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

NCT04136795 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2019-12-20

No results posted yet for this study

Summary

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).

Conditions

  • Esophageal Atresia
  • Oesophageal Atresia
  • Restrictive Lung Disease
  • Chest Wall Anomaly

Sponsors & Collaborators

  • Institut de Recherche en Santé, Environnement et le Travail, France

    collaborator OTHER

  • Filière des Maladies Rares Abdomino-THOraciques : FIMATHO

    collaborator UNKNOWN

  • University Hospital, Angers

    lead OTHER_GOV

Principal Investigators

  • Françoise Schmitt, MD, PhD · University Hospital of Angers

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2020-08-31
Completion
2020-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04136795 on ClinicalTrials.gov