- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03171662
Imaging and Histopathological Examination for Evaluation of Pediatric Appendicitis Score
Imaging and Histopathological Examination for Evaluation of Pediatric Appendicitis Score ( PAS ) as a Diagnostic Tool for Acute Appendicitis in Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The diagnostic difficulties result in increased risks of both negative appendectomies and a delayed diagnosis, both leading to increased morbidity, more complications, longer hospital stay, and higher costs. These risks are further increased in the younger children. The doctor delay is a known cause contributing to late diagnosis in young children. Other studies, with patients under 3 years and 4 years of age, have found parent delay to contribute as well to the late diagnosis. Our clinical experience, confirmed by the literature, shows that the younger children with acute appendicitis deviate from the typical presentation and clinical findings observed in older children with acute appendicitis.
The use of a clinical score, based on patient history and examination, is one way to possibly improve the diagnostic procedure. There are several available scores. In this systematic review, Pediatric Appendicitis Score (PAS) were considered the most reliable. Pediatric Appendicitis Score is the only score specifically developed for children, composed by Samuel in 2002 when analyzing children between 4 and 15 years of age. Pediatric Appendicitis Score has been validated and recommended by some authors, but only one of these studies has included children less than 4 years of age.
We hypothesized that PAS could be helpful in diagnosing young children with appendicitis and that we would find both parent delay and doctor delay contributing to the often late diagnosis in this age group. The aims of this study were to (1) evaluate Pediatric Appendicitis Score in children, operated on for suspected appendicitis, with respect to Pediatric Appendicitis Score sensitivity, specificity, positive predictive value, and negative predictive value; (2) investigate if there was a delay in diagnosing appendicitis; and (3) identify factors responsible for the possible late diagnosis in younger children In order to improve the diagnostic accuracy of acute appendicitis, ultrasound, computed tomography and post-appendectomy histopathological examination have been used as clinical aids in cutting down the rate of negative appendectomy without increasing morbidity and mortality.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mahmoud Mostafa, MD
- Phone Number: 00201005010897
- Email: Profmmmostafa53@Gmail.com
Study Contact Backup
- Name: Ibrahim Ali Ibrahim, MD
- Phone Number: 00201005801291
- Email: Dr.Ibrahimali@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children (1-15 years old) coming to hospital with abdominal pain and diagnosed provisionally as acute appendicitis .
Exclusion Criteria:
- Children below 1 year old or above 15 years old.
- Complicated appendicitis ( mass or abcess ).
- Patient with recent history of any abdominal surgeries.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: group study
Imaging and Histopathological examination for Evaluation of Pediatric Appendicitis Score
|
Imaging and Histopathological examination for Evaluation of Pediatric Appendicitis Score
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pediatric appendicitis score
Time Frame: 2 days
|
post-appendectomy histopathology
|
2 days
|
Collaborators and Investigators
Sponsor
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
- PASE
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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