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

Pneumothorax Clinical Trial

Official title:

A Prospective Randomized Study of a Modified Two-port Thoracoscopic Technique Versus Axillary Minithoracotomy for the Treatment of Recurrent Spontaneous Pneumothorax.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192217
• Other study ID #: AHEPACTS-01
• Status: Completed
• Phase: N/A
• First received: August 27, 2010
• Last updated: August 31, 2010
• Start date: January 2006
• Est. completion date: February 2009

Study information

• Verified date: January 2009
• Source: AHEPA University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• ipsilateral recurrent spontaneous pneumothorax

• first episode of contralateral pneumothorax

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumothorax

Intervention

Procedure:
• Modified thoracoscopic technique
Two-port thoracoscopic technique
• Axillary mini-thoracotomy
Axillary mini-thoracotomy

Locations

Country	Name	City	State
Greece	AHEPA University Hospital Department of Cardiothoracic Surgery	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
AHEPA University Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pneumothorax recurrence rate	Recurrence rate		No
Primary	Postoperative complication rate	Postoperative complications		No
Primary	Patient satisfaction with treatment			No
Secondary	Duration of one-lung ventilation			No
Secondary	Total operative time			No
Secondary	Duration of chest tube drainage			No
Secondary	Length of postoperative hospital stay			No
Secondary	Incidence of chronic pain			No