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

NCT ID: NCT00615849

Last Updated: 2011-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Spontaneous Pneumothorax

Keywords

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pneumothorax, thoracoscopy, pleurodesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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thoracoscopic surgery

stapled wedge resection of the lung mechanical pleural abrasion

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sanghoon Jheon

Chief, Department of Thoracic and Cardiovascular Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sanghoon Jheon, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University College of Medicine

Locations

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Seoul National University Bundang Hospital

Seungnam, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KPT

Identifier Type: -

Identifier Source: org_study_id