ThoracotomyNCT00746213
Chronic Pain After Thoracotomy, an Incidence Study
An observational study of Thoracotomy and Chronic Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This is an investigation on the frequency of chronic pain after thoracotomy for lung cancer. Factors relating to the development of chronic pain are investigated. Questionnaire survey. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracotomy, Chronic Pain
- How many people
- 1,340 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2008to Sep 2008
- 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: Post thoracotomy patients after lung cancer in Denmark
Who may be able to join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This is an investigation on the frequency of chronic pain after thoracotomy for lung cancer. Factors relating to the development of chronic pain are investigated. Questionnaire survey.
- Conditions
- Thoracotomy, Chronic Pain
- Keywords
- Thoracotomy, Chronic Pain
- Medical subject headings
- Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and pain score
Measured: more than 6 months postoperative
Secondary outcomes (2)
Activity of daily life
Measured: >6 months
Analgesic consumption and pain treatment
Measured: >6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThoracotomyStudies 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
- Retrospective
- Enrolment
- 1,340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Lung Cancer Group, Aarhus University Hospital
- Investigators
- Henrik Kehlet, MD.Phd,Proff, Study chair, Section for Surgical Pathophysiology 4074
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746213
- Sponsor's protocol ID
- H-B-2008-059
- Other IDs
- 2007-58-0015
- Status last verified
- Jun 2009
- First submitted
- 30 Jul 2008
- Last updated
- 4 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain After Thoracotomy, an Incidence Study
- ClinicalTrials.gov ID
- NCT00746213
- Acronym / sponsor ID
- H-B-2008-059
- Conditions
- Thoracotomy, Chronic Pain
- Keywords
- Thoracotomy, Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,340 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Lung Cancer Group, Aarhus University Hospital
- Study start
- Jul 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 3 Sep 2008 (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 an investigation on the frequency of chronic pain after thoracotomy for lung cancer. Factors relating to the development of chronic pain are investigated. Questionnaire survey.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post thoracotomy patients after lung cancer in Denmark
Key inclusion criteria (3 listed)
- Able to understand and give consent
- Can read
- Residing in Denmark
Key exclusion criteria (4 listed)
- Unable to understand the written information in Danish
- Abuse (Medicine, Drugs, Alcohol)
- Severe psychiatric Illness
- Conflicting neurological disease
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
Pain and pain score
Time frame: more than 6 months postoperative
2 secondary outcomes
Activity of daily life
Time frame: >6 months
Analgesic consumption and pain treatment
Time frame: >6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2009.
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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.
Henrik Kehlet, MD.Phd,Proff study chair
Section for Surgical Pathophysiology 4074
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 Thoracotomy and Chronic Pain, 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 4 Jun 2009. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain and pain score (time frame: more than 6 months postoperative). 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 4 Jun 2009.