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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01193439
Other study ID # 082010/1
Secondary ID
Status Completed
Phase N/A
First received August 26, 2010
Last updated September 24, 2012
Start date January 2002
Est. completion date December 2010

Study information

Verified date September 2012
Source Eskisehir Osmangazi University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Observational

Clinical Trial Summary

Medical thoracoscopy can be performed for diagnostic as well as therapeutic purposes. Thoracoscopy in the diagnosis of pleural diseases is highly sensitive for detecting pleural neoplasia with negative pleural fluid cytology and in the diagnosis of tuberculosis. The indication of thoracoscopy in patients with pleural effusion has been optimized. In some studies medical thoracoscopy has been claimed a useful diagnostic tool with a very low rate of complications. However the investigators do not know its safety on high risk patients. Because many patients having suspected malignancy have bed conditions due to other health problems such as coronary heart diseases, COPD, arrythmia, hypoxemia. In this study the investigators aimed to test the safety of medical thoracoscopy in the patients with high risk for complications.


Recruitment information / eligibility

Status Completed
Enrollment 355
Est. completion date December 2010
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 85 Years
Eligibility Inclusion Criteria:

- Patients with exudative pleural effusion

Exclusion Criteria:

- Patients without pleural effusion

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey ESOGU Eskisehir

Sponsors (1)

Lead Sponsor Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Rodríguez-Panadero F. Medical thoracoscopy. Respiration. 2008;76(4):363-72. doi: 10.1159/000158545. Epub 2008 Nov 12. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events as a Measure of Safety and Tolerability All participants will have been followed for side effects of medical thoracoscopy. All side effects established in the special forms designed for this study. Side effects measured and recorded according to each characteristic such as pain, air leakege, pneumothorax, empyema, local infection, haemorragy etc. 6 years Yes
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