Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07479849

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Acute Appendicitis Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Diagnostic performance of the teleconsultation-based appendicitis score

    Time frame: Baseline and Day 15

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

Secondary outcomes

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

    Time frame: Baseline and Day 15

    AUC non-inferiority margin of 0.1

  2. Additional performance metrics of the predictive models

    Time frame: Baseline and Day 15

    sensitivity, specificity, precision, recall, AUC-precision recall

  3. Feasibility and acceptability of parent-assisted clinical examination

    Time frame: Baseline

    assessment using Likert-scale satisfaction questionnaires (scale in 5 point scale) minimum : 1 Strongly disagree (worse outcome) maximum : 5 Strongly agree (better outcome)

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

    Time frame: Baseline

    correlation scores with a significant level of the correlation coefficient (r > 0.7)

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

    Time frame: Baseline and Day 15

    median (IQR) scores in the different alternative diagnoses

Study contacts

Contact information is provided by the study sponsor or research team.

Lydia FLAUX, Medical Doctor

CONTACT

[email protected]

+33 (0)2.41.35.44.10

Matthieu LE LAY

CONTACT

[email protected]

+33 (0)2 41 35 58 91

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: TACTILE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.