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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00615849
Enrollment
1440
Registered
2008-02-14
Start date
2006-11-30
Completion date
2011-07-31
Last updated
2011-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Spontaneous Pneumothorax

Keywords

pneumothorax, thoracoscopy, pleurodesis

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.

Interventions

PROCEDUREthoracoscopic surgery

stapled wedge resection of the lung mechanical pleural abrasion

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
recurrencefollow up more than 1 year

Secondary

MeasureTime frame
complicationsfollow up more than 1 year

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026