Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT04862494
Status:
UNKNOWN
Last Update Posted:
2021-04-28
First Post:
2021-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diaphragmatic Eventration in Children : Evaluation of Care Strategies and Results in the French Cohort.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003965', 'term': 'Diaphragmatic Eventration'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}], 'ancestors': [{'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-22', 'studyFirstSubmitDate': '2021-04-12', 'studyFirstSubmitQcDate': '2021-04-22', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the level of asymptomatic patients diagnosed with diaphragmatic eventration depending on the type of treatment (surgical or not).', 'timeFrame': 'Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age', 'description': 'Asymptomatic patient rate defined as patients presenting without any digestive, respiratory or orthopaedic symptom.'}], 'secondaryOutcomes': [{'measure': 'To assess the occurrence of lung disease in patients with non treated diaphragmatic eventrations', 'timeFrame': 'Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age', 'description': 'Objectified by pulmonary function tests (PFTs), carried out according to the ATS/ERS-GLI (American Thoracic Society and European Respiratory Society-Global Lung Initiative) recommendations.'}, {'measure': 'To assess the rate of digestive symptoms in patients with diaphragmatic eventrations.', 'timeFrame': 'Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age', 'description': 'Clinical assessment of digestive symptoms linked to diaphragmatic eventration and/or to diaphragmatic plication, such à GERD, dumping syndrom, digestive occlusion or pain (scored by visual analogic scale).'}, {'measure': 'To assess the occurrence of orthopaedic impact of non treated diaphragmatic eventrations', 'timeFrame': 'Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age', 'description': 'objectified by the deformation of the spine on chest x-ray measured by the Cobb angle.'}, {'measure': 'To assess the severity rate of postoperative complications', 'timeFrame': 'Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age', 'description': 'Description of postoperative complications encountered after diaphragmatic plication, scored with the Clavien-Dindo classification.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thoracoscopy', 'laparoscopy', 'digestive disorders', 'restrictive syndrom'], 'conditions': ['Diaphragmatic Eventration']}, 'referencesModule': {'references': [{'pmid': '39442326', 'type': 'DERIVED', 'citation': 'Heng L, Alzahrani K, Montalva L, Podevin G, Schmitt F; PedDiaVen collaboration group. Congenital Diaphragmatic Eventration: Should we Maintain Surgical Treatment? A Retrospective Multicentric Cohort Study. J Pediatr Surg. 2025 Jan;60(1):161991. doi: 10.1016/j.jpedsurg.2024.161991. Epub 2024 Oct 10.'}]}, 'descriptionModule': {'briefSummary': 'A diaphragmatic eventration is an abnormal and permanent elevation of a portion or an entire intact hemidiaphragm. This rare pathology, found in 0.2 - 1 for every 1000 patients in large radiological series, is either congenital or acquired due to phrenic nerve palsy.\n\nMost diaphragmatic eventrations are asymptomatic and discovered thanks to chest x-rays, where the diaphragmatic dome is elevated and visualized above the 4th intercostal space and sometimes up to the clavicle. Computed tomography or magnetic resonance imaging confirms the eventration by visualizing the diaphragmatic muscle distended and intact, unlike a diaphragmatic rupture or hernia.\n\nSurgical indications are usually due to respiratory disorders or visceral repercussions, such as gastric emptying disorders or acute accidents like gastric volvulus. Surgical treatment is a phrenic plication, which can be performed via a lateral thoracotomy (classical approach), thoracoscopy or laparoscopy.\n\nWhen surgery is not indicated, follow up consists of regular clinical and radiological monitoring.\n\nThere is, however, no consensus when it comes to their medical and surgical management due to the very low number of patients per center and per year, and the fact that very few studies specifically address this subject in the literature.', 'detailedDescription': 'This is a retrospective multicenter descriptive cohort study based on French national healthcare data. The aim of this study is to describe the current trends in management of diaphragmatic eventrations in France in order to indentify potential risk factors for complications and to improve and homogenize practices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'National cohort of all pediatric patients diagnosed with or operated for diaphragmatic eventration since January, 1st, 2010, in a pediatric surgical care unit in France. Patients will be devided into non operated and operated patients for outcome comparisons.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criterion:\n\n* Patients of 16 years of age and under at diagnosis with diaphragmatic eventration, treated since 2010 in a pediatric surgery care unit in France.\n\nExclusion Criterion:\n\n* Patients with a diaphragmatic hernia\n* Patient's parents or legual guardian opposed to being included in the study."}, 'identificationModule': {'nctId': 'NCT04862494', 'acronym': 'PedDiaVen', 'briefTitle': 'Diaphragmatic Eventration in Children : Evaluation of Care Strategies and Results in the French Cohort.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Paediatric Treatment of Diaphragmatic Eventrations in France: Management Strategies and Long-term Results : an Observational Study.', 'orgStudyIdInfo': {'id': '2021-013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'diaphragmatic eventation with medical surveillance', 'description': 'Patients with a diagnosis of diaphragmatic eventration without respiratory or digestive consequences, thus not requiring surgical repair.', 'interventionNames': ['Other: clinical surveillance']}, {'label': 'diaphragmatic eventration treated with plication', 'description': 'Patients with a diagnosis of diaphragmatic eventration with respiratory or digestive repercussion, requiring surgical repair.', 'interventionNames': ['Procedure: diaphragmatic plication']}], 'interventions': [{'name': 'clinical surveillance', 'type': 'OTHER', 'description': 'regular clinical follow up including chest X-rays, pulmonary investigations, etc...', 'armGroupLabels': ['diaphragmatic eventation with medical surveillance']}, {'name': 'diaphragmatic plication', 'type': 'PROCEDURE', 'description': 'plication of a hemidiaphragm, performed via laparoscopy, thoracoscopy (including robot-assisted surgery), or classical thoracotomy', 'armGroupLabels': ['diaphragmatic eventration treated with plication']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Françoise Schmitt, MD-PhD', 'role': 'CONTACT', 'email': 'FrSchmitt@chu-angers.fr', 'phone': '+33241354290'}], 'overallOfficials': [{'name': 'Guillaume Podevin, MD-PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital of Angers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}