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Efficacy of the Additional Mechanical Pleurodesis for Surgical Management of Primary Spontaneous Pneumothorax

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00615849
First Posted: February 14, 2008
Last Update Posted: September 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanghoon Jheon, Seoul National University Bundang Hospital
  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: 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

Resource links provided by NLM:


Further study details as provided by Sanghoon Jheon, Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • recurrence [ Time Frame: follow up more than 1 year ]

Secondary Outcome Measures:
  • complications [ Time Frame: follow up more than 1 year ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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
First Submitted: February 1, 2008
First Posted: February 14, 2008
Last Update Posted: September 30, 2011
Last Verified: September 2011

Keywords provided by Sanghoon Jheon, Seoul National University Bundang Hospital:
pneumothorax, thoracoscopy, pleurodesis

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases