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Status unknownNCT01375283Updated Jan 5, 2012

Sensory Mapping Following Video-assisted Thoracic Surgery

An observational study in Paresthesia, Dysesthesia and Pain, sponsored by Rigshospitalet, Denmark. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-05.

Sponsored by Rigshospitalet, Denmark · Observational

The sponsor has not verified this record recently (last verified Jan 2012), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
48
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Paresthesia
  • Dysesthesia
  • Pain

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing video-assisted thoracic surgery

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
48 participants (estimated)

Groups and cohorts

  • lung cancer surgery
05

What researchers measure

Primary outcomes

  1. Area (cm2)

    Size of sensory dysfunction

    Time frame: 3 months

Secondary outcomes

  1. Pain

    pain intensity /numerical rating scale)

    Time frame: 3 months

06

Study locations

1 of 1 sites recruiting
  • Section for Surgical Pathophysiology 4074
    Copenhagen, 2100, Denmark
    • Kim Wildgaard · Contact · 35454236
    • Kim Wildgaard, MD · Principal investigator
    • Thomas Ringsted, Research nurse · Sub investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT01375283
Lead sponsor
Rigshospitalet, Denmark
Responsible party
Kim Wildgaard (MD, Rigshospitalet, Denmark) — Principal investigator
First posted
Jun 17, 2011
Start date
Jun 2011
Primary completion
Aug 2012 (estimated)
Last update
Jan 5, 2012

Study contacts

Kim Wildgaard, MD
Contact
wildgaard@thoracotomy.eu
+45 3545 3246
Mads Werner, MD,
study chair · Multidisciplinary Pain Center
Kim Wildgaard
principal investigator · Section for Surgical Pathophysiology
Henrik Kehlet, MD
study director · Section for Surgical Pathophysiology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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