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

This study has been completed.
Sponsor:
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
History of Changes
  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:

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
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
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

No publications provided

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 June 17, 2013