TACTILE : Validation of a Teleconsultation-Based Predictive Score for the Diagnosis of Acute Appendicitis in Children Using Artificial Intelligence Methods

University Hospital, Angers

Status: Begins enrollment in 1 month

Conditions: Acute Appendicitis

Treatments: Diagnostic Test: Score-based appendicitis risk classification in teleconsultation

Study type: Interventional

Funder types: Other

Identifiers

NCT07479849

49RC24_0251

2025-A02854-45 (Other Identifier)

Details and patient eligibility

About

Acute appendicitis is the most common abdominal surgical emergency in children and a frequent cause of pediatric emergency department visits. Diagnosis may be challenging due to variable clinical presentations and overlapping symptoms with other causes of abdominal pain. The increasing use of telemedicine further limits access to direct physical examination.

This study aims to evaluate and validate a predictive clinical score designed for teleconsultation to estimate the probability of acute appendicitis in children. The score is based on symptom history and simple clinical signs assessed remotely with the assistance of a parenton a 10 item checklist. During an emergency visit for acute abdominal pain, voluntary children aged 3 to 16 years and their parents will be guided by a medical student through the checklist in conditions simulating a teleconsultation. The score will be recorded for research purposes only and will not influence clinical management. All participants will subsequently undergo standard medical evaluation and management by an emergency physician, who will independently assess the probability of acute appendicitis based on routine clinical practice. The diagnostic performance of the simulated teleconsultation will then be evaluated using advanced statistical and artificial intelligence-based methods and compared with standard in-person pediatric emergency consultation.

Full description

Several clinical prediction models exist for pediatric appendicitis; however, most require laboratory or imaging data and are not suitable for telemedicine settings. To address this limitation, a teleconsultation-oriented diagnostic checklist was developed using a Delphi consensus methodology. The checklist includes 10 items: three symptom-related questions (pain location, fever, upper digestive symptoms) and seven simple clinical examination items, yielding a total score ranging from 0 to 16.

This prospective, single-center study will be conducted in the pediatric emergency department of Angers University Hospital, France. Children aged 3 to 16 years presenting with non-specific abdominal pain will be eligible. During the emergency visit, a medical student will guide the child and parent through the checklist in conditions simulating a teleconsultation. The score will be recorded for research purposes only and will not influence clinical management.

All participants will subsequently undergo standard medical evaluation and management by an emergency physician, who will independently assess the probability of acute appendicitis based on routine clinical practice. Parents and clinicians will complete questionnaires evaluating feasibility, acceptability, and perceived usefulness of the teleconsultation-based assessment.

Participants will be followed for 15 days to establish the final diagnosis of appendicitis or alternative conditions, using hospital medical records or structured follow-up questionnaires for patients discharged home.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 3 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children aged 3 to 16 years
• Presentation to the pediatric emergency department with unexplained abdominal pain
• Affiliation with a social security or health insurance system
• Written informed consent from a legal guardian and assent from the child, when applicable

Exclusion criteria

• Previous appendectomy
• Hemodynamic instability
• Known medical condition likely to cause chronic or recurrent abdominal pain
• Inability of the child or parents to understand French
• Referral with prior laboratory or imaging investigations
• Participation in the study within the previous 48 hours

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

High risk group of children according to diagnostic score of appendicitis

Other group

Description:

After diagnostic score assessment, children are assigned to the High risk group using computational technique from artificial intelligence then followed-up for 15 days

Treatment:

Diagnostic Test: Score-based appendicitis risk classification in teleconsultation

Low risk group of children according to diagnostic score of appendicitis

Other group

Description:

After diagnostic score assessment, children are assigned to the Low risk group using computational technique from artificial intelligence then followed-up for 15 days

Treatment:

Diagnostic Test: Score-based appendicitis risk classification in teleconsultation