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

Primary Spontaneous Pneumothorax Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00615849
• Other study ID #: KPT
• Status: Completed
• Phase: Phase 3
• First received: February 1, 2008
• Last updated: September 28, 2011
• Start date: November 2006
• Est. completion date: July 2011

Study information

• Verified date: September 2011
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1440
• Est. completion date: July 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumothorax
• Primary Spontaneous Pneumothorax

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seungnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence		follow up more than 1 year	No
Secondary	complications		follow up more than 1 year	No