NCT04130074

Brief Summary

To evaluate the role of duplex doppler in diagnosis of appendicitis compared to CT

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

July 5, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

June 5, 2020

Status Verified

June 1, 2020

Enrollment Period

8 months

First QC Date

October 15, 2019

Last Update Submit

June 4, 2020

Conditions

Appendicitis Acute

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline

Interventions

duplex doppler ultra sound and CTDEVICE

graded compression US done in different positions then take MSCT with contrast on abdomen to compare with

Eligibility Criteria

Age3 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute abdomen and suspected appendicitis.

You may qualify if:

  • Patients with acute abdomen and suspected appendicitis.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diagnostic Radiology Department of the assiut university hospital

Asyut, 71511, Egypt

Location

Related Publications (14)

  • 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.

    PMID: 26001260BACKGROUND

  • Humes DJ, Simpson J. Acute appendicitis. BMJ. 2006 Sep 9;333(7567):530-4. doi: 10.1136/bmj.38940.664363.AE. No abstract available.

    PMID: 16960208BACKGROUND

  • 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

  • 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.

    PMID: 26883138BACKGROUND

  • 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.

    PMID: 11159059BACKGROUND

  • 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.

    PMID: 15635471BACKGROUND

  • 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.

    PMID: 10359177BACKGROUND

  • 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.

    PMID: 21606789BACKGROUND

  • 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.

    PMID: 25916384BACKGROUND

  • 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.

    PMID: 26745520BACKGROUND

  • 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.

    PMID: 18430847BACKGROUND

  • 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.

    PMID: 14688403BACKGROUND

  • 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.

    PMID: 22837278BACKGROUND

  • 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.

    PMID: 17331831BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Central Study Contacts

abdelrahman ahmed abdallah, bachelor

CONTACT

01006828820pr.abdo92@gmail.com

Gehan Sayed Ahmed, assistant professor

CONTACT

01224417605gehanseifeldein@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

October 15, 2019

First Posted

October 17, 2019

Study Start

July 5, 2020

Primary Completion

February 15, 2021

Study Completion

March 15, 2021

Last Updated

June 5, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)