Appendicitis AcuteNCT05070000
Value of Ultrasound and Computed Tomography in the Diagnosis of Acute Appendicitis With Histopathology as Gold Standard.
An observational study of Appendicitis Acute, run by KU Leuven.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Appendicitis Acute
- What is being tested?
- Radiologic examination
- How many people
- 304 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients at the emergency departement with clinical signs of acute appendicitis
Who may be able to join
- suspicion of acute appendicitis
Who cannot join
- none
About this study
Official title: 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.
- Conditions
- Appendicitis Acute
- Being tested
- Radiologic examination
- Keywords
- Appendicitis, General Surgery, Ultrasound, Computed Tomography
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiologic examinationDiagnostic test
Patients underwent US, CT or CT after US
| Study group | Role | What they receive |
|---|---|---|
| US | Ultrasound | |
| CT | Computed tomography | |
| US after CT | Ultrasound after Computed tomography Receives: Diagnostic Test: Radiologic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of diagnostic test
For US and CT sensitivity and specificity for diagnosing acute appendicitis were evaluated.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Jan 2016
- Primary completion31 Dec 2018
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Appendicitis AcuteStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis Haentjens, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070000
- Sponsor's protocol ID
- Appendixstudy
- Status last verified
- Oct 2021
- First submitted
- 30 Jul 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26015876Shogilev 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.
PubMed 25493136Drake FT, Flum DR. Improvement in the diagnosis of appendicitis. Adv Surg. 2013;47:299-328. doi: 10.1016/j.yasu.2013.03.003.
PubMed 24298858Drake 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.
PubMed 24990687Eng 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.
PubMed 29916776Weston 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.
PubMed 16110717Johansson 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.
PubMed 17453494Khan 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.
PubMed 15631364McGowan 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.
PubMed 23231057Meltzer 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.
PubMed 23623557Luckmann 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.
PubMed 1742380Kaiser 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.
PubMed 15343467
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Ultrasound and Computed Tomography in the Diagnosis of Acute Appendicitis With Histopathology as Gold Standard - Retrospective Cohort Study.
- ClinicalTrials.gov ID
- NCT05070000
- Acronym / sponsor ID
- Appendixstudy
- Conditions
- Appendicitis Acute
- Keywords
- Appendicitis, General Surgery, Ultrasound, Computed Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| US | – | –Ultrasound |
| CT | – | –Computed tomography |
| US after CT | – | Diagnostic Test: Radiologic examinationUltrasound after Computed tomography |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients at the emergency departement with clinical signs of acute appendicitis
Key inclusion criteria (1 listed)
- suspicion of acute appendicitis
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiologic examinationPatients underwent US, CT or CT after US | Diagnostic test | US after CT |
Primary outcome
Sensitivity and specificity of diagnostic test
Time frame: 3 years
For US and CT sensitivity and specificity for diagnosing acute appendicitis were evaluated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Background: PubMed 26015876Marzuillo 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.
- Background: PubMed 25493136Shogilev 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.
- Background: PubMed 24298858Drake FT, Flum DR. Improvement in the diagnosis of appendicitis. Adv Surg. 2013;47:299-328. doi: 10.1016/j.yasu.2013.03.003.
- Background: PubMed 24990687Drake 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.
- Results publication: PubMed 29916776Eng 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.
- Results publication: PubMed 16110717Weston 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.
- Results publication: PubMed 17453494Johansson 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.
- Results publication: PubMed 15631364Khan 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.
- Results publication: PubMed 23231057McGowan 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.
- Results publication: PubMed 23623557Meltzer 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.
- Results publication: PubMed 1742380Luckmann 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.
- Results publication: PubMed 15343467Kaiser 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis Acute, run by KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of diagnostic test (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05070000, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.