NCT05070000

Brief Summary

This study is a retrospective evaluation of all patients treated surgically for appendicitis over a period of 3 years at the Sint- Andries Hospital, Tielt. Belgium. The goal is to evaluate the value of ultrasound (US), computed tomography (CT) and laboratory testing in diagnosing acute appendicitis and to look for the possible impact on the treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
304

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

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, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
Last Updated

October 6, 2021

Status Verified

October 1, 2021

Enrollment Period

3 years

First QC Date

July 30, 2021

Last Update Submit

October 5, 2021

Conditions

Keywords

AppendicitisGeneral SurgeryUltrasoundComputed Tomography

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of diagnostic test

    For US and CT sensitivity and specificity for diagnosing acute appendicitis were evaluated.

    3 years

Study Arms (3)

US

Ultrasound

CT

Computed tomography

US after CT

Ultrasound after Computed tomography

Diagnostic Test: Radiologic examination

Interventions

Radiologic examinationDIAGNOSTIC_TEST

Patients underwent US, CT or CT after US

US after CT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients at the emergency departement with clinical signs of acute appendicitis

You may qualify if:

  • suspicion of acute appendicitis

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Marzuillo P, Germani C, Krauss BS, Barbi E. Appendicitis in children less than five years old: A challenge for the general practitioner. World J Clin Pediatr. 2015 May 8;4(2):19-24. doi: 10.5409/wjcp.v4.i2.19. eCollection 2015 May 8.

    PMID: 26015876BACKGROUND
  • Shogilev DJ, Duus N, Odom SR, Shapiro NI. Diagnosing appendicitis: evidence-based review of the diagnostic approach in 2014. West J Emerg Med. 2014 Nov;15(7):859-71. doi: 10.5811/westjem.2014.9.21568. Epub 2014 Oct 7.

    PMID: 25493136BACKGROUND
  • Drake FT, Flum DR. Improvement in the diagnosis of appendicitis. Adv Surg. 2013;47:299-328. doi: 10.1016/j.yasu.2013.03.003.

    PMID: 24298858BACKGROUND
  • Drake FT, Mottey NE, Farrokhi ET, Florence MG, Johnson MG, Mock C, Steele SR, Thirlby RC, Flum DR. Time to appendectomy and risk of perforation in acute appendicitis. JAMA Surg. 2014 Aug;149(8):837-44. doi: 10.1001/jamasurg.2014.77.

    PMID: 24990687BACKGROUND
  • Eng KA, Abadeh A, Ligocki C, Lee YK, Moineddin R, Adams-Webber T, Schuh S, Doria AS. Acute Appendicitis: A Meta-Analysis of the Diagnostic Accuracy of US, CT, and MRI as Second-Line Imaging Tests after an Initial US. Radiology. 2018 Sep;288(3):717-727. doi: 10.1148/radiol.2018180318. Epub 2018 Jun 19.

  • Weston AR, Jackson TJ, Blamey S. Diagnosis of appendicitis in adults by ultrasonography or computed tomography: a systematic review and meta-analysis. Int J Technol Assess Health Care. 2005 Summer;21(3):368-79. doi: 10.1017/s0266462305050488.

  • Johansson EP, Rydh A, Riklund KA. Ultrasound, computed tomography, and laboratory findings in the diagnosis of appendicitis. Acta Radiol. 2007 Apr;48(3):267-73. doi: 10.1080/02841850601182162.

  • Khan MN, Davie E, Irshad K. The role of white cell count and C-reactive protein in the diagnosis of acute appendicitis. J Ayub Med Coll Abbottabad. 2004 Jul-Sep;16(3):17-9.

  • McGowan DR, Sims HM, Zia K, Uheba M, Shaikh IA. The value of biochemical markers in predicting a perforation in acute appendicitis. ANZ J Surg. 2013 Jan;83(1-2):79-83. doi: 10.1111/ans.12032. Epub 2012 Dec 12.

  • Meltzer AC, Baumann BM, Chen EH, Shofer FS, Mills AM. Poor sensitivity of a modified Alvarado score in adults with suspected appendicitis. Ann Emerg Med. 2013 Aug;62(2):126-31. doi: 10.1016/j.annemergmed.2013.01.021. Epub 2013 Apr 24.

  • Luckmann R, Davis P. The epidemiology of acute appendicitis in California: racial, gender, and seasonal variation. Epidemiology. 1991 Sep;2(5):323-30. doi: 10.1097/00001648-199109000-00003.

  • Kaiser S, Mesas-Burgos C, Soderman E, Frenckner B. Appendicitis in children--impact of US and CT on the negative appendectomy rate. Eur J Pediatr Surg. 2004 Aug;14(4):260-4. doi: 10.1055/s-2004-817841.

MeSH Terms

Conditions

Appendicitis

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

July 30, 2021

First Posted

October 6, 2021

Study Start

January 1, 2016

Primary Completion

December 31, 2018

Study Completion

May 31, 2019

Last Updated

October 6, 2021

Record last verified: 2021-10