Evaluation of the Respiratory Impact After Conventional or Minimally Invasive Esophageal Atresia Surgery
NCT ID: NCT04136795
Last Updated: 2019-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2020-01-01
2020-12-31
Brief Summary
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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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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)
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Conventional surgery
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)
No interventions assigned to this group
Minimally invasive surgery
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)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Operation for type III esophageal atresia (Ladd classification)
* Between 01/01/2008 and 31/12/2013.
Exclusion Criteria
* 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
ALL
No
Sponsors
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Institut de Recherche en Santé, Environnement et le Travail, France
OTHER
Filière des Maladies Rares Abdomino-THOraciques : FIMATHO
UNKNOWN
University Hospital, Angers
OTHER_GOV
Responsible Party
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DENISE JOLIVOT
Dr Françoise Schmitt
Principal Investigators
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Françoise Schmitt, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Angers
Locations
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CRACMO - centre de référence des atrésies de l'oesophage
Lille, , France
Countries
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Central Contacts
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Facility Contacts
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Rony Sfeir, MD
Role: primary
References
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Bastard F, Bonnard A, Rousseau V, Gelas T, Michaud L, Irtan S, Piolat C, Ranke-Chretien A, Becmeur F, Dariel A, Lamireau T, Petit T, Fouquet V, Le Mandat A, Lefebvre F, Allal H, Borgnon J, Boubnova J, Habonimana E, Panait N, Buisson P, Margaryan M, Michel JL, Gaudin J, Lardy H, Auber F, Borderon C, De Vries P, Jaby O, Fourcade L, Lecompte JF, Tolg C, Delorme B, Schmitt F, Podevin G. Thoracic skeletal anomalies following surgical treatment of esophageal atresia. Lessons from a national cohort. J Pediatr Surg. 2018 Apr;53(4):605-609. doi: 10.1016/j.jpedsurg.2017.07.013. Epub 2017 Jul 21.
Other Identifiers
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49RC19_0185
Identifier Type: -
Identifier Source: org_study_id