Efficacy of the Additional Mechanical Pleurodesis for Surgical Management of Primary Spontaneous Pneumothorax
This study has been completed.
Sponsor:
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Sanghoon Jheon, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT00615849
First received: February 1, 2008
Last updated: September 28, 2011
Last verified: September 2011
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Purpose
For the definite treatment of primary spontaneous pneumothorax(PSP), thoracoscopic bleb obliteration with pleural adhesive procedure is generally accepted as a standard. But additional pleurodesis is potentially useless procedure on the parietal pleura for treating visceral pleural disese. Furthermore, pleural symphysis could deteriorates normal pleural physiology and cause chronic pain. According to our previous study, stapling resection of the bulla without pleurodesis gave comparable result in recurrence comparing with articles with additional pleurodesis. The purpose of this study is to evaluate surgical outcome of thoracoscopic surgery with or without pleural abrasion and to know whether adhesive procedure is essential in the management of PSP.
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Spontaneous Pneumothorax |
Procedure: thoracoscopic surgery |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
primary spontaneous pneumothorax
MedlinePlus related topics:
Collapsed Lung
U.S. FDA Resources
Further study details as provided by Seoul National University Bundang Hospital:
Primary Outcome Measures:
- recurrence [ Time Frame: follow up more than 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- complications [ Time Frame: follow up more than 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 1440 |
| Study Start Date: | November 2006 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Procedure: thoracoscopic surgery
stapled wedge resection of the lung mechanical pleural abrasion
Eligibility| Ages Eligible for Study: | 16 Years to 35 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00615849
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615849
Locations
| Korea, Republic of | |
| Seoul National University Bundang Hospital | |
| Seungnam, Gyeonggi, Korea, Republic of, 463-707 | |
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
| Principal Investigator: | Sanghoon Jheon, M.D., Ph.D. | Seoul National University College of Medicine |
More Information
| Responsible Party: | Sanghoon Jheon, Chief, Department of Thoracic and Cardiovascular Surgery, Seoul National University Bundang Hospital |
| ClinicalTrials.gov Identifier: | NCT00615849 History of Changes |
| Other Study ID Numbers: | KPT |
| Study First Received: | February 1, 2008 |
| Last Updated: | September 28, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Seoul National University Bundang Hospital:
|
pneumothorax, thoracoscopy, pleurodesis |
Additional relevant MeSH terms:
|
Pneumothorax Pleural Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on September 27, 2016