Imaging and Histopathological Examination for Evaluation of Pediatric Appendicitis Score

Appendicitis Acute Clinical Trial

Official title:

Imaging and Histopathological Examination for Evaluation of Pediatric Appendicitis Score ( PAS ) as a Diagnostic Tool for Acute Appendicitis in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03171662
• Other study ID #: PASE
• Status: Not yet recruiting
• Phase: N/A
• First received: May 27, 2017
• Last updated: June 5, 2017
• Start date: July 1, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: May 2017
• Source: Assiut University
• Contact: Mahmoud Mostafa, MD
• Phone: 00201005010897
• Email: Profmmmostafa53[@]Gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: December 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 15 Years

Eligibility

Inclusion Criteria:

• Children (1-15 years old) coming to hospital with abdominal pain and diagnosed provisionally as acute appendicitis .

Exclusion Criteria:

1. Children below 1 year old or above 15 years old.

2. Complicated appendicitis ( mass or abcess ).

3. Patient with recent history of any abdominal surgeries.

Related Conditions & MeSH terms

• Appendicitis
• Appendicitis Acute

Intervention

Other:
• Evaluation of Pediatric Appendicitis Score
Imaging and Histopathological examination for Evaluation of Pediatric Appendicitis Score

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pediatric appendicitis score	post-appendectomy histopathology	2 days