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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
Sponsor:
Information provided by (Responsible Party):
Sanghoon Jheon, Seoul National University Bundang Hospital

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.

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



Intervention Details:
    Procedure: thoracoscopic surgery
    stapled wedge resection of the lung mechanical pleural abrasion


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

Secondary Outcome Measures :
  1. 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
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

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

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 Posted: February 14, 2008    Key Record Dates
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