Sensory Mapping Following Video-assisted Thoracic Surgery | NCT01375283

Studies
Sensory Mapping Following Video-assisted Thoracic Surgery

NCT01375283

Sponsor

Rigshospitalet, Denmark

Status

Unknown status

Last Update Posted

Jan 5, 2012Estimated

Enrollment

48Estimated

Phase

Not provided

Conditions

Paresthesia
Dysesthesia
Pain

Interventions

Not provided

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

Jan 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Aug 2012Estimated

Completion Date

Not provided

First Submitted Date

Jun 15, 2011

First Submission Date that Met QC Criteria

Jun 16, 2011

First Posted Date

Jun 17, 2011Estimated

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

Jan 4, 2012

Last Update Posted Date

Jan 5, 2012Estimated

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

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Label	Type	Description	Intervention Names
lung cancer surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area (cm2)	Size of sensory dysfunction	3 months

Secondary Outcomes

Measure	Description	Time Frame
Pain	pain intensity /numerical rating scale)	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age < 18 years old
Elective lung cancer surgery (VATS)

Exclusion Criteria:

does not understand Danish
cognitive reduction
bilateral procedure planned
previous thoracic surgery
pregnant or nursing
known nerve affection from other cause
alcohol/substance abuse
inability to cooperate to pain scoring/sensory examination
> 5 mg methylprednisolone/day

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing video-assisted thoracic surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kim Wildgaard, MD	Contact	+45 3545 3246		wildgaard@thoracotomy.eu

Overall Officials

Name	Affiliation	Role
Mads Werner, MD,	Multidisciplinary Pain Center	Study Chair
Kim Wildgaard	Section for Surgical Pathophysiology	Principal Investigator
Henrik Kehlet, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Section for Surgical Pathophysiology 4074	Recruiting	Copenhagen		2100	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D010292	Paresthesia
D010146	Pain

Ancestor Terms

ID	Term
D020886	Somatosensory Disorders
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided