Back to results

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

Primary Purpose

Primary Spontaneous Pneumothorax

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

thoracoscopic surgery

About this trial

This is an interventional treatment trial for Primary Spontaneous Pneumothorax focused on measuring pneumothorax, thoracoscopy, pleurodesis

Eligibility Criteria

16 Years - 35 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Seoul National University Bundang Hospital

Outcomes

Primary Outcome Measures

recurrence

Secondary Outcome Measures

complications

Full Information

NCT ID

NCT00615849

First Posted

February 1, 2008

Last Updated

September 28, 2011

Sponsor

Seoul National University Bundang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00615849

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Spontaneous Pneumothorax

Keywords

pneumothorax, thoracoscopy, pleurodesis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1440 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

thoracoscopic surgery

Intervention Description

stapled wedge resection of the lung mechanical pleural abrasion

Primary Outcome Measure Information:

Title

recurrence

Time Frame

follow up more than 1 year

Secondary Outcome Measure Information:

Title

complications

Time Frame

follow up more than 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Seoul National University College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Bundang Hospital

City

Seungnam

State/Province

Gyeonggi

ZIP/Postal Code

463-707

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs