Status:
UNKNOWN
Absorbable Mesh Pleurodesis in Thoracoscopic Treatment of Spontaneous Pneumothorax
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Science and Technology Council, Taiwan
Chang Gung Memorial Hospital
Conditions:
Spontaneous Pneumothorax
Surgery
Eligibility:
All Genders
15-50 years
Phase:
PHASE2
PHASE3
Brief Summary
Primary spontaneous pneumothorax usually occurs in young, lean male without underlying lung disease. In most cases, the cause of pneumothorax is rupture of blebs at the apex of the lung. Traditionally...
Detailed Description
Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males (1, 2). The estimated recurrence rate is 23-50% after the first episode and increases to 60% after the second pneumotho...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age between 15 and 50 years old.
- Spontaneous pneumothorax requiring thoracoscopic surgery.
- With written inform consent
- Exclusion criteria:
- With underlying pulmonary disease (chronic obstructive pulmonary disease, bronchiectasis, tuberculosis, etc)
- A history of previous ipsilateral thoracic operation
- Diagnosis of catamenial pneumothorax
- Diagnosis of lymphangioleiomyomatosis
- Concurrent hemopneumothorax with bleeding \> 500ml/h
- Pregnant or lactating women
- Other serious concomitant illness or medical conditions:
- Congestive heart failure or unstable angina pectoris.
- History of myocardial infarction within 1 year prior to the study entry.
- Uncontrolled hypertension or arrhythmia.
- History of significant neurologic or psychiatric disorders, including dementia or seizure.
- Active infection requiring i.v. antibiotics.
Exclusion
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT01848860
Start Date
May 1 2013
End Date
December 1 2018
Last Update
July 8 2015
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, Taiwan, 100