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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sanghoon Jheon, Seoul National University Bundang Hospital

ClinicalTrials.gov Identifier:

NCT00615849

First received: February 1, 2008

Last updated: September 28, 2011

Last verified: September 2011

History of Changes

Purpose

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.

Condition	Intervention	Phase
Primary Spontaneous Pneumothorax	Procedure: thoracoscopic surgery	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: primary spontaneous pneumothorax

MedlinePlus related topics: Collapsed Lung

Genetic and Rare Diseases Information Center resources: Primary Spontaneous Pneumothorax

U.S. FDA Resources

Further study details as provided by Sanghoon Jheon, Seoul National University Bundang Hospital:

Primary Outcome Measures:

recurrence [ Time Frame: follow up more than 1 year ]

Secondary Outcome Measures:

complications [ Time Frame: follow up more than 1 year ]


Enrollment:	1440
Study Start Date:	November 2006
Study Completion Date:	July 2011
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Intervention Details:

stapled wedge resection of the lung mechanical pleural abrasion

Eligibility


Ages Eligible for Study:	16 Years to 35 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615849

Locations


Korea, Republic of
Seoul National University Bundang Hospital
Seungnam, Gyeonggi, Korea, Republic of, 463-707

Sponsors and Collaborators

Seoul National University Bundang Hospital

Investigators


Principal Investigator:	Sanghoon Jheon, M.D., Ph.D.	Seoul National University College of Medicine

More Information


Responsible Party:	Sanghoon Jheon, Chief, Department of Thoracic and Cardiovascular Surgery, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:	NCT00615849 History of Changes
Other Study ID Numbers:	KPT
Study First Received:	February 1, 2008
Last Updated:	September 28, 2011

Keywords provided by Sanghoon Jheon, Seoul National University Bundang Hospital:


pneumothorax, thoracoscopy, pleurodesis

Additional relevant MeSH terms:


Pneumothorax Pleural Diseases Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2017

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