Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
AHEPA University Hospital
ClinicalTrials.gov Identifier:
NCT01192217
First received: August 27, 2010
Last updated: August 31, 2010
Last verified: January 2009

August 27, 2010
August 31, 2010
January 2006
February 2009   (final data collection date for primary outcome measure)
  • pneumothorax recurrence rate [ Designated as safety issue: No ]
    Recurrence rate
  • Postoperative complication rate [ Designated as safety issue: No ]
    Postoperative complications
  • Patient satisfaction with treatment [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01192217 on ClinicalTrials.gov Archive Site
  • Duration of one-lung ventilation [ Designated as safety issue: No ]
  • Total operative time [ Designated as safety issue: No ]
  • Duration of chest tube drainage [ Designated as safety issue: No ]
  • Length of postoperative hospital stay [ Designated as safety issue: No ]
  • Incidence of chronic pain [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Video-assisted Thoracic Surgery (VATS) Versus Axillary Mini-thoracotomy for the Treatment of Recurrent Spontaneous Pneumothorax
A Prospective Randomized Study of a Modified Two-port Thoracoscopic Technique Versus Axillary Minithoracotomy for the Treatment of Recurrent Spontaneous Pneumothorax.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pneumothorax
  • Procedure: Modified thoracoscopic technique
    Two-port thoracoscopic technique
    Other Name: VATS
  • Procedure: Axillary mini-thoracotomy
    Axillary mini-thoracotomy
    Other Name: Thoracotomy
  • Active Comparator: VATS group
    Intervention: Procedure: Modified thoracoscopic technique
  • Active Comparator: Mini-thoracotomy group
    Intervention: Procedure: Axillary mini-thoracotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ipsilateral recurrent spontaneous pneumothorax
  • first episode of contralateral pneumothorax

Exclusion Criteria:

  • None
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01192217
AHEPACTS-01
No
Not Provided
AHEPA University Hospital
Not Provided
Study Chair: Christos Papakonstantinou, Professor AHEPA University Hospital
AHEPA University Hospital
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP