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Sensory Mapping Following Video-assisted Thoracic Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Kim Wildgaard, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01375283
First Posted: June 17, 2011
Last Update Posted: January 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kim Wildgaard, Rigshospitalet, Denmark
  Purpose
This is a prospective observational cohort study on changes in sensory mapping.

Condition
Paresthesia Dysesthesia Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sensory Mapping Following Video-assisted Thoracic Surgery

Further study details as provided by Kim Wildgaard, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Area (cm2) [ Time Frame: 3 months ]
    Size of sensory dysfunction


Secondary Outcome Measures:
  • Pain [ Time Frame: 3 months ]
    pain intensity /numerical rating scale)


Estimated Enrollment: 48
Study Start Date: June 2011
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
lung cancer surgery

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing video-assisted thoracic surgery
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375283


Contacts
Contact: Kim Wildgaard, MD +45 3545 3246 wildgaard@thoracotomy.eu

Locations
Denmark
Section for Surgical Pathophysiology 4074 Recruiting
Copenhagen, Denmark, 2100
Contact: Kim Wildgaard    35454236      
Principal Investigator: Kim Wildgaard, MD         
Sub-Investigator: Thomas Ringsted, Research nurse         
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Chair: Mads Werner, MD, Multidisciplinary Pain Center
Principal Investigator: Kim Wildgaard Section for Surgical Pathophysiology
Study Director: Henrik Kehlet, MD Section for Surgical Pathophysiology
  More Information

Responsible Party: Kim Wildgaard, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01375283     History of Changes
Other Study ID Numbers: H4-2010-118#2
First Submitted: June 15, 2011
First Posted: June 17, 2011
Last Update Posted: January 5, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Paresthesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms