Diaphragmatic Eventration in Children : Evaluation of Care Strategies and Results in the French Cohort.
NCT ID: NCT04862494
Last Updated: 2021-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2021-05-31
2022-06-30
Brief Summary
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Most 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.
Surgical 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.
When surgery is not indicated, follow up consists of regular clinical and radiological monitoring.
There 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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diaphragmatic eventation with medical surveillance
Patients with a diagnosis of diaphragmatic eventration without respiratory or digestive consequences, thus not requiring surgical repair.
clinical surveillance
regular clinical follow up including chest X-rays, pulmonary investigations, etc...
diaphragmatic eventration treated with plication
Patients with a diagnosis of diaphragmatic eventration with respiratory or digestive repercussion, requiring surgical repair.
diaphragmatic plication
plication of a hemidiaphragm, performed via laparoscopy, thoracoscopy (including robot-assisted surgery), or classical thoracotomy
Interventions
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clinical surveillance
regular clinical follow up including chest X-rays, pulmonary investigations, etc...
diaphragmatic plication
plication of a hemidiaphragm, performed via laparoscopy, thoracoscopy (including robot-assisted surgery), or classical thoracotomy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criterion:
* Patients with a diaphragmatic hernia
* Patient's parents or legual guardian opposed to being included in the study.
16 Years
ALL
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Principal Investigators
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Guillaume Podevin, MD-PhD
Role: STUDY_DIRECTOR
University Hospital of Angers
Central Contacts
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References
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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.
Other Identifiers
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2021-013
Identifier Type: -
Identifier Source: org_study_id
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