Evaluation of the Respiratory Impact of Post-operative Chest Wall Anomalies After Conventional or Minimally Invasive Esophageal Atresia Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- To assess the occurrence of restrictive lung disease in patients with type III esophageal atresia depending on the type of surgical approach (Conventional or minimally invasive).
研究概览
简要总结
Right thoracotomy, conventional approach to esophageal atresia repair, leads to up to 60% radiological chest wall sequelae anomalies. The impact of these anomalies on the patient's respiratory function remains unknown. Minimally invasive thoracic surgery considerably reduces this rate.
The primary objective of this study is to assess the occurrence of restrictive lung disease in patients with type III esophageal atresia depending on the type of surgical approach (Conventional or minimally invasive).
The primary endpoint will be he occurrence of restrictive lung disease , objectified by pulmonary function tests (PFTs), carried out according to the current national guidelines (PNDS = protocole national de diagnostic et de soins).
详细描述
Right thoracotomy, conventional approach to esophageal atresia repair, leads to up to 60% radiological chest wall sequelae anomalies. The impact of these anomalies on the patient's respiratory function remains unknown. Minimally invasive thoracic surgery considerably reduces this rate.
The primary objective of this study is to assess the occurrence of restrictive lung disease in patients with type III esophageal atresia depending on the type of surgical approach (Conventional or minimally invasive).
The primary endpoint will be the occurrence of restrictive lung disease, as assessed by pulmonary function tests (PFTs), carried out according to the current national guidelines (PNDS = protocole national de diagnostic et de soins).
The secondary endpoints will be to measure the severity of the restrictive disease, to look for other respiratory alterations, to correlate radiological chest wall sequelae anomalies with the impact on respiratory function and to look for a causal relationship between the surgical technique used and the respiratory impact.
The methodology used will be a retrospective non interventional study on the cohort of patients included in the national esophageal atresia registry (CRACMO, Lille University Hospital) between the 1st of january 2008 and the 31st of December 2013.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients included in the national esophageal atresia registry (CRACMO)
- •Operation for type III esophageal atresia (Ladd classification)
- •Between 01/01/2008 and 31/12/2013.
排除标准
- •Long gap esophageal atresia
- •Patients lost to follow up
- •No PFTs or X-rays between 6 and 9 years of follow up
- •Patients having had thoracic surgery before the esophageal atresia repair
结局指标
主要结局
To assess the occurrence of restrictive lung disease in patients with type III esophageal atresia depending on the type of surgical approach (Conventional or minimally invasive).
时间窗: 6 to 9 years of age.
Objectified by pulmonary function tests (PFTs), carried out according to the current national guidelines. Restrictive lung disease defined by: FEV1/FVC ratio \> -1.64 Z-score and CVF \< -1.64 Z-score according to ATS/ERS-GLI (American Thoracic Society \& European Respiratory Society - Global Lungs Initiative) recommendations.
次要结局
- Percentage of post-operative complications depending on the type of surgery(Time of surgery to 6 to 9 years consultation)
- Severity of restrictive lung disease(6 to 9 years of age)
- Assesse the occurrence of obstructive or mixed lung disease(6 to 9 years)
- Mortality rate(Time of surgery to 6 to 9 years consultation)
- Chest wall anomalies detected on thoracic X-rays(6 to 9 years of age)
- Correlation between post-operative chest wall anomalies and restrictive lung disease(6 to 9 years of age)
研究者
DENISE JOLIVOT
Dr Françoise Schmitt
University Hospital, Angers