Evaluation of the Respiratory Impact After Conventional or Minimally Invasive Esophageal Atresia Surgery

Study Overview
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Brief Summary
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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).

Detailed Description
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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)

Official Title
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Evaluation of the Respiratory Impact of Post-operative Chest Wall Anomalies After Conventional or Minimally Invasive Esophageal Atresia Surgery

Conditions
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Esophageal Atresia, Oesophageal Atresia, Restrictive Lung Disease, Chest Wall Anomaly

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Long gap esophageal atresia Patients lost to follow up Deceased No PFTs or X-rays between 6 and 9 years of follow up Patients having had thoracic surgery before the esophageal atresia repair
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conventional surgery<br>Patients having had esophageal atresia (type III, long gap excluded) repair by conventional surgery (right thoracotomy) or patients having had minimally invasive surgery converted to thoracotomy between the 1st of january 2008 and the 31st of December 2013 and registered on the national esophageal atresia registry (CRACMO, Lille university hospital) | |
| Minimally invasive surgery<br>Patients having had esophageal atresia (type III, long gap excluded) repair through minimally invasive surgery between the 1st of january 2008 and the 31st of December 2013 and registered on the national esophageal atresia registry (CRACMO, Lille university hospital) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 6 to 9 years of age. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of restrictive lung disease | Depending on Z-score value | 6 to 9 years of age | 
| Assesse the occurrence of obstructive or mixed lung disease | Objectified by pulmonary function tests (PFTs), carried out according to the current national guidelines. Mixed lung disease defined by: FEV1/FVC ratio < -1.64 Z-score and CVF < -1.64 Z-score and obstructive lung disease | 6 to 9 years | 
| Mortality rate | Percentage of mortality in each group, cause of death linked directly to surgery or not | Time of surgery to 6 to 9 years consultation | 
| Percentage of post-operative complications depending on the type of surgery | Bleeding, infection, anastomotic stenosis, anastomotic leak | Time of surgery to 6 to 9 years consultation | 
| Chest wall anomalies detected on thoracic X-rays | Hemivertebra, rib fusion, intercostal abnormalities, scoliosis | 6 to 9 years of age | 
| Correlation between post-operative chest wall anomalies and restrictive lung disease | In each group, comparison of the percentage of chest wall anomalies detected on the X-rays and the percentage of restrictive lung disease cases | 6 to 9 years of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal atresia, thoracoscopy, rib fusion, scoliosis, Respiratory function