Efficacy of the Additional Mechanical Pleurodesis for Surgical Management of Primary Spontaneous Pneumothorax
Phase III Study of Evaluation of the Efficacy of Additional Mechanical Pleurodesis After Thoracoscopic Wedge Resection for the Management of Primary Spontaneous Pneumothorax
1 other identifier
interventional
1,440
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2006
Longer than P75 for phase_3
1 active site
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
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedSeptember 30, 2011
September 1, 2011
3.7 years
February 1, 2008
September 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
recurrence
follow up more than 1 year
Secondary Outcomes (1)
complications
follow up more than 1 year
Interventions
stapled wedge resection of the lung mechanical pleural abrasion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- patient refusal and reoperation case
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seungnam, Gyeonggi-do, 463-707, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sanghoon Jheon, M.D., Ph.D.
Seoul National University College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Department of Thoracic and Cardiovascular Surgery
Study Record Dates
First Submitted
February 1, 2008
First Posted
February 14, 2008
Study Start
November 1, 2006
Primary Completion
July 1, 2010
Study Completion
July 1, 2011
Last Updated
September 30, 2011
Record last verified: 2011-09