Chronic Pain After Video-assisted Thoracoscopic Surgery (... | NCT00969423

Studies
Chronic Pain After Video-assisted Thoracoscopic Surgery (VATS) Surgery for Pneumothorax

NCT00969423

Sponsor

Rigshospitalet, Denmark

Status

Terminated

Last Update Posted

Aug 18, 2011Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

Pneumothorax

Interventions

5mm videoscope
10mm videoscope

Countries

Denmark

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

unable to recruit

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Dec 2011Estimated

Completion Date

Not provided

First Submitted Date

Aug 31, 2009

First Submission Date that Met QC Criteria

Aug 31, 2009

First Posted Date

Sep 1, 2009Estimated

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 17, 2011

Last Update Posted Date

Aug 18, 2011Estimated

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 study will investigate characteristics of chronic pain after VATS surgery with two different sizes of videoscopic equipment.

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

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
5 mm equipment	Experimental	5 mm videoscopic equipment	Device: 5mm videoscope
10 mm	Experimental	Use of standard 10 mm VATS equipment	Device: 10mm videoscope

Interventions

Name	Type	Description	Arm Group Labels	Other Names
5mm videoscope	Device	use of 5mm videoscope	5 mm equipment
10mm videoscope

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
QST score		2 years
Post surgical pain		2 years

Secondary Outcomes

Measure	Description	Time Frame
Patient related factors, depression, coping etc.		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

PSP
Able to understand and give consent
Can read
Residing in Denmark

Exclusion Criteria:

Unable to understand the written information in Danish
Abuse (Medicine, Drugs, Alcohol)
Severe psychiatric Illness
Conflicting neurological disease
Conversion to open surgery
Use of neuroaxial analgesia
Use of electric cauterizer necessitated
Additional thoracic surgery in the investigation period

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kim Wildgaard, MD	Section for Surgical Pathophysiology 4074 Copenhagen, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet		Copenhagen		dk-2100	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19307137	Background	Wildgaard K, Ravn J, Kehlet H. Chronic post-thoracotomy pain: a critical review of pathogenic mechanisms and strategies for prevention. Eur J Cardiothorac Surg. 2009 Jul;36(1):170-80. doi: 10.1016/j.ejcts.2009.02.005.

ID	Term
D010995	Pleural Diseases
D012140	Respiratory Tract Diseases
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

ID	Term
D011030	Pneumothorax
D009437	Neuralgia
D059350	Chronic Pain