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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Appendicitis Acute

Eligibility Criteria

1 Year - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    May 27, 2017
    Last Updated
    June 5, 2017
    Sponsor
    Assiut University
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    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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