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

Sponsor
AHEPA University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01192217
Collaborator
(none)
66
Enrollment
1
Location
2
Arms
37
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Modified thoracoscopic technique
  • Procedure: Axillary mini-thoracotomy
 N/A

Study Design

Study Type:
Interventional
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 :
Jan 1, 2006
Actual Primary Completion Date :
Feb 1, 2009
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: VATS group

Procedure: Modified thoracoscopic technique
Two-port thoracoscopic technique
Other Names:
  • VATS

    		•
    Active Comparator: Mini-thoracotomy group

    Procedure: Axillary mini-thoracotomy
    Axillary mini-thoracotomy
    Other Names:
  • Thoracotomy

    		•

    Outcome Measures

    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 []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ipsilateral recurrent spontaneous pneumothorax

    • first episode of contralateral pneumothorax

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01192217
    Other Study ID Numbers:
    • AHEPACTS-01
    First Posted:
    Sep 1, 2010
    Last Update Posted:
    Sep 1, 2010
    Last Verified:
    Jan 1, 2009
    Keywords provided by , ,
    video-assisted thoracic surgery
    axillary mini-thoracotomy
    bullectomy
    Additional relevant MeSH terms:
    Pneumothorax

    Study Results

    No Results Posted as of Sep 1, 2010