Skip to content

Diaphragmatic Eventration in Children : Evaluation of Care Strategies and Results in the French Cohort.

Paediatric Treatment of Diaphragmatic Eventrations in France: Management Strategies and Long-term Results : an Observational Study.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04862494
Acronym
PedDiaVen
Enrollment
100
Registered
2021-04-28
Start date
2021-05-31
Completion date
2022-06-30
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragmatic Eventration

Keywords

thoracoscopy, laparoscopy, digestive disorders, restrictive syndrom

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.

Interventions

regular clinical follow up including chest X-rays, pulmonary investigations, etc...

PROCEDUREdiaphragmatic plication

plication of a hemidiaphragm, performed via laparoscopy, thoracoscopy (including robot-assisted surgery), or classical thoracotomy

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
To assess the level of asymptomatic patients diagnosed with diaphragmatic eventration depending on the type of treatment (surgical or not).Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of ageAsymptomatic patient rate defined as patients presenting without any digestive, respiratory or orthopaedic symptom.

Secondary

MeasureTime frameDescription
To assess the occurrence of lung disease in patients with non treated diaphragmatic eventrationsUp to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of ageObjectified by pulmonary function tests (PFTs), carried out according to the ATS/ERS-GLI (American Thoracic Society and European Respiratory Society-Global Lung Initiative) recommendations.
To assess the rate of digestive symptoms in patients with diaphragmatic eventrations.Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of ageClinical 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).
To assess the occurrence of orthopaedic impact of non treated diaphragmatic eventrationsUp to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of ageobjectified by the deformation of the spine on chest x-ray measured by the Cobb angle.
To assess the severity rate of postoperative complicationsUp to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of ageDescription of postoperative complications encountered after diaphragmatic plication, scored with the Clavien-Dindo classification.

Contacts

Primary ContactFrançoise Schmitt, MD-PhD
FrSchmitt@chu-angers.fr+33241354290

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026