Esophageal Atresia Clinical Trial
Official title:
Evaluation of the Respiratory Impact of Post-operative Chest Wall Anomalies After Conventional or Minimally Invasive Esophageal Atresia Surgery
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).
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.
All the patients included in the national esophageal atresia registry (CRACMO) having had an
operation for type III esophageal atresia (long gap esophageal atresia excluded), as defined
by the Ladd Classification, will be included in this study.
The exclusion criterion will be patients lost to follow up or deceased, patients having had
no pulmonary function tests (PFTs) or no thoracic X-Ray during the first 6 to 9 years of
follow up and patients having had thoracic surgery before the esophageal atresia repair.
The number of patients expected in the national esophageal atresia registry over the 6 years
excedes 500. The number of thoracoscopy repairs should be about 50.
This study should allow us to determine if minimally invasive surgery is beneficial on
mid-term respiratory function in children, related to possible post-operative chest wall
sequelae.
The results obtained from this study should lead to recommendations concerning the surgical
approach to esophageal atresia repair to improve the prognosis of chest wall anomalies and
respiratory function in these patients. It should also help to identify patient subgroups
which would benefit from a reinforced respiratory follow up. This could then lead to a
hospital clinical research program (PHRC)
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