Epub 2016 Jun 24. — View Citation

Jeon TJ, Park JY. Clinical significance of the neutrophil-lymphocyte ratio as an early predictive marker for adverse outcomes in patients with acute pancreatitis. World J Gastroenterol. 2017 Jun 7;23(21):3883-3889. doi: 10.3748/wjg.v23.i21.3883. — View Citation

Kang HS, Cha YS, Park KH, Hwang SO. Delta neutrophil index as a promising prognostic marker of emergent surgical intervention for acute diverticulitis in the emergency department. PLoS One. 2017 Nov 1;12(11):e0187629. doi: 10.1371/journal.pone.0187629. eCollection 2017. — View Citation

Käser SA, Fankhauser G, Glauser PM, Toia D, Maurer CA. Diagnostic value of inflammation markers in predicting perforation in acute sigmoid diverticulitis. World J Surg. 2010 Nov;34(11):2717-22. doi: 10.1007/s00268-010-0726-7. — View Citation

Mari A, Khoury T, Lubany A, Safadi M, Farraj M, Farah A, Kadah A, Sbeit W, Mahamid M. Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios Are Correlated with Complicated Diverticulitis and Hinchey Classification: A Simple Tool to Assess Disease Severity in the Emergency Department. Emerg Med Int. 2019 Aug 14;2019:6321060. doi: 10.1155/2019/6321060. eCollection 2019. — View Citation

Miyamoto R, Inagawa S, Sano N, Tadano S, Adachi S, Yamamoto M. The neutrophil-to-lymphocyte ratio (NLR) predicts short-term and long-term outcomes in gastric cancer patients. Eur J Surg Oncol. 2018 May;44(5):607-612. doi: 10.1016/j.ejso.2018.02.003. Epub 2018 Feb 13. — View Citation

Reynolds IS, Heaney RM, Khan W, Khan IZ, Waldron R, Barry K. The Utility of Neutrophil to Lymphocyte Ratio as a Predictor of Intervention in Acute Diverticulitis. Dig Surg. 2017;34(3):227-232. doi: 10.1159/000450836. Epub 2016 Dec 10. — View Citation

Wasvary H, Turfah F, Kadro O, Beauregard W. Same hospitalization resection for acute diverticulitis. Am Surg. 1999 Jul;65(7):632-5; discussion 636. — View Citation

Weizman AV, Nguyen GC. Diverticular disease: epidemiology and management. Can J Gastroenterol. 2011 Jul;25(7):385-9. Review. — View Citation

Zager Y, Horesh N, Dan A, Aharoni M, Khalilieh S, Cordoba M, Nevler A, Gutman M, Rosin D. Associations of novel inflammatory markers with long-term outcomes and recurrence of diverticulitis. ANZ J Surg. 2020 Aug 28. doi: 10.1111/ans.16220. [Epub ahead of print] — View Citation

Zahorec R. Neutrophil-to-lymphocyte ratio. Sixteen-year-long history since publication of our article in Bratislava Medical Journal. Bratisl Lek Listy. 2017;118(6):321-323. doi: 10.4149/BLL_2017_062. — View Citation

Zahorec R. Ratio of neutrophil to lymphocyte counts--rapid and simple parameter of systemic inflammation and stress in critically ill. Bratisl Lek Listy. 2001;102(1):5-14. English, Slovak. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographic variables	sex and age	2013-2018
Primary	inpatient stay	days	2013-2018
Primary	level of severity in diverticular process	confirmed by computed tomography	2013-2018
Primary	value of C-reactive protein	normal value under 5 mg/l	2013-2018
Primary	value of Neutrophil to Lymphocyte Ratio	It can be obtained from the blood count (the absolute neutrophil count divided by the absolute lymphocyte count)	2013-2018