Unknown statusInterventionalPhase 4Updated Nov 13, 2013
Improving Primary Spontaneous Pneumothorax (PSP) Treatment Techniques in VATS
ClinicalTrials.gov ID
NCT01463553
Lead Sponsor
Beijing Haidian HospitalOTHER
Overall Status
Unknown status
Study Type
Interventional
Phase
Phase 4
Enrollment
320Estimated
Last Update Posted
Nov 13, 2013Estimated
Start Date
Jul 2011
Primary Completion Date
Nov 2013Estimated
Completion Date
Nov 2013Estimated
Brief Summary
The purpose of this study is to:
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).
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.
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.
Pneumothorax
Pleurodesis
VATS pleurodesis
Ages Eligible for Study
Child (0-17)Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients in whom obvious bullous forms are seen in PSP pneumothorax lines, or whose pneumothorax lines are rough and interrupted with or without thoracentesis, thoracic close drainage
patients whose lung compression exceeded 30% for the first incidence of pneumothorax
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)
no language barrier, such as surdimutism, aphasia
patients who voluntarily joined the group and signed the informed consent after reviewing the substance, significance and risks of this experiment
Exclusion Criteria:
patients who refuse VATS operation
patients who refuse the follow-up
patients with secondary spontaneous pneumothorax including that caused by emphysema, COPD, asthma, pulmonary lymphangiomyomatosis, thoracic injury and other diseases
patients with mental illness, low IQ, or inability to understand the informed consent