Evaluation of the Management of Acute Appendicitis Before Emergency Department in Children: a Prospective Study

May 9, 2021 updated by: University Hospital, Limoges

Acute appendicitis is the first visceral surgical emergency in pediatrics with about 30,000 cases in children having been described in France.

It concerns 0.3% of children under 15 with a maximum frequency between 8 and 13 years of age. Acute appendicitis has a significant morbidity rate of 8% and a mortality rate under 0.1%.

10 to 25% of the children admitted to emergency rooms for abdominal pain have appendicitis.

In 20 to 30% of the cases, the initial symptoms are atypical, which explains the difficulty in diagnosing.

The purpose of our study is to evaluate the quality of general practitioners in the diagnosis of acute appendicitis, its severity and the diagnostic criteria used.

Furthermore, it is not as easy to evaluate pain or examine a complaint in children as it is in adults.

Appendicectomy is the treatment of choice for all acute appendicitis. The importance of early diagnosis and treatment is, therefore, essential. Many predictive diagnostic scores have been studied over the years. The Pediatric Appendicitis Score (PAS) using typical symptoms of acute appendicitis and biological items was published in 2002. Nowadays, it is still considered as a reference and has been validated by other studies.

Most of the patients suffering from abdominal pain first consult their general practitioner.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

11

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 Locations

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 second to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

-Child <16 years with abdominal symptoms and consulting in the pediatric emergency department of Limoges University center.

Description

Inclusion Criteria:

  • Child <16 years
  • abdominal symptoms
  • consulting in the pediatric emergency department of Limoges University center.

Exclusion Criteria:

  • Child >=16 years

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

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PAS score
Time Frame: At 5 month
Score ≤ 5: appendicitis unlikely. Score ≥ 6: probable appendicitis. Score ≥ 7: very probable appendicitis
At 5 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Surgery for appendicitis
Time Frame: At 5 month
At 5 month

Collaborators and Investigators

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

Sponsor

University Hospital, Limoges

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)

June 1, 2021

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

May 9, 2021

First Submitted That Met QC Criteria

May 9, 2021

First Posted (Actual)

May 13, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2021

Last Update Submitted That Met QC Criteria

May 9, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAlouhhey_appendicites

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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