Diaphragmatic Eventration Clinical Trial
— PedDiaVenOfficial title:
Paediatric Treatment of Diaphragmatic Eventrations in France: Management Strategies and Long-term Results : an Observational Study.
| NCT number | NCT04862494 |
| Other study ID # | 2021-013 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 2021 |
| Est. completion date | June 2022 |
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.
| Status | Not yet recruiting |
| Enrollment | 100 |
| Est. completion date | June 2022 |
| Est. primary completion date | December 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 16 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Angers |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To assess the level of asymptomatic patients diagnosed with diaphragmatic eventration depending on the type of treatment (surgical or not). | Asymptomatic patient rate defined as patients presenting without any digestive, respiratory or orthopaedic symptom. | 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 | To assess the occurrence of lung disease in patients with non treated diaphragmatic eventrations | Objectified by pulmonary function tests (PFTs), carried out according to the ATS/ERS-GLI (American Thoracic Society and European Respiratory Society-Global Lung Initiative) recommendations. | 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 | To assess the rate of digestive symptoms in patients with diaphragmatic eventrations. | Clinical 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). | 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 | To assess the occurrence of orthopaedic impact of non treated diaphragmatic eventrations | objectified by the deformation of the spine on chest x-ray measured by the Cobb angle. | 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 | To assess the severity rate of postoperative complications | Description of postoperative complications encountered after diaphragmatic plication, scored with the Clavien-Dindo classification. | 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 |