NCT04663490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
Last Updated

December 11, 2020

Status Verified

December 1, 2020

Enrollment Period

5 years

First QC Date

November 30, 2020

Last Update Submit

December 6, 2020

Conditions

Keywords

neutrophil-to-lymphocyte ratioC-reactive proteinbiomarkers

Outcome Measures

Primary Outcomes (5)

  • Demographic variables

    sex and age

    2013-2018

  • inpatient stay

    days

    2013-2018

  • level of severity in diverticular process

    confirmed by computed tomography

    2013-2018

  • value of C-reactive protein

    normal value under 5 mg/l

    2013-2018

  • 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

Study Arms (2)

simple acute diverticulitis

Ninety-one percent (n=295) were categorized as simple acute diverticulitis

Diagnostic Test: Neutrophil to Lymphocyte Ratio

complicated acute diverticulitis

9% (n=30) presented were categorized as complicated acute diverticulitis

Diagnostic Test: Neutrophil to Lymphocyte Ratio

Interventions

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 diverticulitissimple acute diverticulitis

Eligibility Criteria

Age18 Years - 92 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

325 patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Universitaria Reina Fabiola

Córdoba, 5000, Argentina

Location

Related Publications (17)

  • Weizman AV, Nguyen GC. Diverticular disease: epidemiology and management. Can J Gastroenterol. 2011 Jul;25(7):385-9. doi: 10.1155/2011/795241.

    PMID: 21876861BACKGROUND
  • Feingold D, Steele SR, Lee S, Kaiser A, Boushey R, Buie WD, Rafferty JF. Practice parameters for the treatment of sigmoid diverticulitis. Dis Colon Rectum. 2014 Mar;57(3):284-94. doi: 10.1097/DCR.0000000000000075. No abstract available.

    PMID: 24509449BACKGROUND
  • Barat M, Dohan A, Pautrat K, Boudiaf M, Dautry R, Guerrache Y, Pocard M, Hoeffel C, Eveno C, Soyer P. Acute colonic diverticulitis: an update on clinical classification and management with MDCT correlation. Abdom Radiol (NY). 2016 Sep;41(9):1842-50. doi: 10.1007/s00261-016-0764-1.

    PMID: 27138434BACKGROUND
  • Wasvary H, Turfah F, Kadro O, Beauregard W. Same hospitalization resection for acute diverticulitis. Am Surg. 1999 Jul;65(7):632-5; discussion 636.

    PMID: 10399971BACKGROUND
  • Bates DDB, Fernandez MB, Ponchiardi C, von Plato M, Teich JP, Narsule C, Anderson SW, Gupta A, LeBedis CA. Surgical management in acute diverticulitis and its association with multi-detector CT, modified Hinchey classification, and clinical parameters. Abdom Radiol (NY). 2018 Aug;43(8):2060-2065. doi: 10.1007/s00261-017-1422-y.

    PMID: 29204676BACKGROUND
  • Kaser 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.

    PMID: 20645093BACKGROUND
  • 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.

    PMID: 11723675BACKGROUND
  • 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. No abstract available.

    PMID: 28664739BACKGROUND
  • 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.

    PMID: 29478743BACKGROUND
  • 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.

    PMID: 27941316BACKGROUND
  • 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. doi: 10.1159/000447250. Epub 2016 Jun 24.

    PMID: 27336407BACKGROUND
  • 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 Oct;90(10):2041-2045. doi: 10.1111/ans.16220. Epub 2020 Aug 28.

    PMID: 32856387BACKGROUND
  • 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.

    PMID: 31485352BACKGROUND
  • 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.

    PMID: 29091955BACKGROUND
  • 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.

    PMID: 28890409BACKGROUND
  • 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.

    PMID: 28638228BACKGROUND
  • Bharucha AE, Parthasarathy G, Ditah I, Fletcher JG, Ewelukwa O, Pendlimari R, Yawn BP, Melton LJ, Schleck C, Zinsmeister AR. Temporal Trends in the Incidence and Natural History of Diverticulitis: A Population-Based Study. Am J Gastroenterol. 2015 Nov;110(11):1589-96. doi: 10.1038/ajg.2015.302. Epub 2015 Sep 29.

    PMID: 26416187BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgeon

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 11, 2020

Study Start

January 1, 2013

Primary Completion

January 1, 2018

Study Completion

January 1, 2020

Last Updated

December 11, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Due to the sensitive nature of the study, patients were assured that the raw data would remain confidential and would not be shared.

Locations