Paediatric Treatment of Diaphragmatic Eventrations in France: Management Strategies and Long-term Results : an Observational Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- To assess the level of asymptomatic patients diagnosed with diaphragmatic eventration depending on the type of treatment (surgical or not).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
To assess the level of asymptomatic patients diagnosed with diaphragmatic eventration depending on the type of treatment (surgical or not).
时间窗: 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
Asymptomatic patient rate defined as patients presenting without any digestive, respiratory or orthopaedic symptom.
次要结局
- 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 age)
- To assess the occurrence of lung disease in patients with non treated 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 age)
- To assess the occurrence of orthopaedic impact of non treated 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 age)
- To assess the severity rate of postoperative complications(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)