Imaging and Histopathological Examination for Evaluation of Pediatric Appendicitis Score

June 5, 2017 updated by: Michael Samir Rateeb, Assiut University

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

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.

Study Overview

Status

Unknown

Conditions

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

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2017

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

May 27, 2017

First Submitted That Met QC Criteria

May 30, 2017

First Posted (ACTUAL)

May 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 6, 2017

Last Update Submitted That Met QC Criteria

June 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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