PneumothoraxNCT00969423
Chronic Pain After Video-assisted Thoracoscopic Surgery (VATS) Surgery for Pneumothorax
A study testing 5mm videoscope and 10mm videoscope in people with Pneumothorax, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The study will investigate characteristics of chronic pain after VATS surgery with two different sizes of videoscopic equipment. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Pneumothorax
- What is being tested?
- 5mm videoscope and 10mm videoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2009to Dec 2011
- Phase
- Interventional
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- PSP
- Able to understand and give consent
- Can read
- Residing in Denmark
Who cannot join
- Unable to understand the written information in Danish
- Abuse (Medicine, Drugs, Alcohol)
- Severe psychiatric Illness
- Conflicting neurological disease
- Conversion to open surgery
- Use of neuroaxial analgesia
- Use of electric cauterizer necessitated
- Additional thoracic surgery in the investigation period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Pain After VATS Surgery for Pneumothorax
The study will investigate characteristics of chronic pain after VATS surgery with two different sizes of videoscopic equipment.
- Conditions
- Pneumothorax
- Being tested
- 5mm videoscope, 10mm videoscope
- Keywords
- persistent pain, neuropathic pain, Chronic Pain, VATS, Primary spontaneous pneumothorax patients
- Medical subject headings
- Pneumothorax, Neuralgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5mm videoscopeDevice
use of 5mm videoscope
10mm videoscopeDevice
use of 10mm videoscope
| Study group | Role | What they receive |
|---|---|---|
| 5 mm equipment | Experimental | 5 mm videoscopic equipment Receives: Device: 5mm videoscope |
| 10 mm | Experimental | Use of standard 10 mm VATS equipment Receives: Device: 10mm videoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
QST score
Measured: 2 years
Post surgical pain
Measured: 2 years
Secondary outcomes (1)
Patient related factors, depression, coping etc.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2011 (estimated)
Why it stopped: unable to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumothoraxStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Kim Wildgaard, MD, Principal investigator, Section for Surgical Pathophysiology 4074 Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969423
- Sponsor's protocol ID
- H-A-2009-054
- Status last verified
- Aug 2011
- First submitted
- 31 Aug 2009
- Last updated
- 18 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Wildgaard K, Ravn J, Kehlet H. Chronic post-thoracotomy pain: a critical review of pathogenic mechanisms and strategies for prevention. Eur J Cardiothorac Surg. 2009 Jul;36(1):170-80. doi: 10.1016/j.ejcts.2009.02.005.
PubMed 19307137
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain After VATS Surgery for Pneumothorax
- ClinicalTrials.gov ID
- NCT00969423
- Acronym / sponsor ID
- H-A-2009-054
- Conditions
- Pneumothorax
- Keywords
- persistent pain, neuropathic pain, Chronic Pain, VATS, Primary spontaneous pneumothorax patients
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to recruit
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2011 (estimated)
- First posted
- 1 Sep 2009 (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.
The study will investigate characteristics of chronic pain after VATS surgery with two different sizes of videoscopic equipment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 mm equipment | Experimental | Device: 5mm videoscope5 mm videoscopic equipment |
| 10 mm | Experimental | Device: 10mm videoscopeUse of standard 10 mm VATS equipment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- PSP
- Able to understand and give consent
- Can read
- Residing in Denmark
Key exclusion criteria (8 listed)
- Unable to understand the written information in Danish
- Abuse (Medicine, Drugs, Alcohol)
- Severe psychiatric Illness
- Conflicting neurological disease
- Conversion to open surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5mm videoscopeuse of 5mm videoscope | Device | 5 mm equipment |
| 10mm videoscopeuse of 10mm videoscope | Device | 10 mm |
Primary outcome
QST score
Time frame: 2 years
Post surgical pain
Time frame: 2 years
1 secondary outcome
Patient related factors, depression, coping etc.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: unable to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2011.
- Background: PubMed 19307137Wildgaard K, Ravn J, Kehlet H. Chronic post-thoracotomy pain: a critical review of pathogenic mechanisms and strategies for prevention. Eur J Cardiothorac Surg. 2009 Jul;36(1):170-80. doi: 10.1016/j.ejcts.2009.02.005.
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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.
Kim Wildgaard, MD principal investigator
Section for Surgical Pathophysiology 4074 Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5mm videoscope and 10mm videoscope in people with Pneumothorax, 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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 18 Aug 2011. 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?
The study was stopped early (reason given: unable to recruit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QST score (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00969423, which also lists 1 linked publication.
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 18 Aug 2011.