NCT04862494

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
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diaphragmatic Eventration

Interventions

Type	Name	Description
OTHER	clinical surveillance	regular clinical follow up including chest X-rays, pulmonary investigations, etc...
PROCEDURE	diaphragmatic plication	plication of a hemidiaphragm, performed via laparoscopy, thoracoscopy (including robot-assisted surgery), or classical thoracotomy

Timeline

• Start date: 2021-05-01
• Primary completion: 2021-12-01
• Completion: 2022-06-01
• First posted: 2021-04-28
• Last updated: 2021-04-28