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Chest Tube Drainage or Thoracoscopic Surgery for Failed Aspiration of Spontaneous Pneumothorax

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00713362
Recruitment Status : Unknown
Verified November 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : July 11, 2008
Last Update Posted : December 17, 2012
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Pneumothorax Procedure: Video-assisted thoracoscopic surgery Procedure: chest tube drainage Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Chest Tube Drainage Versus Thoracoscopic Surgery for Unsuccessful Aspiration of Primary Spontaneous Pneumothorax: a Prospective Randomized Trial
Study Start Date : April 2008
Actual Primary Completion Date : November 2012
Estimated Study Completion Date : September 2013

Arm Intervention/treatment
Active Comparator: 1
Surgery: Video-assisted thoracoscopic surgery
Procedure: Video-assisted thoracoscopic surgery
VATS for bullectomy and mechanical pleurodesis

Active Comparator: 2
Chest tube drainage
Procedure: chest tube drainage
Chest tube drainage for pneumothroax

Primary Outcome Measures :
  1. Comparing the number of days in hospital, after intervention, of each group. [ Time Frame: within one month ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: within one month ]
  2. Long-term outcome, including recurrence rate and long-term failure rate of assigned treatment [ Time Frame: 2 years ]
  3. Total costs of each patients in assigned treatment. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age between 15 and 50 years old.
  2. First episode of spontaneous pneumothorax.
  3. The rim of air is > 2cm on CXR requiring simple aspiration
  4. Aspiration as the initial treatment
  5. Failed to achieve lung expansion following repeat manual aspiration

Exclusion Criteria:

  1. Complete or nearly complete and persistent lung expansion immediately following manual aspiration
  2. With underlying pulmonary disease (TB, asthma, etc)
  3. With hemothorax or tension pneumothorax requiring chest tube insertion or operation
  4. A history of previous pneumothorax
  5. A history of previous ipsilateral thoracic operation
  6. Pregnant or lactation female

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00713362

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Contact: Jin-Shing Chen, MD.,PhD 886-2-23123456 ext 65178

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Far Eastern Memorial Hospital Recruiting
Taipei county, Taiwan
Contact: Kung-Tsao Tsai, MD    886-917925017   
Principal Investigator: Kung-Tsao Tsai, MD         
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Jin-Shing Chen, MD, PhD    886-2-23123456 ext 5178   
Principal Investigator: Jin-Shing Chen, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Department of Health, Executive Yuan, R.O.C. (Taiwan)
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Study Chair: Yung-Chie Lee, MD, PhD National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital Identifier: NCT00713362    
Other Study ID Numbers: 200801030R
First Posted: July 11, 2008    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: November 2012
Keywords provided by National Taiwan University Hospital:
Aspiration, chest tube, pneumothorax, thoracoscopic surgery
Additional relevant MeSH terms:
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Pleural Diseases
Respiratory Tract Diseases