NCT03171662

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 6, 2017

Status Verified

May 1, 2017

Enrollment Period

1.9 years

First QC Date

May 27, 2017

Last Update Submit

June 5, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • pediatric appendicitis score

    post-appendectomy histopathology

    2 days

Study Arms (1)

group study

EXPERIMENTAL

Imaging and Histopathological examination for Evaluation of Pediatric Appendicitis Score

Other: Evaluation of Pediatric Appendicitis Score

Interventions

Imaging and Histopathological examination for Evaluation of Pediatric Appendicitis Score

group study

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Children below 1 year old or above 15 years old.
  • Complicated appendicitis ( mass or abcess ).
  • Patient with recent history of any abdominal surgeries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Central Study Contacts

Mahmoud Mostafa, MD

CONTACT

Ibrahim Ali Ibrahim, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

May 27, 2017

First Posted

May 31, 2017

Study Start

July 1, 2017

Primary Completion

June 1, 2019

Study Completion

December 1, 2019

Last Updated

June 6, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share