Video-assisted Thoracic Surgery (VATS) Versus Axillary Mi... | NCT01192217

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

NCT01192217

Sponsor

AHEPA University Hospital

Status

Completed

Last Update Posted

Sep 1, 2010Estimated

Enrollment

66Actual

Phase

Not Applicable

Conditions

Pneumothorax

Interventions

Modified thoracoscopic technique
Axillary mini-thoracotomy

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Aug 27, 2010

First Submission Date that Met QC Criteria

Aug 31, 2010

First Posted Date

Sep 1, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2010

Last Update Posted Date

Sep 1, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VATS group	Active Comparator		Procedure: Modified thoracoscopic technique
Mini-thoracotomy group	Active Comparator		Procedure: Axillary mini-thoracotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Modified thoracoscopic technique	Procedure	Two-port thoracoscopic technique	VATS group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Duration of one-lung ventilation
Total operative time
Duration of chest tube drainage

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ipsilateral recurrent spontaneous pneumothorax
first episode of contralateral pneumothorax

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christos Papakonstantinou, Professor	AHEPA University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AHEPA University Hospital Department of Cardiothoracic Surgery		Thessaloniki		546 36	Greece

Type	Date	Date Unknown
Release	Jul 12, 2020
Reset	Jul 29, 2020

Submission Tracking

Estimated Results First Submitted Date

Jul 12, 2020

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 12, 2020			Jul 29, 2020

Condition Browse Module

MeSH Terms

ID	Term
D011030	Pneumothorax

Ancestor Terms

ID	Term
D010995	Pleural Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020775	Thoracic Surgery, Video-Assisted
D013908	Thoracotomy

Ancestor Terms

ID	Term
D013906	Thoracoscopy
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided