- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04130074
Role of Duplex Doppler in Accurate Diagnosis of Appendicitis
Role of Duplex Doppler In Diagnosis of Acute Appendicitis : in Correlation With Surgical Management Outcome
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: abdelrahman ahmed abdallah, bachelor
- Phone Number: 01006828820
- Email: pr.abdo92@gmail.com
Study Contact Backup
- Name: Gehan Sayed Ahmed, assistant professor
- Phone Number: 01224417605
- Email: gehanseifeldein@aun.edu.eg
Study Locations
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Assiut, Egypt, 71511
- Diagnostic Radiology Department of the assiut university hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with acute abdomen and suspected appendicitis.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
comparison of duplex Doppler results with CT results
Time Frame: baseline
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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.
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baseline
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Brenner 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.
- 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.
- Humes DJ, Simpson J. Acute appendicitis. BMJ. 2006 Sep 9;333(7567):530-4. doi: 10.1136/bmj.38940.664363.AE. No abstract available.
- 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.
- Mostbeck 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.
- Hernandez 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.
- Rice 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.
- Chan 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.
- Trout 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.
- Ohba 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.
- Gaitini 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.
- Kessler 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.
- Linam 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.
- Baldisserotto 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- US in appendecitis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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