Clinical Trial: 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 Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

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

Detailed Summary: 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.
Sponsor: Assistance Publique Hopitaux De Marseille

Current Primary Outcome: to show the non-inferiority of talc pleurodesis under medical thoracoscopy versus pleurodesis under video-assisted thoracoscopy surgery for recurrent primary spontaneous pneumothorax [ Time Frame: 36 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Assistance Publique Hopitaux De Marseille

Dates:
Date Received: October 6, 2008
Date Started: February 2009
Date Completion:
Last Updated: August 21, 2015
Last Verified: August 2015