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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
70
Pleuroscopy using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany
Pleuroscopy using a semirigid thoracoscope model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan
Postgraduate Institute of Medical Education and Research
Chandigarh, Chandigarh, India
Diagnostic yield of thoracoscopic biopsy by intention to treat analysis
The proportion of patients where thoracoscopic pleural biopsy yielded a diagnosis that was consistent with the present clinical picture and the further follow-up of the patients, would be calculated and compared between the two arms
Time frame: 3 months
Yield of biopsies successfully completed
The diagnostic yield of only those procedures would be considered separately where a biopsy could be successfully done and compared between the two arms
Time frame: 3 months
Complications
Number of major and minor complications encountered in the two arms
Time frame: 3 months
Scar size
Scar size (in mm) in the longest axis
Time frame: At the end of the procedure
Biopsy size
Biopsy size (in mm) in the longest axis
Time frame: At the end of the procedure
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