- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00615849
Efficacy of the Additional Mechanical Pleurodesis for Surgical Management of Primary Spontaneous Pneumothorax
September 28, 2011 updated by: Sanghoon Jheon, Seoul National University Bundang Hospital
Phase III Study of Evaluation of the Efficacy of Additional Mechanical Pleurodesis After Thoracoscopic Wedge Resection for the Management of Primary Spontaneous Pneumothorax
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1440
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi
-
Seungnam, Gyeonggi, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 35 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
recurrence
Time Frame: follow up more than 1 year
|
follow up more than 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
complications
Time Frame: follow up more than 1 year
|
follow up more than 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sanghoon Jheon, M.D., Ph.D., Seoul National University College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
February 1, 2008
First Submitted That Met QC Criteria
February 1, 2008
First Posted (Estimate)
February 14, 2008
Study Record Updates
Last Update Posted (Estimate)
September 30, 2011
Last Update Submitted That Met QC Criteria
September 28, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KPT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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