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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00713362
First received: July 9, 2008
Last updated: December 13, 2012
Last verified: November 2012
  Purpose
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 Intervention Phase
Pneumothorax Procedure: Video-assisted thoracoscopic surgery Procedure: chest tube drainage Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

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

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

Estimated Enrollment: 60
Study Start Date: April 2008
Estimated Study Completion Date: September 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713362

Contacts
Contact: Jin-Shing Chen, MD.,PhD 886-2-23123456 ext 65178 chenjs@ntu.edu.tw

Locations
Taiwan
Far Eastern Memorial Hospital Recruiting
Taipei county, Taiwan
Contact: Kung-Tsao Tsai, MD    886-917925017    hikali888@gmail.com   
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    chenjs@ntu.edu.tw   
Principal Investigator: Jin-Shing Chen, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Investigators
Study Chair: Yung-Chie Lee, MD, PhD National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00713362     History of Changes
Other Study ID Numbers: 200801030R
Study First Received: July 9, 2008
Last Updated: December 13, 2012

Keywords provided by National Taiwan University Hospital:
Aspiration, chest tube, pneumothorax, thoracoscopic surgery

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 17, 2017