- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05070000
Value of Ultrasound and Computed Tomography in the Diagnosis of Acute Appendicitis With Histopathology as Gold Standard.
October 5, 2021 updated by: Louis Haentjens, KU Leuven
Value of Ultrasound and Computed Tomography in the Diagnosis of Acute Appendicitis With Histopathology as Gold Standard - Retrospective Cohort Study.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
304
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients at the emergency departement with clinical signs of acute appendicitis
Description
Inclusion Criteria:
- suspicion of acute appendicitis
Exclusion Criteria:
- none
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
US
Ultrasound
|
|
|
CT
Computed tomography
|
|
|
US after CT
Ultrasound after Computed tomography
|
Patients underwent US, CT or CT after US
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity and specificity of diagnostic test
Time Frame: 3 years
|
For US and CT sensitivity and specificity for diagnosing acute appendicitis were evaluated.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- 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.
- 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.
- Drake FT, Flum DR. Improvement in the diagnosis of appendicitis. Adv Surg. 2013;47:299-328. doi: 10.1016/j.yasu.2013.03.003.
- 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.
- 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.
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, 2016
Primary Completion (Actual)
December 31, 2018
Study Completion (Actual)
May 31, 2019
Study Registration Dates
First Submitted
July 30, 2021
First Submitted That Met QC Criteria
October 5, 2021
First Posted (Actual)
October 6, 2021
Study Record Updates
Last Update Posted (Actual)
October 6, 2021
Last Update Submitted That Met QC Criteria
October 5, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Appendixstudy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.
Clinical Trials on Appendicitis Acute
-
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