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

Study Overview
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Brief Summary
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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 thoracoscopy and surgical management combining pleural abrasion and blebs or bullae resection for treatment of recurrent primary spontaneous pneumothorax.

Detailed Description
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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 treatment of the pleura with pleural symphysis ? Talc pleurodesis performed during medical thoracoscopy and resection of blebs or bullae associated with pleural abrasion during surgical thoracoscopy (or video-assisted thoracic surgery) are the most usual methods. These two procedures have never been compared in a prospective trial. The aim of this study is to compare pleural symphysis by talc poudrage during medical thoracoscopy and surgical management combining pleural abrasion and blebs or bullae resection for treatment of recurrent primary spontaneous pneumothorax.

Official Title
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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

Conditions
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Pneumothorax

Intervention / Treatment
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* Other: talc pleurodesis under medical thoracoscopy
* Other: pleurodesis under video-assisted thoracoscopy surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: Subjects:Presenting a traumatic pneumothorax; Presenting a pneumothorax iatrogÃƒÂ¨ne; 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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 55 Years

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>talc pleurodesis under medical thoracoscopy | Other: talc pleurodesis under medical thoracoscopy<br>* talc pleurodesis under medical thoracoscopy for recurrent primary spontaneous pneumothorax<br>|
| Other: 2<br>pleurodesis under video-assisted thoracoscopy surgery | Other: pleurodesis under video-assisted thoracoscopy surgery<br>* pleurodesis under video-assisted thoracoscopy surgery for recurrent primary spontaneous pneumothorax<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to show the non-inferiority of talc pleurodesis under medical thoracoscopy versus pleurodesis under video-assisted thoracoscopy surgery for recurrent primary spontaneous pneumothorax |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent primary spontaneous pneumothorax