Appendicitis AcuteNCT04130074
Role of Duplex Doppler in Accurate Diagnosis of Appendicitis
An observational study of Appendicitis Acute, run by abdelRahman Ahmad abdAllah at 1 site in Egypt.
Trial summary
To evaluate the role of duplex doppler in diagnosis of appendicitis compared to CT Read more about this study
- Who is it for?
- Ages 3 to 60 years
- Conditions the study is for
- Appendicitis Acute
- What is being tested?
- duplex doppler ultra sound and CT
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jul 2020to 15 Mar 2021
- 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 3 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with acute abdomen and suspected appendicitis.
Who may be able to join
- Patients with acute abdomen and suspected appendicitis.
Who cannot join
- so Obese and irritable Patients whom satisfactory graded compression US can't be done.
- pregnant women , children under 3 years old and adults over 60 years old for radiation hazards.
- patients with renal impairment for contrast hazards.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Diagnostic Radiology Department of the assiut university hospital
Asyut, 71511
About this study
Official title: Role of Duplex Doppler In Diagnosis of Acute Appendicitis : in Correlation With Surgical Management Outcome
To evaluate the role of duplex doppler in diagnosis of appendicitis compared to CT
Read the detailed description
Acute appendicitis (AA) is the most common acute abdominal condition worldwide [1]
Thus far, the clinical diagnosis of (AA) remains a challenge to emergency physicians and surgeons both in the pediatric and adult populations, as the symptoms are often atypical and overlapped with various other diseases[2],[3].
The accurate diagnosis of AA depends on both clinical presentations and imaging techniques.
To date, US and computed tomography (CT) remain the most common used diagnostic imaging, and CT is considered the gold standard technique to evaluate patients with suspected AA, because of its high sensitivity and specificity [2],[3]. While the associated radiation exposure remains a concern, especially, among children, the elderly and pregnant women, as radiation protection is of major importance [2],[3],[5],[6].
Over recent years, research on various aspects of US imaging in the diagnosis of (AA) has gained major importance due to its radiation protection, broad availability and cost-effectiveness [6].
Therefore,US may be valuable as an initial imaging choice for patients with suspected (AA) or with equivocal clinical presentations [7],[8].
With continuing efforts to improve the diagnostic performance of US, a variety of US findings have been described for use in the setting of suspected appendicitis, including the maximum outer diameter (MOD), periappendiceal fluid, echogenic periappendiceal fat, and loss of the normally echogenic submucosal layer within the appendiceal wall [9] ,[10].
Color Doppler imaging has been utilized as well, with early reports describing no detectable flow in the normal appendix and later reports, with the benefit of improved instrumentation, d describing flow in normal appendices and hyperemia in inflamed appendices [11],[12].
However, objective criteria for interpreting Doppler results generally have not been specifically described [11],[13],[12],[14].
.Spectral Doppler imaging, in contrast to color Doppler imaging, provides inherently objective, quantitative data such as peak systolic velocity (PSV) and resistive index (RI) values. These measurements have found utility in the assessment of the carotid arteries and, for example, both native as well as transplanted hepatic and renal vessels[16],[17]. Early investigations addressed the RI in appendicitis as well, without emphasis on the PSV, using instrumentation that was modern for the time [18],[19],[20].
- Conditions
- Appendicitis Acute
- Being tested
- duplex doppler ultra sound and CT
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duplex doppler ultra sound and CTDevice
graded compression US done in different positions then take MSCT with contrast on abdomen to compare with
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of duplex Doppler results with CT results
PSV = peak systolic velocity in cm/second , PDV =peak diastolic velocity in cm/second, and PI =( PSV - PDV)/ PSV taken from the intra mural appendiceal artery then compare with the results of MSCT with contrast of the abdomen.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start5 Jul 2020 (estimated)
- Primary completion15 Feb 2021 (estimated)
- Study completion15 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Appendicitis AcuteStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- abdelRahman Ahmad abdAllah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, abdelRahman Ahmad abdAllah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130074
- Sponsor's protocol ID
- US in appendecitis
- Status last verified
- Jun 2020
- First submitted
- 15 Oct 2019
- Last updated
- 5 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Blitman NM, Anwar M, Brady KB, Taragin BH, Freeman K. Value of Focused Appendicitis Ultrasound and Alvarado Score in Predicting Appendicitis in Children: Can We Reduce the Use of CT? AJR Am J Roentgenol. 2015 Jun;204(6):W707-12. doi: 10.2214/AJR.14.13212.
PubMed 26001260Humes DJ, Simpson J. Acute appendicitis. BMJ. 2006 Sep 9;333(7567):530-4. doi: 10.1136/bmj.38940.664363.AE. No abstract available.
PubMed 16960208Shogilev 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 25493136Mostbeck G, Adam EJ, Nielsen MB, Claudon M, Clevert D, Nicolau C, Nyhsen C, Owens CM. How to diagnose acute appendicitis: ultrasound first. Insights Imaging. 2016 Apr;7(2):255-63. doi: 10.1007/s13244-016-0469-6. Epub 2016 Feb 16.
PubMed 26883138Brenner D, Elliston C, Hall E, Berdon W. Estimated risks of radiation-induced fatal cancer from pediatric CT. AJR Am J Roentgenol. 2001 Feb;176(2):289-96. doi: 10.2214/ajr.176.2.1760289.
PubMed 11159059Hernandez JA, Swischuk LE, Angel CA, Chung D, Chandler R, Lee S. Imaging of acute appendicitis: US as the primary imaging modality. Pediatr Radiol. 2005 Apr;35(4):392-5. doi: 10.1007/s00247-004-1372-8. Epub 2005 Jan 6.
PubMed 15635471Rice HE, Arbesman M, Martin DJ, Brown RL, Gollin G, Gilbert JC, Caty MG, Glick PL, Azizkhan RG. Does early ultrasonography affect management of pediatric appendicitis? A prospective analysis. J Pediatr Surg. 1999 May;34(5):754-8; discussion 758-9. doi: 10.1016/s0022-3468(99)90369-x.
PubMed 10359177Chan L, Shin LK, Pai RK, Jeffrey RB. Pathologic continuum of acute appendicitis: sonographic findings and clinical management implications. Ultrasound Q. 2011 Jun;27(2):71-9. doi: 10.1097/RUQ.0b013e31821b6eea.
PubMed 21606789Trout AT, Towbin AJ, Fierke SR, Zhang B, Larson DB. Appendiceal diameter as a predictor of appendicitis in children: improved diagnosis with three diagnostic categories derived from a logistic predictive model. Eur Radiol. 2015 Aug;25(8):2231-8. doi: 10.1007/s00330-015-3639-x. Epub 2015 Apr 28.
PubMed 25916384Ohba G, Hirobe S, Komori K. The Usefulness of Combined B Mode and Doppler Ultrasonography to Guide Treatment of Appendicitis. Eur J Pediatr Surg. 2016 Dec;26(6):533-536. doi: 10.1055/s-0035-1570756. Epub 2016 Jan 8.
PubMed 26745520Gaitini D, Beck-Razi N, Mor-Yosef D, Fischer D, Ben Itzhak O, Krausz MM, Engel A. Diagnosing acute appendicitis in adults: accuracy of color Doppler sonography and MDCT compared with surgery and clinical follow-up. AJR Am J Roentgenol. 2008 May;190(5):1300-6. doi: 10.2214/AJR.07.2955.
PubMed 18430847Kessler N, Cyteval C, Gallix B, Lesnik A, Blayac PM, Pujol J, Bruel JM, Taourel P. Appendicitis: evaluation of sensitivity, specificity, and predictive values of US, Doppler US, and laboratory findings. Radiology. 2004 Feb;230(2):472-8. doi: 10.1148/radiol.2302021520. Epub 2003 Dec 19.
PubMed 14688403Linam LE, Munden M. Sonography as the first line of evaluation in children with suspected acute appendicitis. J Ultrasound Med. 2012 Aug;31(8):1153-7. doi: 10.7863/jum.2012.31.8.1153. No abstract available.
PubMed 22837278Baldisserotto M, Peletti AB. Is colour Doppler sonography a good method to differentiate normal and abnormal appendices in children? Clin Radiol. 2007 Apr;62(4):365-9. doi: 10.1016/j.crad.2006.11.009. Epub 2007 Jan 30.
PubMed 17331831
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Duplex Doppler In Diagnosis of Acute Appendicitis : in Correlation With Surgical Management Outcome
- ClinicalTrials.gov ID
- NCT04130074
- Acronym / sponsor ID
- US in appendecitis
- Conditions
- Appendicitis Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- abdelRahman Ahmad abdAllahUniversity, hospital or other
- Study start
- 5 Jul 2020 (estimated)
- Primary completion
- 15 Feb 2021 (estimated)
- Study completion
- 15 Mar 2021 (estimated)
- First posted
- 17 Oct 2019 (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.
To evaluate the role of duplex doppler in diagnosis of appendicitis compared to CT
Detailed description
Acute appendicitis (AA) is the most common acute abdominal condition worldwide [1]
Thus far, the clinical diagnosis of (AA) remains a challenge to emergency physicians and surgeons both in the pediatric and adult populations, as the symptoms are often atypical and overlapped with various other diseases[2],[3].
The accurate diagnosis of AA depends on both clinical presentations and imaging techniques.
To date, US and computed tomography (CT) remain the most common used diagnostic imaging, and CT is considered the gold standard technique to evaluate patients with suspected AA, because of its high sensitivity and specificity [2],[3]. While the associated radiation exposure remains a concern, especially, among children, the elderly and pregnant women, as radiation protection is of major importance [2],[3],[5],[6].
Over recent years, research on various aspects of US imaging in the diagnosis of (AA) has gained major importance due to its radiation protection, broad availability and cost-effectiveness [6].
Therefore,US may be valuable as an initial imaging choice for patients with suspected (AA) or with equivocal clinical presentations [7],[8].
With continuing efforts to improve the diagnostic performance of US, a variety of US findings have been described for use in the setting of suspected appendicitis, including the maximum outer diameter (MOD), periappendiceal fluid, echogenic periappendiceal fat, and loss of the normally echogenic submucosal layer within the appendiceal wall [9] ,[10].
Color Doppler imaging has been utilized as well, with early reports describing no detectable flow in the normal appendix and later reports, with the benefit of improved instrumentation, d describing flow in normal appendices and hyperemia in inflamed appendices [11],[12].
However, objective criteria for interpreting Doppler results generally have not been specifically described [11],[13],[12],[14].
.Spectral Doppler imaging, in contrast to color Doppler imaging, provides inherently objective, quantitative data such as peak systolic velocity (PSV) and resistive index (RI) values. These measurements have found utility in the assessment of the carotid arteries and, for example, both native as well as transplanted hepatic and renal vessels[16],[17]. Early investigations addressed the RI in appendicitis as well, without emphasis on the PSV, using instrumentation that was modern for the time [18],[19],[20].
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with acute abdomen and suspected appendicitis.
Key inclusion criteria (1 listed)
- Patients with acute abdomen and suspected appendicitis.
Key exclusion criteria (3 listed)
- so Obese and irritable Patients whom satisfactory graded compression US can't be done.
- pregnant women , children under 3 years old and adults over 60 years old for radiation hazards.
- patients with renal impairment for contrast hazards.
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 |
|---|---|---|
| duplex doppler ultra sound and CTgraded compression US done in different positions then take MSCT with contrast on abdomen to compare with | Device | – |
Primary outcome
comparison of duplex Doppler results with CT results
Time frame: baseline
PSV = peak systolic velocity in cm/second , PDV =peak diastolic velocity in cm/second, and PI =( PSV - PDV)/ PSV taken from the intra mural appendiceal artery then compare with the results of MSCT with contrast of the abdomen.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Background: PubMed 26001260Blitman NM, Anwar M, Brady KB, Taragin BH, Freeman K. Value of Focused Appendicitis Ultrasound and Alvarado Score in Predicting Appendicitis in Children: Can We Reduce the Use of CT? AJR Am J Roentgenol. 2015 Jun;204(6):W707-12. doi: 10.2214/AJR.14.13212.
- Background: PubMed 16960208Humes DJ, Simpson J. Acute appendicitis. BMJ. 2006 Sep 9;333(7567):530-4. doi: 10.1136/bmj.38940.664363.AE. No abstract available.
- 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 26883138Mostbeck G, Adam EJ, Nielsen MB, Claudon M, Clevert D, Nicolau C, Nyhsen C, Owens CM. How to diagnose acute appendicitis: ultrasound first. Insights Imaging. 2016 Apr;7(2):255-63. doi: 10.1007/s13244-016-0469-6. Epub 2016 Feb 16.
- Background: PubMed 11159059Brenner D, Elliston C, Hall E, Berdon W. Estimated risks of radiation-induced fatal cancer from pediatric CT. AJR Am J Roentgenol. 2001 Feb;176(2):289-96. doi: 10.2214/ajr.176.2.1760289.
- Background: PubMed 15635471Hernandez JA, Swischuk LE, Angel CA, Chung D, Chandler R, Lee S. Imaging of acute appendicitis: US as the primary imaging modality. Pediatr Radiol. 2005 Apr;35(4):392-5. doi: 10.1007/s00247-004-1372-8. Epub 2005 Jan 6.
- Background: PubMed 10359177Rice HE, Arbesman M, Martin DJ, Brown RL, Gollin G, Gilbert JC, Caty MG, Glick PL, Azizkhan RG. Does early ultrasonography affect management of pediatric appendicitis? A prospective analysis. J Pediatr Surg. 1999 May;34(5):754-8; discussion 758-9. doi: 10.1016/s0022-3468(99)90369-x.
- Background: PubMed 21606789Chan L, Shin LK, Pai RK, Jeffrey RB. Pathologic continuum of acute appendicitis: sonographic findings and clinical management implications. Ultrasound Q. 2011 Jun;27(2):71-9. doi: 10.1097/RUQ.0b013e31821b6eea.
- Background: PubMed 25916384Trout AT, Towbin AJ, Fierke SR, Zhang B, Larson DB. Appendiceal diameter as a predictor of appendicitis in children: improved diagnosis with three diagnostic categories derived from a logistic predictive model. Eur Radiol. 2015 Aug;25(8):2231-8. doi: 10.1007/s00330-015-3639-x. Epub 2015 Apr 28.
- Background: PubMed 26745520Ohba G, Hirobe S, Komori K. The Usefulness of Combined B Mode and Doppler Ultrasonography to Guide Treatment of Appendicitis. Eur J Pediatr Surg. 2016 Dec;26(6):533-536. doi: 10.1055/s-0035-1570756. Epub 2016 Jan 8.
- Background: PubMed 18430847Gaitini D, Beck-Razi N, Mor-Yosef D, Fischer D, Ben Itzhak O, Krausz MM, Engel A. Diagnosing acute appendicitis in adults: accuracy of color Doppler sonography and MDCT compared with surgery and clinical follow-up. AJR Am J Roentgenol. 2008 May;190(5):1300-6. doi: 10.2214/AJR.07.2955.
- Background: PubMed 14688403Kessler N, Cyteval C, Gallix B, Lesnik A, Blayac PM, Pujol J, Bruel JM, Taourel P. Appendicitis: evaluation of sensitivity, specificity, and predictive values of US, Doppler US, and laboratory findings. Radiology. 2004 Feb;230(2):472-8. doi: 10.1148/radiol.2302021520. Epub 2003 Dec 19.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis Acute, run by abdelRahman Ahmad abdAllah at 1 site in Egypt.
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 3 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: status not confirmed, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact abdelrahman ahmed abdallah, bachelor (01006828820, pr.abdo92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of duplex Doppler results with CT results (time frame: baseline). 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 NCT04130074, which also lists 14 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 5 Jun 2020.