Improving Primary Spontaneous Pneumothorax (PSP) Treatment Techniques in VATS
NCT ID: NCT01463553
Last Updated: 2013-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
320 participants
INTERVENTIONAL
2011-07-31
2013-11-30
Brief Summary
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1. Evaluate the validity of using abnormal characteristics of the pneumothorax line, as evaluated from chest X-ray film, as the operative indications for video-assisted thoracic surgery (VATS) on primary spontaneous pneumothorax (PSP).
2. Through a randomized double blind controlled trial on patients whose PSP was caused by lung bullae, evaluate the effectiveness of pleurodesis in terms of the rate of recurrence of PSP and the trauma of the operation on patients.
3. Based on the findings, establish selection standards for the timing of surgery to treat PSP by VATS and establish technical specifications for performing operations on different types of lung bullae. The goal is to improve the diagnosis and treatment of PSP so as to reduce the recurrence rate of pneumothorax, reduce the trauma of operation, shorten hospital stays and postoperative recovery time, and provide better services for returning to everyday life and improving the quality of life for patients.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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wedge resection
No interventions assigned to this group
Wedge resection and pleurodosis
VATS pleurodesis
Based on the findings, establish selection standards for the timing of surgery to treat PSP by VATS and establish technical specifications for performing operations on different types of lung bullae. The goal is to improve the diagnosis and treatment of PSP so as to reduce the recurrence rate of pneumothorax, reduce the trauma of operation, shorten hospital stays and postoperative recovery time, and provide better services for returning to everyday life and improving the quality of life for patients.
Interventions
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VATS pleurodesis
Based on the findings, establish selection standards for the timing of surgery to treat PSP by VATS and establish technical specifications for performing operations on different types of lung bullae. The goal is to improve the diagnosis and treatment of PSP so as to reduce the recurrence rate of pneumothorax, reduce the trauma of operation, shorten hospital stays and postoperative recovery time, and provide better services for returning to everyday life and improving the quality of life for patients.
Eligibility Criteria
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Inclusion Criteria
2. patients whose lung compression exceeded 30% for the first incidence of pneumothorax
3. patients between the ages of 14 and 40, with normal vital signs (body temperature, breathing, blood pressure, pulse) and normal results on routine examination (routine blood test, liver and kidney functions)
4. no language barrier, such as surdimutism, aphasia
5. patients who voluntarily joined the group and signed the informed consent after reviewing the substance, significance and risks of this experiment
Exclusion Criteria
2. patients who refuse the follow-up
3. patients with secondary spontaneous pneumothorax including that caused by emphysema, COPD, asthma, pulmonary lymphangiomyomatosis, thoracic injury and other diseases
4. patients with mental illness, low IQ, or inability to understand the informed consent
5. substance abusers
10 Years
45 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
Beijing Haidian Hospital
OTHER
Responsible Party
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Huang Yuqing
Deputy Director
Principal Investigators
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Jun Liu, associate director
Role: PRINCIPAL_INVESTIGATOR
Peking University People Hospital
Locations
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Beijing Haidian Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xu Wang, Director
Role: primary
References
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Min X, Huang Y, Yang Y, Chen Y, Cui J, Wang C, Huang Y, Liu J, Wang J. Mechanical pleurodesis does not reduce recurrence of spontaneous pneumothorax: a randomized trial. Ann Thorac Surg. 2014 Nov;98(5):1790-6; discussion 1796. doi: 10.1016/j.athoracsur.2014.06.034. Epub 2014 Sep 16.
Other Identifiers
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Z111107058811089
Identifier Type: -
Identifier Source: org_study_id