ParesthesiaNCT01375283
Sensory Mapping Following Video-assisted Thoracic Surgery
An observational study of Paresthesia and Dysesthesia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This is a prospective observational cohort study on changes in sensory mapping. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paresthesia, Dysesthesia, Pain
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2011to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing video-assisted thoracic surgery
Who may be able to join
- Age < 18 years old
- Elective lung cancer surgery (VATS)
Who cannot join
- does not understand Danish
- cognitive reduction
- bilateral procedure planned
- previous thoracic surgery
- pregnant or nursing
- known nerve affection from other cause
Show all 9Show fewer
- alcohol/substance abuse
- inability to cooperate to pain scoring/sensory examination
- > 5 mg methylprednisolone/day
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Section for Surgical Pathophysiology 4074
Copenhagen, 2100
Kim Wildgaard, 35454236
Kim Wildgaard, MD
About this study
This is a prospective observational cohort study on changes in sensory mapping.
- Conditions
- Paresthesia, Dysesthesia, Pain
- Medical subject headings
- Paresthesia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| lung cancer surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area (cm2)
Size of sensory dysfunction
Measured: 3 months
Secondary outcomes (1)
Pain
pain intensity /numerical rating scale)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParesthesiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Wildgaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Mads Werner, MD,, Study chair, Multidisciplinary Pain CenterKim Wildgaard, Principal investigator, Section for Surgical PathophysiologyHenrik Kehlet, MD, Study director, Section for Surgical Pathophysiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375283
- Sponsor's protocol ID
- H4-2010-118#2
- Status last verified
- Jan 2012
- First submitted
- 15 Jun 2011
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Mapping Following Video-assisted Thoracic Surgery
- ClinicalTrials.gov ID
- NCT01375283
- Acronym / sponsor ID
- H4-2010-118#2
- Conditions
- Paresthesia, Dysesthesia, Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Aug 2012 (estimated)
- First posted
- 17 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective observational cohort study on changes in sensory mapping.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung cancer surgery | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing video-assisted thoracic surgery
Key inclusion criteria (2 listed)
- Age < 18 years old
- Elective lung cancer surgery (VATS)
Key exclusion criteria (9 listed)
- does not understand Danish
- cognitive reduction
- bilateral procedure planned
- previous thoracic surgery
- pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Area (cm2)
Time frame: 3 months
Size of sensory dysfunction
1 secondary outcome
Pain
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paresthesia and Dysesthesia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kim Wildgaard, MD (+45 3545 3246, wildgaard@thoracotomy.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area (cm2) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2012; AzTrials last refreshed its copy on 30 Oct 2026.