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

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. Identifier: NCT01192217
Recruitment Status : Completed
First Posted : September 1, 2010
Last Update Posted : September 1, 2010
Information provided by:
AHEPA University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Pneumothorax Procedure: Modified thoracoscopic technique Procedure: Axillary mini-thoracotomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
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.
Study Start Date : January 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. pneumothorax recurrence rate
    Recurrence rate

  2. Postoperative complication rate
    Postoperative complications

  3. Patient satisfaction with treatment

Secondary Outcome Measures :
  1. Duration of one-lung ventilation
  2. Total operative time
  3. Duration of chest tube drainage
  4. Length of postoperative hospital stay
  5. Incidence of chronic pain

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

Inclusion Criteria:

  • ipsilateral recurrent spontaneous pneumothorax
  • first episode of contralateral pneumothorax

Exclusion Criteria:

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 identifier (NCT number): NCT01192217

AHEPA University Hospital Department of Cardiothoracic Surgery
Thessaloniki, Greece, 546 36
Sponsors and Collaborators
AHEPA University Hospital
Study Chair: Christos Papakonstantinou, Professor AHEPA University Hospital Identifier: NCT01192217     History of Changes
Other Study ID Numbers: AHEPACTS-01
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: September 1, 2010
Last Verified: January 2009

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

Additional relevant MeSH terms:
Pleural Diseases
Respiratory Tract Diseases