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

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Seoul National University

Status and phase

Completed
Phase 3

Conditions

Primary Spontaneous Pneumothorax

Treatments

Procedure: thoracoscopic surgery

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

1,440 patients

Sex

All

Ages

16 to 35 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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