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

University Hospital, Angers

Status: Unknown

Conditions: Diaphragmatic Eventration

Treatments: Procedure: diaphragmatic plication; Other: clinical surveillance

Study type: Observational

Funder types: Other

Identifiers

NCT04862494

2021-013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

100 participants in 2 patient groups

diaphragmatic eventation with medical surveillance

Description:

Patients with a diagnosis of diaphragmatic eventration without respiratory or digestive consequences, thus not requiring surgical repair.

Treatment:

Other: clinical surveillance

diaphragmatic eventration treated with plication

Description:

Patients with a diagnosis of diaphragmatic eventration with respiratory or digestive repercussion, requiring surgical repair.

Treatment:

Procedure: diaphragmatic plication