NCT05033249

Brief Summary

Acute appendicitis is the most common cause of abdominal pain requiring surgery in the emergency department. The whole life acute appendicitis rate is 7%. Only half of the patients with acute appendicitis are presented with typical periumbilical pain following by nausea, vomiting, and the migration of pain to the right lower quadrant. The diagnosis of acute appendicitis is based on the patient's medical history, physical examination, and laboratory findings. The Alvarado scoring system (ASS), recommends discharge, observation, and surgical intervention to patients. However, such scoring systems should not be used as the only method in diagnosis. Increased imaging use in patients with suspected acute appendicitis improved the rate of correct diagnosis. American College of Radiology Appropriateness Criteria (ACR) recommends computerized tomography (CT) as the primary imaging method to confirm the diagnosis of acute appendicitis in adults. However, CT imaging has some disadvantages, such as radiation exposure, undesirable effects associated with the use of contrast agents, and increased workload in the emergency room. The count of immature granulocytes (IGC), which is an indicator of increased activation of the bone marrow, and the percentage of IG (IGP), which is the ratio of IGs to the total white blood cell count, are also has been used differentiation of complicated acute appendicitis from uncomplicated acute appendicitis, and other inflammatory pathologies. Nowadays automatic blood analyzers can easily measure the amount and percentage of IGs simultaneously in a complete blood count test with advances in technology. It is aimed to investigate the utility of IGC and IGP on the prediction of suspected acute appendicitis according to the ASS and its effect on the need for CT scanning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 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, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

June 19, 2021

Last Update Submit

February 21, 2024

Conditions

Keywords

Acute appendicitisComputed TomographyImmature granulocyte countImmature granulocyte percentageAlvarado Scoring System

Outcome Measures

Primary Outcomes (2)

  • The utility of Immature granulocyte count on determining clinically suspected acute appendicitis cases and diminishing computed tomography need

    Automatically counted immature granulocyte count can help to determine acute appendicitis cases and diminish the need for computed tomography in patients who admitted to the emergency room and ALVARADO score between 4 - 7.

    January 2019 - July 2019

  • The utility of Immature granulocyte percentage on determining clinically suspected acute appendicitis cases and diminishing computed tomography need

    Automatically calculated immature granulocyte percentage can help to determine acute appendicitis cases and diminish the need for computed tomography in patients who admitted to the emergency room and ALVARADO score between 4 - 7.

    January 2019 - July 2019

Study Arms (2)

Normal

Alvarado Score 4 - 7 Normal according to the initial computed tomographic evaluation

Diagnostic Test: Immature granulocyte countDiagnostic Test: Immature granulocyte percentage

Patient

Alvarado Score 4 - 7 Acute appendicitis according to the initial computed tomographic evaluation

Diagnostic Test: Immature granulocyte countDiagnostic Test: Immature granulocyte percentage

Interventions

Automatically calculated immature granulocyte count in white blood cell count

NormalPatient

Automatically calculated immature granulocyte percentage in white blood cell count

NormalPatient

Eligibility Criteria

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

Patients with abdominal pain admitted to the emergency room and whose calculated ALVARADO score was between 4 and 7. According to this result computed tomographic evaluation applied to these patients.

You may qualify if:

  • Age \> 18 years
  • Patients complaining about abdominal pain
  • Calculated ALVARADO Score 4-7
  • Whose initial imaging technique was CT

You may not qualify if:

  • Patients diagnosed with other imaging methods (eg, ultrasonography)
  • Patients who underwent surgery without imaging modalities
  • Patients who were followed by medical treatment without surgery
  • Pregnant patients
  • Age \<18
  • Patients with incomplete medical records
  • Patients with additional diseases which can affect the blood parameters (such as underlying hematologic or rheumatologic disease, laignancies, other concurrent infectious diseases)
  • Patients whom were treated with granulocyte colony-stimulating factors, glucocorticoids, or other immunosuppressants that may affect inflammation markers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sütçü İmam University

Kahramanmaraş, 46000, Turkey (Türkiye)

Location

Related Publications (14)

  • Ohle R, O'Reilly F, O'Brien KK, Fahey T, Dimitrov BD. The Alvarado score for predicting acute appendicitis: a systematic review. BMC Med. 2011 Dec 28;9:139. doi: 10.1186/1741-7015-9-139.

    PMID: 22204638BACKGROUND
  • Hosseini M, Tizmaghz A, Shabestanipour G, Aein A, Otaghvar H. The Frequency of Different Clinical Presentation of Appendicitis, Complications and Prognosis in Elderly. Annu Res Rev Biol. 2014;4(24):4381-8

    BACKGROUND
  • Shuaib A, Shuaib A, Fakhra Z, Marafi B, Alsharaf K, Behbehani A. Evaluation of modified Alvarado scoring system and RIPASA scoring system as diagnostic tools of acute appendicitis. World J Emerg Med. 2017;8(4):276-280. doi: 10.5847/wjem.j.1920-8642.2017.04.005.

    PMID: 29123605BACKGROUND
  • Dal F, Cicek Y, Pekmezci S, Kocazeybek B, Tokman HB, Konukoglu D, Simsek O, Taner Z, Sirekbasan S, Uludag SS. Role of Alvarado score and biological indicators of C-reactive protein, procalicitonin and neopterin in diagnosis of acute appendicitis. Ulus Travma Acil Cerrahi Derg. 2019 May;25(3):229-237. doi: 10.5505/tjtes.2018.57362.

    PMID: 31135946BACKGROUND
  • Tintinalli JE, Stapczynski JS, Ma OJ, Cline DM, Cydulka Rk MG, editor. Gastrointestinal Emergencies. In: Tintinalli's Emergency Medicine: A Comprehensive Study Guide. 7th ed. New York: McGraw-Hill Medical; 2010

    BACKGROUND
  • Rosen MP, Ding A, Blake MA, Baker ME, Cash BD, Fidler JL, Grant TH, Greene FL, Jones B, Katz DS, Lalani T, Miller FH, Small WC, Spottswood S, Sudakoff GS, Tulchinsky M, Warshauer DM, Yee J, Coley BD. ACR Appropriateness Criteria(R) right lower quadrant pain--suspected appendicitis. J Am Coll Radiol. 2011 Nov;8(11):749-55. doi: 10.1016/j.jacr.2011.07.010.

    PMID: 22051456BACKGROUND
  • Smith MP, Katz DS, Lalani T, Carucci LR, Cash BD, Kim DH, Piorkowski RJ, Small WC, Spottswood SE, Tulchinsky M, Yaghmai V, Yee J, Rosen MP. ACR Appropriateness Criteria(R) Right Lower Quadrant Pain--Suspected Appendicitis. Ultrasound Q. 2015 Jun;31(2):85-91. doi: 10.1097/RUQ.0000000000000118.

    PMID: 25364964BACKGROUND
  • Unal Y, Barlas AM. Role of increased immature granulocyte percentage in the early prediction of acute necrotizing pancreatitis. Ulus Travma Acil Cerrahi Derg. 2019 Mar;25(2):177-182. doi: 10.14744/tjtes.2019.70679.

    PMID: 30892679BACKGROUND
  • Unal Y. A new and early marker in the diagnosis of acute complicated appendicitis: immature granulocytes. Ulus Travma Acil Cerrahi Derg. 2018 Sep;24(5):434-439. doi: 10.5505/tjtes.2018.91661.

    PMID: 30394497BACKGROUND
  • Bozan MB, Yazar FM, Kale IT, Yuzbasioglu MF, Boran OF, Azak Bozan A. Delta Neutrophil Index and Neutrophil-to-Lymphocyte Ratio in the Differentiation of Thyroid Malignancy and Nodular Goiter. World J Surg. 2021 Feb;45(2):507-514. doi: 10.1007/s00268-020-05822-6. Epub 2020 Oct 16.

    PMID: 33067685BACKGROUND
  • Barut O, Demirkol MK, Bilecan EB, Sahinkanat T, Resim S. The Delta Neutrophil Index is an Early Predictive Marker of Acute Pyelonephritis in Patients with Ureteral Stone. J Coll Physicians Surg Pak. 2020 Nov;30(11):1149-1154. doi: 10.29271/jcpsp.2020.11.1149.

    PMID: 33222730BACKGROUND
  • Kong T, Park YS, Lee HS, Kim S, Lee JW, You JS, Chung HS, Park I, Chung SP. The delta neutrophil index predicts development of multiple organ dysfunction syndrome and 30-day mortality in trauma patients admitted to an intensive care unit: a retrospective analysis. Sci Rep. 2018 Nov 30;8(1):17515. doi: 10.1038/s41598-018-35796-4.

    PMID: 30504778BACKGROUND
  • Shin DH, Cho YS, Cho GC, Ahn HC, Park SM, Lim SW, Oh YT, Cho JW, Park SO, Lee YH. Delta neutrophil index as an early predictor of acute appendicitis and acute complicated appendicitis in adults. World J Emerg Surg. 2017 Jul 24;12:32. doi: 10.1186/s13017-017-0140-7. eCollection 2017.

    PMID: 28747992BACKGROUND
  • Barut O, Demirkol MK, Kucukdurmaz F, Sahinkanat T, Resim S. Pre-treatment Delta Neutrophil Index as a Predictive Factor in Renal Cell Carcinoma. J Coll Physicians Surg Pak. 2021 Feb;31(2):156-161. doi: 10.29271/jcpsp.2021.02.156.

    PMID: 33645181BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Assistant

Study Record Dates

First Submitted

June 19, 2021

First Posted

September 2, 2021

Study Start

January 1, 2019

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

February 23, 2024

Record last verified: 2024-02

Locations