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Safety of Thoracoscopy in Patients With High Risk

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Muzaffer Metintas, Eskisehir Osmangazi University
ClinicalTrials.gov Identifier:
NCT01193439
First received: August 26, 2010
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition
Pleural Diseases

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Safety of Thoracoscopy in Patients With High Risk

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eskisehir Osmangazi University:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 355
Study Start Date: January 2002
Study Completion Date: December 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with high risk
Patients in normal conditions

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who require thoracoscpic investigation

Criteria

Inclusion Criteria:

  • Patients with exudative pleural effusion

Exclusion Criteria:

  • Patients without pleural effusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193439

Locations
Turkey
ESOGU
Eskisehir, Turkey
Sponsors and Collaborators
Eskisehir Osmangazi University
Investigators
Principal Investigator: Muzaffer Metintas, Professor Head of Department, Professor of pulmonary medicine
  More Information

Publications:

Responsible Party: Muzaffer Metintas, MD, Eskisehir Osmangazi University
ClinicalTrials.gov Identifier: NCT01193439     History of Changes
Other Study ID Numbers: 082010/1
Study First Received: August 26, 2010
Last Updated: September 24, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by Eskisehir Osmangazi University:
thoracoscopy
pleural diseases
complications
safety

Additional relevant MeSH terms:
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013