Acute AppendicitisTACTILENCT07479849
TACTILE : Validation of a Teleconsultation-Based Predictive Score for the Diagnosis of Acute Appendicitis in Children Using Artificial Intelligence Methods
A study testing Score-based appendicitis risk classification in teleconsultation in people with Acute Appendicitis, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- Score-based appendicitis risk classification in teleconsultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Angers, University Hospital
Angers, 49000
Lydia FLAUX, Medical Doctor, +33 (0)2.41.35.44.10, Lydia.Flaux@chu-angers.fr
About this study
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.
Read the detailed 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.
- Conditions
- Acute Appendicitis
- Being tested
- Score-based appendicitis risk classification in teleconsultation
- Keywords
- telediagnosis, validation study, Pediatric medicine
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Score-based appendicitis risk classification in teleconsultationDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: Score-based appendicitis risk classification in teleconsultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and Day 15
Secondary outcomes (5)
Non-inferiority of the teleconsultation-based score compared with standard pediatric emergency consultation diagnosis
AUC non-inferiority margin of 0.1
Measured: Baseline and Day 15
Additional performance metrics of the predictive models
sensitivity, specificity, precision, recall, AUC-precision recall
Measured: Baseline and Day 15
Feasibility and acceptability of parent-assisted clinical examination
assessment using Likert-scale satisfaction questionnaires (scale in 5 point scale) minimum : 1 Strongly disagree (worse outcome) maximum : 5 Strongly agree (better outcome)
Measured: Baseline
Association between teleconsultation-based scores and clinical diagnosis probability assessed by the investigator
correlation scores with a significant level of the correlation coefficient (r > 0.7)
Measured: Baseline
Distribution of teleconsultation-based scores across alternative (non-appendicitis) diagnoses
median (IQR) scores in the different alternative diagnoses
Measured: Baseline and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lydia FLAUX, Medical Doctor, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479849
- Sponsor's protocol ID
- 49RC24_0251
- Other IDs
- 2025-A02854-45
- Acronym
- TACTILE
- Status last verified
- Mar 2026
- First submitted
- 9 Feb 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TACTILE : Validation of a Teleconsultation-Based Predictive Score for the Diagnosis of Acute Appendicitis in Children Using Artificial Intelligence Methods
- ClinicalTrials.gov ID
- NCT07479849
- Acronym / sponsor ID
- TACTILE / 49RC24_0251
- Conditions
- Acute Appendicitis
- Keywords
- telediagnosis, validation study, Pediatric medicine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High risk group of children according to diagnostic score of appendicitis | Other | Diagnostic Test: Score-based appendicitis risk classification in teleconsultationAfter diagnostic score assessment, children are assigned to the High risk group using computational technique from artificial intelligence then followed-up for 15 days |
| Low risk group of children according to diagnostic score of appendicitis | Other | Diagnostic Test: Score-based appendicitis risk classification in teleconsultationAfter diagnostic score assessment, children are assigned to the Low risk group using computational technique from artificial intelligence then followed-up for 15 days |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Score-based appendicitis risk classification in teleconsultationMedical 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 | Diagnostic test | High risk group of children according to diagnostic score of appendicitis, Low risk group of children according to diagnostic score of appendicitis |
Primary outcome
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)
5 secondary outcomes
Non-inferiority of the teleconsultation-based score compared with standard pediatric emergency consultation diagnosis
Time frame: Baseline and Day 15
Additional performance metrics of the predictive models
Time frame: Baseline and Day 15
Feasibility and acceptability of parent-assisted clinical examination
Time frame: Baseline
Association between teleconsultation-based scores and clinical diagnosis probability assessed by the investigator
Time frame: Baseline
Distribution of teleconsultation-based scores across alternative (non-appendicitis) diagnoses
Time frame: Baseline and Day 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lydia FLAUX, Medical Doctor principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Score-based appendicitis risk classification in teleconsultation in people with Acute Appendicitis, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lydia FLAUX, Medical Doctor (+33 (0)2.41.35.44.10, Lydia.Flaux@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of the teleconsultation-based appendicitis score (time frame: Baseline and Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.