An observational study in Diaphragmatic Eventration, sponsored by University Hospital, Angers. Status unknown. Open to participants aged Up to 16 Years. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by University Hospital, Angers · Observational
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.
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.
406 studies on the registry are indexed under Digestive System Diseases; 79 are open to participants now.
This study's planned enrollment of 100 is below the median of 400 across 105 observational studies indexed under Digestive System Diseases.
Browse Digestive System Diseases studies →University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criterion:
Patients with a diagnosis of diaphragmatic eventration without respiratory or digestive consequences, thus not requiring surgical repair.
Other: clinical surveillance
Patients with a diagnosis of diaphragmatic eventration with respiratory or digestive repercussion, requiring surgical repair.
Procedure: diaphragmatic plication
regular clinical follow up including chest X-rays, pulmonary investigations, etc...
plication of a hemidiaphragm, performed via laparoscopy, thoracoscopy (including robot-assisted surgery), or classical thoracotomy
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.
Time frame: 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
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.
Time frame: 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
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).
Time frame: 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
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.
Time frame: 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
To assess the severity rate of postoperative complications
Description of postoperative complications encountered after diaphragmatic plication, scored with the Clavien-Dindo classification.
Time frame: 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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2021; primary completion for Dec 2021, 7 months later.
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This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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