Efficacy of the Additional Mechanical Pleurodesis for Surgical Management of Primary Spontaneous Pneumothorax
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ClinicalTrials.gov Identifier: NCT00615849 |
Recruitment Status :
Completed
First Posted : February 14, 2008
Last Update Posted : September 30, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Spontaneous Pneumothorax | Procedure: thoracoscopic surgery | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1440 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase III Study of Evaluation of the Efficacy of Additional Mechanical Pleurodesis After Thoracoscopic Wedge Resection for the Management of Primary Spontaneous Pneumothorax |
Study Start Date : | November 2006 |
Actual Primary Completion Date : | July 2010 |
Actual Study Completion Date : | July 2011 |

- Procedure: thoracoscopic surgery
stapled wedge resection of the lung mechanical pleural abrasion
- recurrence [ Time Frame: follow up more than 1 year ]
- complications [ Time Frame: follow up more than 1 year ]

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Ages Eligible for Study: | 16 Years to 35 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- recurrent pneumothorax
- bilateral pneumothorax
- total collapse/tension pneumothorax
- previous history of contralateral pneumothorax
- visible bulla on simple X-ray
- special occupation/situation
- air leakage more than 2 days with drainage catheter for 1st attack patients
Exclusion Criteria:
- patient refusal and reoperation case

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 ClinicalTrials.gov identifier (NCT number): NCT00615849
Korea, Republic of | |
Seoul National University Bundang Hospital | |
Seungnam, Gyeonggi, Korea, Republic of, 463-707 |
Principal Investigator: | Sanghoon Jheon, M.D., Ph.D. | Seoul National University College of Medicine |
Responsible Party: | Sanghoon Jheon, Chief, Department of Thoracic and Cardiovascular Surgery, Seoul National University Bundang Hospital |
ClinicalTrials.gov Identifier: | NCT00615849 |
Other Study ID Numbers: |
KPT |
First Posted: | February 14, 2008 Key Record Dates |
Last Update Posted: | September 30, 2011 |
Last Verified: | September 2011 |
pneumothorax, thoracoscopy, pleurodesis |
Pneumothorax Pleural Diseases Respiratory Tract Diseases |