NCT04885335

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

May 13, 2021

Status Verified

May 1, 2021

Enrollment Period

8 months

First QC Date

May 9, 2021

Last Update Submit

May 9, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • PAS score

    Score ≤ 5: appendicitis unlikely. Score ≥ 6: probable appendicitis. Score ≥ 7: very probable appendicitis

    At 5 month

Secondary Outcomes (1)

  • Surgery for appendicitis

    At 5 month

Interventions

Score ≤ 5: appendicitis unlikely. Score ≥ 6: probable appendicitis. core ≥ 7: very probable appendicitis

Eligibility Criteria

Age0 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Child \>=16 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric emergency department

Limoges, 87000, France

Location

Related Publications (1)

  • Vevaud K, Dallocchio A, Dumoitier N, Laspougeas A, Labrunie A, Belgacem A, Fourcade L, Ballouhey Q. A prospective study to evaluate the contribution of the pediatric appendicitis score in the decision process. BMC Pediatr. 2024 Feb 19;24(1):131. doi: 10.1186/s12887-024-04619-z.

MeSH Terms

Conditions

Appendicitis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Quentin Ballouhey, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2021

First Posted

May 13, 2021

Study Start

June 1, 2021

Primary Completion

February 1, 2022

Study Completion

June 1, 2022

Last Updated

May 13, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations