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

Primary Purpose

Pneumothorax

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Modified thoracoscopic technique
Axillary mini-thoracotomy
Sponsored by
AHEPA University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumothorax focused on measuring video-assisted thoracic surgery, axillary mini-thoracotomy, bullectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ipsilateral recurrent spontaneous pneumothorax
  • first episode of contralateral pneumothorax

Exclusion Criteria:

  • None

Sites / Locations

  • AHEPA University Hospital Department of Cardiothoracic Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

VATS group

Mini-thoracotomy group

Arm Description

Outcomes

Primary Outcome Measures

pneumothorax recurrence rate
Recurrence rate
Postoperative complication rate
Postoperative complications
Patient satisfaction with treatment

Secondary Outcome Measures

Duration of one-lung ventilation
Total operative time
Duration of chest tube drainage
Length of postoperative hospital stay
Incidence of chronic pain

Full Information

First Posted
August 27, 2010
Last Updated
August 31, 2010
Sponsor
AHEPA University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01192217
Brief Title
Video-assisted Thoracic Surgery (VATS) Versus Axillary Mini-thoracotomy for the Treatment of Recurrent Spontaneous Pneumothorax
Official Title
A Prospective Randomized Study of a Modified Two-port Thoracoscopic Technique Versus Axillary Minithoracotomy for the Treatment of Recurrent Spontaneous Pneumothorax.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AHEPA University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax
Keywords
video-assisted thoracic surgery, axillary mini-thoracotomy, bullectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VATS group
Arm Type
Active Comparator
Arm Title
Mini-thoracotomy group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Modified thoracoscopic technique
Other Intervention Name(s)
VATS
Intervention Description
Two-port thoracoscopic technique
Intervention Type
Procedure
Intervention Name(s)
Axillary mini-thoracotomy
Other Intervention Name(s)
Thoracotomy
Intervention Description
Axillary mini-thoracotomy
Primary Outcome Measure Information:
Title
pneumothorax recurrence rate
Description
Recurrence rate
Title
Postoperative complication rate
Description
Postoperative complications
Title
Patient satisfaction with treatment
Secondary Outcome Measure Information:
Title
Duration of one-lung ventilation
Title
Total operative time
Title
Duration of chest tube drainage
Title
Length of postoperative hospital stay
Title
Incidence of chronic pain

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ipsilateral recurrent spontaneous pneumothorax first episode of contralateral pneumothorax Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christos Papakonstantinou, Professor
Organizational Affiliation
AHEPA University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
AHEPA University Hospital Department of Cardiothoracic Surgery
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece

12. IPD Sharing Statement

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

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