Clinical Trial: A Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized Controlled Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions
Brief Summary: Rigid thoracoscopy is an established procedure for the performance of pleural biopsies for undiagnosed pleural effusions. The semirigid thoracoscope is a relatively new instrument designed for the same purpose which is claimed to be more user-friendly. The two devices have not been compared in a head-to-head trial in published literature. The investigators attempt to conduct a randomised comparative trial between the two devices.
Detailed Summary:
Sponsor: Postgraduate Institute of Medical Education and Research
Current Primary Outcome: Diagnostic yield of thoracoscopic biopsy by intention to treat analysis [ Time Frame: 3 months ]
Original Primary Outcome: Diagnostic yield of thoracoscopic biopsy by intention to treat analysis [ Time Frame: 20 months ]
Current Secondary Outcome:
- Yield of biopsies successfully completed [ Time Frame: 3 months ]The diagnostic yield of only those procedures would be considered separately where a biopsy could be successfully done and compared between the two arms
- Complications [ Time Frame: 3 months ]Number of major and minor complications encountered in the two arms
- Scar size [ Time Frame: At the end of the procedure ]Scar size (in mm) in the longest axis
- Biopsy size [ Time Frame: At the end of the procedure ]Biopsy size (in mm) in the longest axis
Original Secondary Outcome: Yield of biopsies successfully completed [ Time Frame: 20 months ]
Information By: Postgraduate Institute of Medical Education and Research
Dates:
Date Received: November 7, 2012
Date Started: April 2011
Date Completion:
Last Updated: January 9, 2013
Last Verified: January 2013