Pectus CarinatumHRQoLNCT01692392
Health-related Quality of Life in Patients Undergoing Surgery for Pectus Carinatum
An observational study of Pectus Carinatum and Quality of Life, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of the study is to assess changes in health-related quality of life in patients undergoing surgical correction of pectus carinatum. In addition, the study assessed long-term effects of surgical intervention in relation to the development of persistent postoperative pain and / or sensory disturbances in the… Read more about this study
- Who is it for?
- Ages 10 to 55 years
- Conditions the study is for
- Pectus Carinatum, Quality of Life, Pain, Postoperative
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2012to Nov 2013
- 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 10 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients referred to the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby for the purpose of surgery for pectus carinatum from May 1, 2012 to May 1, 2013 are invited to participated in the study
Who may be able to join
- all patients undergoing surgery for pectus carinatum
Who cannot join
- patients without pectus carinatum
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vacular Surgery
Aarhus, DK-8000
About this study
Official title: Short and Long-term Effects of Surgical Repair of Pectus Carinatum - A Questionnaire Study of Health-related Quality of Life, Persisten Post-surgical Pain and Sensory Disturbances.
The purpose of the study is to assess changes in health-related quality of life in patients undergoing surgical correction of pectus carinatum. In addition, the study assessed long-term effects of surgical intervention in relation to the development of persistent postoperative pain and / or sensory disturbances in the surgical field.
- Keywords
- Pectus carinatum, Quality of life, Pain, postoperative, Somatosensory disorders
- Medical subject headings
- Pectus Carinatum, Pain, Postoperative, Somatosensory Disorders
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 |
|---|---|---|
| Pectus carinatum | Patients who have undergone surgical repair of pectus carinatum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in health-related quality of life at 6 months
Health-related Quality of Life (HRQoL) will be assessed by means of a validated Danish version of the Short-Form 36 Health Survey (SF-36)
Measured: From baseline (the day before surgery) to six month follow-up (six months after surgery)
Secondary outcomes (1)
Persistent post-surgical pain
In this study persistent post-surgical pain is defined as pain developing after pectus surgery and lasting for at least 4 months. Other causes of pain (e.g. infection) and pain continuing from a pre-existing pain problem will be excluded.
Measured: Six month following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus CarinatumStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692392
- Sponsor's protocol ID
- PECCAR-1
- Acronym
- HRQoL
- Status last verified
- Sep 2012
- First submitted
- 12 Sep 2012
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long-term Effects of Surgical Repair of Pectus Carinatum - A Questionnaire Study of Health-related Quality of Life, Persisten Post-surgical Pain and Sensory Disturbances.
- ClinicalTrials.gov ID
- NCT01692392
- Acronym / sponsor ID
- HRQoL / PECCAR-1
- Keywords
- Pectus carinatum, Quality of life, Pain, postoperative, Somatosensory disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 25 Sep 2012 (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 purpose of the study is to assess changes in health-related quality of life in patients undergoing surgical correction of pectus carinatum. In addition, the study assessed long-term effects of surgical intervention in relation to the development of persistent postoperative pain and / or sensory disturbances in the surgical field.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pectus carinatum | – | –Patients who have undergone surgical repair of pectus carinatum. |
Who may qualify
- Ages
- 10 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients referred to the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby for the purpose of surgery for pectus carinatum from May 1, 2012 to May 1, 2013 are invited to participated in the study
Key inclusion criteria (1 listed)
- all patients undergoing surgery for pectus carinatum
Key exclusion criteria (1 listed)
- patients without pectus carinatum
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
Change from Baseline in health-related quality of life at 6 months
Time frame: From baseline (the day before surgery) to six month follow-up (six months after surgery)
Health-related Quality of Life (HRQoL) will be assessed by means of a validated Danish version of the Short-Form 36 Health Survey (SF-36)
1 secondary outcome
Persistent post-surgical pain
Time frame: Six month following surgery
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 5 Aug 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pectus Carinatum and Quality of Life, run by University of Aarhus 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 1 inclusion and 1 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 5 Aug 2014. 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?
Change from Baseline in health-related quality of life at 6 months (time frame: From baseline (the day before surgery) to six month follow-up (six months after surgery)). 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 Aug 2014.