Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT04885335
Status:
UNKNOWN
Last Update Posted:
2021-05-13
First Post:
2021-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Management of Acute Appendicitis Before Emergency Department in Children: a Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 11}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-09', 'studyFirstSubmitDate': '2021-05-09', 'studyFirstSubmitQcDate': '2021-05-09', 'lastUpdatePostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PAS score', 'timeFrame': 'At 5 month', 'description': 'Score ≤ 5: appendicitis unlikely. Score ≥ 6: probable appendicitis. Score ≥ 7: very probable appendicitis'}], 'secondaryOutcomes': [{'measure': 'Surgery for appendicitis', 'timeFrame': 'At 5 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Appendicitis']}, 'referencesModule': {'references': [{'pmid': '38373918', 'type': 'DERIVED', 'citation': 'Vevaud K, Dallocchio A, Dumoitier N, Laspougeas A, Labrunie A, Belgacem A, Fourcade L, Ballouhey Q. A prospective study to evaluate the contribution of the pediatric appendicitis score in the decision process. BMC Pediatr. 2024 Feb 19;24(1):131. doi: 10.1186/s12887-024-04619-z.'}]}, 'descriptionModule': {'briefSummary': 'Acute appendicitis is the first visceral surgical emergency in pediatrics with about 30,000 cases in children having been described in France.\n\nIt concerns 0.3% of children under 15 with a maximum frequency between 8 and 13 years of age. Acute appendicitis has a significant morbidity rate of 8% and a mortality rate under 0.1%.\n\n10 to 25% of the children admitted to emergency rooms for abdominal pain have appendicitis.\n\nIn 20 to 30% of the cases, the initial symptoms are atypical, which explains the difficulty in diagnosing.\n\nThe purpose of our study is to evaluate the quality of general practitioners in the diagnosis of acute appendicitis, its severity and the diagnostic criteria used.\n\nFurthermore, it is not as easy to evaluate pain or examine a complaint in children as it is in adults.\n\nAppendicectomy is the treatment of choice for all acute appendicitis. The importance of early diagnosis and treatment is, therefore, essential. Many predictive diagnostic scores have been studied over the years. The Pediatric Appendicitis Score (PAS) using typical symptoms of acute appendicitis and biological items was published in 2002. Nowadays, it is still considered as a reference and has been validated by other studies.\n\nMost of the patients suffering from abdominal pain first consult their general practitioner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '-Child \\<16 years with abdominal symptoms and consulting in the pediatric emergency department of Limoges University center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child \\<16 years\n* abdominal symptoms\n* consulting in the pediatric emergency department of Limoges University center.\n\nExclusion Criteria:\n\n* Child \\>=16 years'}, 'identificationModule': {'nctId': 'NCT04885335', 'briefTitle': 'Evaluation of the Management of Acute Appendicitis Before Emergency Department in Children: a Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'Evaluation of the Management of Acute Appendicitis Before Emergency Department in Children: a Prospective Study', 'orgStudyIdInfo': {'id': 'BAlouhhey_appendicites'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PAS (Pediatric Appendicitis Score) survey', 'type': 'OTHER', 'description': 'Score ≤ 5: appendicitis unlikely. Score ≥ 6: probable appendicitis. core ≥ 7: very probable appendicitis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '87000', 'city': 'Limoges', 'country': 'France', 'contacts': [{'name': 'Quentin Ballouhey, MD', 'role': 'CONTACT', 'email': 'quentin.ballouhey@unilim.fr'}], 'facility': 'Pediatric emergency department', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}], 'centralContacts': [{'name': 'Quentin Ballouhey, MD', 'role': 'CONTACT', 'email': 'quentin.ballouhey@unilim.fr', 'phone': '0555049027'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}