Sensory Mapping Following Video-assisted Thoracic Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Rigshospitalet, Denmark.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Kim Wildgaard, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01375283
First received: June 15, 2011
Last updated: January 4, 2012
Last verified: January 2012
  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 Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Area (cm2) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Size of sensory dysfunction


Secondary Outcome Measures:
  • Pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kim Wildgaard, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01375283     History of Changes
Other Study ID Numbers: H4-2010-118#2
Study First Received: June 15, 2011
Last Updated: January 4, 2012
Health Authority: Denmark: Danish Board of Health

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

ClinicalTrials.gov processed this record on July 23, 2014