Status:
COMPLETED
A Prospective Randomised Study of Efficacy, Safety and Costs of Talc Pleurodesis Under Medical Thoracoscopy and Pleurodesis Under Video-assisted Thoracoscopy Surgery for Recurrent Primary Spontaneous Pneumothorax
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Pneumothorax
Eligibility:
All Genders
15-55 years
Phase:
NA
Brief Summary
Treatment of recurrent primary spontaneous pneumothorax remains controversial and many therapeutic options exist. The aim of this study is to compare pleural symphysis by talc poudrage during medical ...
Detailed Description
Treatment of recurrent primary spontaneous pneumothorax remains controversial and many therapeutic options exist. What is the best technical option : treatment of the lung and the parietal pleura or t...
Eligibility Criteria
Inclusion
- Subjects :both sexes, who the age is included between 18 years and 55 years;
- Presenting a recurrence homolaterale or controlaterale of a primary spontaneous pneumothorax;
- Presenting a bilateral primary spontaneous pneumothorax
- Presenting a failure of a manual inhalation for a primary spontaneous pneumothorax;
- Presenting a persistent superior bullage at 48 am after a thoracic drainage for a spontaneous pneumothorax
- Presenting a persistent superior bullage at 48 am after a thoracic drainage for a primary spontaneous pneumothorax;
- Presenting a persistent superior unsticking at 48 am after a thoracic drainage for a primary spontaneous pneumothorax;
- Presenting a first episode of pneumothorax spontaneous primary with risk factor of recurrence
- The unsticking must be complete or important (superior to 3 cms between the summit of the lung and the summit of the thoracic cavity or superior to 2 cms with regard to the side thoracic wall);
- Benefiting from a national insurance scheme;
- Agreeing to participate in the study, and having read, included and signed the note of information intended in patients.
Exclusion
- Subjects:Presenting a traumatic pneumothorax; Presenting a pneumothorax iatrogène; Presenting a secondary spontaneous pneumothorax ( underlying pleuro-lung pathology); Presenting bubbles of emphysema of size(cutting) superior to 5 cms; presenting a pneumothorax catamenial;Presenting one of the following concomitant severe pathologies dissuading a general anesthetic or any symphysant gesture(movement): cardiac insufficiency
- Pregnant or breast-feeding Woman;
- presenting neurological disorders or psychiatric forbidding the understanding of the essay;
- Who the follow-up is impossible;
- Deprived of freedom following a court or administrative order;
- Not having signed the enlightened assent.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00767962
Start Date
February 1 2009
End Date
December 1 2014
Last Update
August 24 2015
Active Locations (1)
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1
Service d'Oncologie Thoracique- Hôpital Sainte Marguerite
Marseille, France, 13274