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

August 31, 2010 updated by: AHEPA University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 546 36
        • AHEPA University Hospital Department of Cardiothoracic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ipsilateral recurrent spontaneous pneumothorax
  • first episode of contralateral pneumothorax

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
pneumothorax recurrence rate
Recurrence rate
Postoperative complication rate
Postoperative complications
Patient satisfaction with treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHEPA University Hospital

Investigators

  • Study Chair: Christos Papakonstantinou, Professor, Ahepa University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

August 27, 2010

First Submitted That Met QC Criteria

August 31, 2010

First Posted (Estimate)

September 1, 2010

Study Record Updates

Last Update Posted (Estimate)

September 1, 2010

Last Update Submitted That Met QC Criteria

August 31, 2010

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHEPACTS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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