Clinical trial NCT04862494: Diaphragmatic Eventration in Children : Evaluation of Care Strategies and Results in the French Cohort.
Official title: Paediatric Treatment of Diaphragmatic Eventrations in France: Management Strategies and Long-term Results : an Observational Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diaphragmatic Eventration
Keywords: thoracoscopy
laparoscopy
digestive disorders
restrictive syndrom
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2021-04-28
Enrollment: 100
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criterion:

* Patients of 16 years of age and under at diagnosis with diaphragmatic eventration, treated since 2010 in a pediatric surgery care unit in France.

Exclusion Criterion:

* Patients with a diaphragmatic hernia
* Patient's parents or legual guardian opposed to being included in the study.

Primary outcomes:
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
Secondary outcomes:
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
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
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
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
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital of Angers
name: Guillaume Podevin, MD-PhD
role: STUDY_DIRECTOR
References: