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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:
Information provided by:
AHEPA University Hospital
ClinicalTrials.gov Identifier:
NCT01192217
First received: August 27, 2010
Last updated: August 31, 2010
Last verified: January 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by AHEPA University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ipsilateral recurrent spontaneous pneumothorax
  • first episode of contralateral pneumothorax

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT01192217     History of Changes
Other Study ID Numbers: AHEPACTS-01
Study First Received: August 27, 2010
Last Updated: August 31, 2010
Health Authority: Greece: Ethics Committee

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

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013