Chest Tube Drainage or Thoracoscopic Surgery for Failed Aspiration of Spontaneous Pneumothorax
Comparison of Chest Tube Drainage Versus Thoracoscopic Surgery for Unsuccessful Aspiration of Primary Spontaneous Pneumothorax: a Prospective Randomized Trial
1 other identifier
interventional
60
1 country
2
Brief Summary
We hypothesize that VATS is more effective than CTD for management of primary spontaneous pneumothorax with aspiration failure. To this end, we will compare two groups of patients who had experienced unsuccessful aspiration of primary spontaneous pneumothorax stratified by treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2008
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 9, 2008
CompletedFirst Posted
Study publicly available on registry
July 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedDecember 17, 2012
November 1, 2012
4.6 years
July 9, 2008
December 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparing the number of days in hospital, after intervention, of each group.
within one month
Secondary Outcomes (3)
Short-term outcome, including number of days with chest drainage, total hospital stay, short-term failure rate of assigned treatment, adverse events, pain score, mean dose of meperidine requested.
within one month
Long-term outcome, including recurrence rate and long-term failure rate of assigned treatment
2 years
Total costs of each patients in assigned treatment.
2 years
Study Arms (2)
1
ACTIVE COMPARATORSurgery: Video-assisted thoracoscopic surgery
2
ACTIVE COMPARATORChest tube drainage
Interventions
Eligibility Criteria
You may qualify if:
- Age between 15 and 50 years old.
- First episode of spontaneous pneumothorax.
- The rim of air is \> 2cm on CXR requiring simple aspiration
- Aspiration as the initial treatment
- Failed to achieve lung expansion following repeat manual aspiration
You may not qualify if:
- Complete or nearly complete and persistent lung expansion immediately following manual aspiration
- With underlying pulmonary disease (TB, asthma, etc)
- With hemothorax or tension pneumothorax requiring chest tube insertion or operation
- A history of previous pneumothorax
- A history of previous ipsilateral thoracic operation
- Pregnant or lactation female
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
National Taiwan University Hospital
Taipei, 100, Taiwan
Far Eastern Memorial Hospital
Taipei County, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yung-Chie Lee, MD, PhD
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2008
First Posted
July 11, 2008
Study Start
April 1, 2008
Primary Completion
November 1, 2012
Study Completion
September 1, 2013
Last Updated
December 17, 2012
Record last verified: 2012-11