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Video-assisted Thoracic Surgery (VATS) Versus Axillary Mini-thoracotomy for the Treatment of Recurrent Spontaneous Pneumothorax

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01192217
First Posted: September 1, 2010
Last Update Posted: September 1, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AHEPA University Hospital
  Purpose

The investigators conducted a prospective randomized study to compare axillary minithoracotomy versus a modified two-port thoracoscopic technique for surgical pleurodesis in patients with recurrent spontaneous pneumothorax operated in a single institution.

The main objective of the study was to investigate possible differences regarding short- and long-term clinical outcome between the two different techniques.


Condition Intervention
Pneumothorax Procedure: Modified thoracoscopic technique Procedure: Axillary mini-thoracotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study of a Modified Two-port Thoracoscopic Technique Versus Axillary Minithoracotomy for the Treatment of Recurrent Spontaneous Pneumothorax.

Resource links provided by NLM:


Further study details as provided by AHEPA University Hospital:

Primary Outcome Measures:
  • pneumothorax recurrence rate
    Recurrence rate

  • Postoperative complication rate
    Postoperative complications

  • Patient satisfaction with treatment

Secondary Outcome Measures:
  • Duration of one-lung ventilation
  • Total operative time
  • Duration of chest tube drainage
  • Length of postoperative hospital stay
  • Incidence of chronic pain

Enrollment: 66
Study Start Date: January 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: VATS group Procedure: Modified thoracoscopic technique
Two-port thoracoscopic technique
Other Name: VATS
Active Comparator: Mini-thoracotomy group Procedure: Axillary mini-thoracotomy
Axillary mini-thoracotomy
Other Name: Thoracotomy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ipsilateral recurrent spontaneous pneumothorax
  • first episode of contralateral pneumothorax

Exclusion Criteria:

  Contacts and Locations
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): NCT01192217


Locations
Greece
AHEPA University Hospital Department of Cardiothoracic Surgery
Thessaloniki, Greece, 546 36
Sponsors and Collaborators
AHEPA University Hospital
Investigators
Study Chair: Christos Papakonstantinou, Professor AHEPA University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT01192217     History of Changes
Other Study ID Numbers: AHEPACTS-01
First Submitted: August 27, 2010
First Posted: September 1, 2010
Last Update Posted: September 1, 2010
Last Verified: January 2009

Keywords provided by AHEPA University Hospital:
video-assisted thoracic surgery
axillary mini-thoracotomy
bullectomy

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases