Clincosm LogoSign in Get a demo

Safety of Thoracoscopy in Patients With High Risk

Sponsor
Eskisehir Osmangazi University (Other)
Overall Status
Completed
CT.gov ID
NCT01193439
Collaborator
(none)
355
Enrollment
1
Location
107
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    355 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Safety of Thoracoscopy in Patients With High Risk
    Study Start Date :
    Jan 1, 2002
    Actual Primary Completion Date :
    Jan 1, 2009
    Actual Study Completion Date :
    Dec 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with high risk
    Patients in normal conditions

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [6 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with exudative pleural effusion
    Exclusion Criteria:
    • Patients without pleural effusion

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ESOGU Eskisehir Turkey

    Sponsors and Collaborators

    • Eskisehir Osmangazi University

    Investigators

    • Principal Investigator: Muzaffer Metintas, Professor, Head of Department, Professor of pulmonary medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Muzaffer Metintas, MD, Eskisehir Osmangazi University
    ClinicalTrials.gov Identifier:
    NCT01193439
    Other Study ID Numbers:
    • 082010/1
    First Posted:
    Sep 2, 2010
    Last Update Posted:
    Sep 25, 2012
    Last Verified:
    Sep 1, 2012
    Keywords provided by Muzaffer Metintas, MD, Eskisehir Osmangazi University
    thoracoscopy
    pleural diseases
    complications
    safety
    Additional relevant MeSH terms:
    Pleural Diseases

    Study Results

    No Results Posted as of Sep 25, 2012