NCT01375283

Brief Summary

This is a prospective observational cohort study on changes in sensory mapping.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

1.2 years

First QC Date

June 15, 2011

Last Update Submit

January 4, 2012

Conditions

ParesthesiaDysesthesiaPain

Outcome Measures

Primary Outcomes (1)

  • Area (cm2)

    Size of sensory dysfunction

    3 months

Secondary Outcomes (1)

  • Pain

    3 months

Study Arms (1)

lung cancer surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing video-assisted thoracic surgery

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Section for Surgical Pathophysiology 4074

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

ParesthesiaPain

Condition Hierarchy (Ancestors)

Somatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mads Werner, MD,

    Multidisciplinary Pain Center

    STUDY CHAIR

  • Kim Wildgaard

    Section for Surgical Pathophysiology

    PRINCIPAL INVESTIGATOR

  • Henrik Kehlet, MD

    Section for Surgical Pathophysiology

    STUDY DIRECTOR

Central Study Contacts

Kim Wildgaard, MD

CONTACT

+45 3545 3246wildgaard@thoracotomy.eu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 15, 2011

First Posted

June 17, 2011

Study Start

June 1, 2011

Primary Completion

August 1, 2012

Last Updated

January 5, 2012

Record last verified: 2012-01

Locations

DK(1)