Imaging and Histopathological Examination for Evaluation of Pediatric Appendicitis Score
Primary Purpose
Appendicitis Acute
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Evaluation of Pediatric Appendicitis Score
Sponsored by
About this trial
This is an interventional diagnostic trial for Appendicitis Acute
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
group study
Arm Description
Imaging and Histopathological examination for Evaluation of Pediatric Appendicitis Score
Outcomes
Primary Outcome Measures
pediatric appendicitis score
post-appendectomy histopathology
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03171662
Brief Title
Imaging and Histopathological Examination for Evaluation of Pediatric Appendicitis Score
Official Title
Imaging and Histopathological Examination for Evaluation of Pediatric Appendicitis Score ( PAS ) as a Diagnostic Tool for Acute Appendicitis in Children
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Anticipated)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Appendicitis is the most common abdominal disease requiring surgery in children. The risk of developing appendicitis during a lifetime is reported to be 8.7% for boys and 6.7% for girls. Despite its high incidence, there are still diagnostic difficulties. The overall negative appendectomy rate among all children is suggested to be 8.4%, but in children under 6 years of age, the rate has been reported to be as high as 56.7% . The diagnosis of acute appendicitis is considered to be especially challenging in children due to difficulties in communication and examination.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis Acute
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group study
Arm Type
Experimental
Arm Description
Imaging and Histopathological examination for Evaluation of Pediatric Appendicitis Score
Intervention Type
Other
Intervention Name(s)
Evaluation of Pediatric Appendicitis Score
Intervention Description
Imaging and Histopathological examination for Evaluation of Pediatric Appendicitis Score
Primary Outcome Measure Information:
Title
pediatric appendicitis score
Description
post-appendectomy histopathology
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Mostafa, MD
Phone
00201005010897
Email
Profmmmostafa53@Gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ibrahim Ali Ibrahim, MD
Phone
00201005801291
Email
Dr.Ibrahimali@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Imaging and Histopathological Examination for Evaluation of Pediatric Appendicitis Score
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