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

NCT07479849 | Not Yet Recruiting

• 2 other identifiers: 49RC24_02512025-A02854-45
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Appendicitis

Keywords

telediagnosis; validation study; Pediatric medicine

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of the teleconsultation-based appendicitis score

  Area Under the Receiver Operating Characteristic Curve (AUC ≥ 0.75), with an overall diagnostic accuracy (accuracy ≥ 0.80)

  Baseline and Day 15

Secondary Outcomes (5)

• Non-inferiority of the teleconsultation-based score compared with standard pediatric emergency consultation diagnosis

  Baseline and Day 15

• Additional performance metrics of the predictive models

  Baseline and Day 15

• Feasibility and acceptability of parent-assisted clinical examination

  Baseline

• Association between teleconsultation-based scores and clinical diagnosis probability assessed by the investigator

  Baseline

• Distribution of teleconsultation-based scores across alternative (non-appendicitis) diagnoses

  Baseline and Day 15

Study Arms (2)

High risk group of children according to diagnostic score of appendicitis

OTHER

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

Diagnostic Test: Score-based appendicitis risk classification in teleconsultation

Low risk group of children according to diagnostic score of appendicitis

OTHER

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

Diagnostic Test: Score-based appendicitis risk classification in teleconsultation

Interventions

Score-based appendicitis risk classification in teleconsultation DIAGNOSTIC_TEST

Medical students will use a diagnostic grid of 10 items (3 medical interview items and 7 clinical examination items) rated each from 0 to 2 when receiving children with abdominal pain in emergency room. As in teleconsultation, parents will be asked to follow and execute instructions (delivered by medical students). A diagnostic score will be established for each patient. After these procedures, children will receive standard care provided by emergency physicians

High risk group of children according to diagnostic score of appendicitis; Low risk group of children according to diagnostic score of appendicitis

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Angers, University Hospital

Angers, 49000, France

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Lydia FLAUX, Medical Doctor

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lydia FLAUX, Medical Doctor

CONTACT

+33 (0)2.41.35.44.10; Lydia.Flaux@chu-angers.fr

Matthieu LE LAY

CONTACT

+33 (0)2 41 35 58 91; DRCI-Promotion-Interne@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: March 18, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

FR (1)