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Completed

NCT Number: NCT00615849

Efficacy of the Additional Mechanical Pleurodesis for Surgical 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.

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Key information

Conditions

Primary Spontaneous Pneumothorax Pleural Diseases Pneumothorax Respiratory Tract Diseases

Age range

16 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital

Seungnam, Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thoracoscopic Surgery

Procedure

stapled wedge resection of the lung mechanical pleural abrasion

Primary outcomes

  1. recurrence

    Time frame: follow up more than 1 year

Secondary outcomes

  1. complications

    Time frame: follow up more than 1 year

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Phase III Study of Evaluation of the Efficacy of Additional Mechanical Pleurodesis After Thoracoscopic Wedge Resection for the Management of Primary Spontaneous Pneumothorax

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Feb 14, 2008
Registry last updated
Sep 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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