NCT01192217

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2010

Completed
Last Updated

September 1, 2010

Status Verified

January 1, 2009

Enrollment Period

3.1 years

First QC Date

August 27, 2010

Last Update Submit

August 31, 2010

Conditions

Pneumothorax

Keywords

video-assisted thoracic surgeryaxillary mini-thoracotomybullectomy

Outcome Measures

Primary Outcomes (3)

  • pneumothorax recurrence rate

    Recurrence rate

  • Postoperative complication rate

    Postoperative complications

  • Patient satisfaction with treatment

Secondary Outcomes (5)

  • Duration of one-lung ventilation

  • Total operative time

  • Duration of chest tube drainage

  • Length of postoperative hospital stay

  • Incidence of chronic pain

Study Arms (2)

VATS group

ACTIVE COMPARATOR
Procedure: Modified thoracoscopic technique

Mini-thoracotomy group

ACTIVE COMPARATOR
Procedure: Axillary mini-thoracotomy

Interventions

Modified thoracoscopic techniquePROCEDURE

Two-port thoracoscopic technique

Also known as: VATS
VATS group
Axillary mini-thoracotomyPROCEDURE

Axillary mini-thoracotomy

Also known as: Thoracotomy
Mini-thoracotomy group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ipsilateral recurrent spontaneous pneumothorax
  • first episode of contralateral pneumothorax

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AHEPA University Hospital Department of Cardiothoracic Surgery

Thessaloniki, 546 36, Greece

Location

MeSH Terms

Conditions

Pneumothorax

Interventions

Thoracic Surgery, Video-AssistedThoracotomy

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ThoracoscopyEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisVideo-Assisted SurgeryMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Christos Papakonstantinou, Professor

    AHEPA University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 27, 2010

First Posted

September 1, 2010

Study Start

January 1, 2006

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

September 1, 2010

Record last verified: 2009-01

Locations

GR(1)