Trial record 14 of 56 for:    "primary spontaneous pneumothorax" OR "pneumothorax" OR "spontaneous pneumothorax"

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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014