Improving Primary Spontaneous Pneumothorax (PSP) Treatment Techniques in VATS

Phase 4

• Conditions: Pneumothorax; Pleurodesis
• Interventions: Procedure: VATS pleurodesis

• Registration Number: NCT01463553
• Lead Sponsor: Beijing Haidian Hospital

Brief Summary

The purpose of this study is to:

1. Evaluate the validity of using abnormal characteristics of the pneumothorax line, as evaluated from chest X-ray film, as the operative indications for video-assisted thoracic surgery (VATS) on primary spontaneous pneumothorax (PSP).

2. Through a randomized double blind controlled trial on patients whose PSP was caused by lung bullae, evaluate the effectiveness of pleurodesis in terms of the rate of recurrence of PSP and the trauma of the operation on patients.

3. Based on the findings, establish selection standards for the timing of surgery to treat PSP by VATS and establish technical specifications for performing operations on different types of lung bullae. The goal is to improve the diagnosis and treatment of PSP so as to reduce the recurrence rate of pneumothorax, reduce the trauma of operation, shorten hospital stays and postoperative recovery time, and provide better services for returning to everyday life and improving the quality of life for patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-10-30
• Study First Submitted QC: 2011-11-01
• Study First Posted: 2011-11-02
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-10
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

1. patients in whom obvious bullous forms are seen in PSP pneumothorax lines, or whose pneumothorax lines are rough and interrupted with or without thoracentesis, thoracic close drainage
2. patients whose lung compression exceeded 30% for the first incidence of pneumothorax
3. patients between the ages of 14 and 40, with normal vital signs (body temperature, breathing, blood pressure, pulse) and normal results on routine examination (routine blood test, liver and kidney functions)
4. no language barrier, such as surdimutism, aphasia
5. patients who voluntarily joined the group and signed the informed consent after reviewing the substance, significance and risks of this experiment

Exclusion Criteria

1. patients who refuse VATS operation
2. patients who refuse the follow-up
3. patients with secondary spontaneous pneumothorax including that caused by emphysema, COPD, asthma, pulmonary lymphangiomyomatosis, thoracic injury and other diseases
4. patients with mental illness, low IQ, or inability to understand the informed consent
5. substance abusers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wedge resection and pleurodosis	VATS pleurodesis	-

Primary Outcome Measures

Name	Time	Method
Recurrence of Primary Spontaneous Pneumothorax (PSP)	24 months	Monitor patients for 24 months to measure recurrence rate of primary spontaneous pneumothorax

Secondary Outcome Measures

Name	Time	Method
Did not recurrence	24months

Trial Locations

Locations (1)

Beijing Haidian Hospital; 🇨🇳 Beijing, Beijing, China