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Effect of Dissecting of The Inferior Pulmonary Ligament on Postoperative Pulmonary Reexpansion and Recurrence

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ClinicalTrials.gov Identifier: NCT02558608
Recruitment Status : Unknown
Verified October 2015 by Jian Cui, Beijing Haidian Hospital.
Recruitment status was:  Recruiting
First Posted : September 24, 2015
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
Jian Cui, Beijing Haidian Hospital

Brief Summary:
This subject analysis of the influence of the dissociating inferior pulmonary ligament on pulmonary reexpansion and recurrence in the treatment of primary spontaneous pneumothorax by video assisted thoracic surgery. All patients are randomly divided into two groups: group A and group B. Wedge resection(WR) will be performed for all patients. Investigators dissect the inferior pulmonary ligament(DIPL) for group A. Investigators do not dissect the inferior pulmonary ligament for group B. The pulmonary reexpansion and recurrence rate are observed between the two groups.

Condition or disease Intervention/treatment Phase
Pneumothorax Procedure: DIPL Procedure: WR Procedure: thoracoscopic surgery Phase 3

Detailed Description:
Wedge resection of the lung is usually used in the treatment of primary spontaneous pneumothorax. And the pleural treatment also might be used. But part of secondary pneumothorax patients who had undergone surgical, the bullae can be found especially in the apical of lung, even if the pleural have been treated in some way.This subject provides a new way of thinking and method to solve the problem of recurrent spontaneous pneumothorax.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Dissecting of The Inferior Pulmonary Ligament on Postoperative Pulmonary Reexpansion and Recurrence After Operation by Video-assisted Thoracic Surgery in the Treatment of Primary Spontaneous Pneumothorax(PSP)
Study Start Date : June 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : April 2020


Arm Intervention/treatment
Experimental: WR AND DIPL
patients undergo wedge resection and dissection the inferior pulmonary ligament by thoracoscopic surgery or video assisted thoracoscopic surgery
Procedure: DIPL
dissection of the inferior pulmonary ligament

Procedure: WR
wedge resection of the lung bleb

Procedure: thoracoscopic surgery
surgery performed by video assisted thoracoscopy

Active Comparator: WR
patients undergo wedge resection by thoracoscopic surgery or video assisted thoracoscopic surgery without dissection the inferior pulmonary ligament
Procedure: WR
wedge resection of the lung bleb

Procedure: thoracoscopic surgery
surgery performed by video assisted thoracoscopy




Primary Outcome Measures :
  1. recurrence rate [ Time Frame: 3 years ]
    the 3- year recurrence rate of pneumothorax after surgery.


Secondary Outcome Measures :
  1. pulmonary reexpansion rate [ Time Frame: 1 day and 4 days ]
    the proportion of pulmonary reexpansion on the first and fourth day after operation.



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Ages Eligible for Study:   10 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patients diagnosis pneumothorax with chest radiograph or computed tomography (CT)
  2. The clinical and final pathological diagnosis for patient is PSP.
  3. The patients with stable vital signs, no contraindication for operation and no communication barriers.
  4. The patients,after informed of test content, significance and risk, who voluntarily enroll and sign informed consent.

Exclusion Criteria:

  1. The patients who refuse to do a video assisted thoracic surgery.
  2. The patients with pneumothorax with specific causes such as pulmonary hamartoangiomyomatosis, catamenial pneumothorax, and pneumothorax secondary to chronic obstructive pulmonary disease.
  3. The patients who were older than 50 years
  4. The patients with familial history of pneumothorax.
  5. The patients with mental disorders, low Intelligence Quotient, can not objectively reflect the indicators of observation.
  6. The patients who refuse to follow-up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558608


Contacts
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Contact: Jian Cui, director +861082693152 cuijiandoctor@sina.com

Locations
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China, Beijing
Beijing Haidian Hospital Recruiting
Beijing, Beijing, China, 100086
Contact: Jian Cui, Director    +861082693152    cuijiandoctor@sina.com   
Sponsors and Collaborators
Chinese Medical Association
Investigators
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Study Director: Jian Cui, director Beijing Haidian Hospital
Publications:
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Responsible Party: Jian Cui, Principal Investigator, Beijing Haidian Hospital
ClinicalTrials.gov Identifier: NCT02558608    
Other Study ID Numbers: FPL001
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015
Keywords provided by Jian Cui, Beijing Haidian Hospital:
Prime Spontaneous Pneumothorax
recurrence
Additional relevant MeSH terms:
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Pneumothorax
Recurrence
Disease Attributes
Pathologic Processes
Pleural Diseases
Respiratory Tract Diseases