An interventional study of Score-based appendicitis risk classification in teleconsultation in Acute Appendicitis, sponsored by University Hospital, Angers. Not yet recruiting at 1 site in France. Open to participants aged 3 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by University Hospital, Angers · Not applicable, Interventional, and Diagnostic
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.
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.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 111 across 252 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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)
Time frame: Baseline and Day 15
Non-inferiority of the teleconsultation-based score compared with standard pediatric emergency consultation diagnosis
AUC non-inferiority margin of 0.1
Time frame: Baseline and Day 15
Additional performance metrics of the predictive models
sensitivity, specificity, precision, recall, AUC-precision recall
Time frame: 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)
Time frame: 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)
Time frame: Baseline
Distribution of teleconsultation-based scores across alternative (non-appendicitis) diagnoses
median (IQR) scores in the different alternative diagnoses
Time frame: Baseline and Day 15
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Jun 2029, 36 months later.
Of 89 non-industry interventional studies with no phase under Appendicitis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's planned 36 months is above that.
Counting every sponsor, half of 91 studies reached it within 18 months; a quarter within 10 and three quarters within 36.
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This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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