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Pneumothorax | Improving Primary Spontaneous Pneumothorax (PSP) Treatment Techniques in VATS

Pneumothorax research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pneumothorax

Pleurodesis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:VATS pleurodesisBased 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

wedge resection

Wedge resection and pleurodosis

Study Status

Unknown status

Start Date: July 2011

Completed Date: November 2013

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Recurrence of Primary Spontaneous Pneumothorax (PSP)

Secondary Outcome: Did not recurrence

Study sponsors, principal investigator, and references

Principal Investigator: Jun Liu, associate director

Lead Sponsor: Beijing Haidian Hospital

Collaborator: Peking University People's Hospital

More information:https://clinicaltrials.gov/show/NCT01463553

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