Pain, PostoperativeNCT01329120
Short and Long-term Effects of Surgical Repair of Pectus Deformities
An observational study of Pain, Postoperative, run by University of Aarhus at 1 site in Denmark.
Trial summary
A large number of institutions have reported their early results with minimally invasive repair of pectus excavatum and open repair of pectus carinatum, but only few have addressed the outcomes relevant to the concerns of the patients and even fewer have reported long-term results following bar removal. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Minimally invasive repair of pectus excavatum and Open surgical repair of pectus carinatum
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2015to Dec 2015
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive patients referred to the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby for the purpose of pectus deformity repair from January 1, 2001 to December 31, 2010 are invited to participate in the study.
Who may be able to join
- Minimally invasive repair of pectus excavatum from 2001 throughout 2010.
- Open surgical repair of pectus carinatum from 2001 throughout 2010.
Who cannot join
- Not being able to fill in detailed questionnaires in Danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vascular Surgery
Aarhus, 8200
Kasper Grosen, PhD Fellow, +4589495443, kasper.grosen@ki.au.dk
Hans K Pilegaard, MD, +4589495403, pilegaard@dadlnet.dk
About this study
Official title: Short and Long-term Effects of Surgical Repair of Pectus Excavatum and Pectus Carinatum - A Questionnaire Study of Persistent Post-surgical Pain, Health-related Quality of Life, Patient Satisfaction, and Aesthetic Outcome
A large number of institutions have reported their early results with minimally invasive repair of pectus excavatum and open repair of pectus carinatum, but only few have addressed the outcomes relevant to the concerns of the patients and even fewer have reported long-term results following bar removal. Even fewer studies have investigated the prevalence and characteristics of long term persistent post-surgical pain following surgical repair of pectus deformities. The reasons as to why acute postoperative pain in some patients persists and becomes chronic whereas in others the pain dies down shortly after wound healing are largely unknown, and why some patients complain of loss of sensibility in wide regions of their chest following surgery also remains unclear.
- Conditions
- Pain, Postoperative
- Being tested
- Minimally invasive repair of pectus excavatum, Open surgical repair of pectus carinatum
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive repair of pectus excavatumProcedure or surgery
Also called Nuss procedure
Minimally invasive surgical technique basically consisting of inserting one or more convex steel bars under the sternum through small bilateral incisions in the thoracic wall
Open surgical repair of pectus carinatumProcedure or surgery
Also called Ravitch procedure
Open surgical removal the affected cartilages bilaterally and the excess cartilage over the sternum
| Study group | Role | What they receive |
|---|---|---|
| Pectus excavatum | Patients who has undergone minimally invasive repair of pectus excavatum Receives: Procedure: Minimally invasive repair of pectus excavatum | |
| Pectus carinatum | Patients who has undergone open surgical repair of pectus carinatum Receives: Procedure: Open surgical repair of pectus carinatum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent post-surgical pain
Persistent post-surgical pain is in this study defined as pain developing after pectus surgery and lasting for at least 4 months. Other causes of pain (e.g. infection and malignancy) and pain continuing from a pre-existing pain problem will be excluded.
Persistent post-surgical pain present at time of the study will be assessed by means of a specifically developed questionnaire including items from the Danish translation of the Brief Pain inventory (BPI-short form) and the Danish translation of the short version of the McGill Pain Questionnaire (SF-MPQ).
Measured: At least 4 months following surgery
Secondary outcomes (3)
Health related quality of life
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: At least 4 months following surgery
Patient satisfaction
Satisfaction with the result of the deformity repair and the perceived impact of the correction on health-related quality of life is assessed by means of questions about the emotional and practical consequences of, and satisfaction with pectus repair.
Measured: At least 4 months following surgery
Aesthetic outcome
In order to assess the surgical outcome following pectus repair in terms of aesthetic outcome more objectively, patients are encouraged to upload or e-mail a digital frontal image of their chests. Two thoracic surgeons, including the operating surgeon, and a research secretary are instructed to evaluate the breast symmetry, scars on the chest, and the overall cosmetic result of the repair.
Measured: At least 4 months following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study startSep 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kasper Grosen, PhD Fellow, Principal investigator, Aarhus University Hospital SkejbyHans K Pilegaard, MD, Study director, Aarhus University Hospital SkejbyMogens Pfeiffer-Jensen, MD, PhD, Study chair, Aarhus University Hospital, Aarhus SygehusVibeke E Hjortdal, Prof., MD, PhD, Study chair, Aarhus University Hospital Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329120
- Sponsor's protocol ID
- MIRPEX-1
- Status last verified
- Jun 2012
- First submitted
- 4 Apr 2011
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. 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 Excavatum and Pectus Carinatum - A Questionnaire Study of Persistent Post-surgical Pain, Health-related Quality of Life, Patient Satisfaction, and Aesthetic Outcome
- ClinicalTrials.gov ID
- NCT01329120
- Acronym / sponsor ID
- MIRPEX-1
- Conditions
- Pain, Postoperative
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 5 Apr 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.
A large number of institutions have reported their early results with minimally invasive repair of pectus excavatum and open repair of pectus carinatum, but only few have addressed the outcomes relevant to the concerns of the patients and even fewer have reported long-term results following bar removal. Even fewer studies have investigated the prevalence and characteristics of long term persistent post-surgical pain following surgical repair of pectus deformities. The reasons as to why acute postoperative pain in some patients persists and becomes chronic whereas in others the pain dies down shortly after wound healing are largely unknown, and why some patients complain of loss of sensibility in wide regions of their chest following surgery also remains unclear.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pectus excavatum | – | Procedure: Minimally invasive repair of pectus excavatumPatients who has undergone minimally invasive repair of pectus excavatum |
| Pectus carinatum | – | Procedure: Open surgical repair of pectus carinatumPatients who has undergone open surgical repair of pectus carinatum |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients referred to the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby for the purpose of pectus deformity repair from January 1, 2001 to December 31, 2010 are invited to participate in the study.
Key inclusion criteria (2 listed)
- Minimally invasive repair of pectus excavatum from 2001 throughout 2010.
- Open surgical repair of pectus carinatum from 2001 throughout 2010.
Key exclusion criteria (1 listed)
- Not being able to fill in detailed questionnaires in Danish
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 |
|---|---|---|
| Minimally invasive repair of pectus excavatumAlso: Nuss procedureMinimally invasive surgical technique basically consisting of inserting one or more convex steel bars under the sternum through small bilateral incisions in the thoracic wall | Procedure or surgery | Pectus excavatum |
| Open surgical repair of pectus carinatumAlso: Ravitch procedureOpen surgical removal the affected cartilages bilaterally and the excess cartilage over the sternum | Procedure or surgery | Pectus carinatum |
Primary outcome
Persistent post-surgical pain
Time frame: At least 4 months following surgery
Persistent post-surgical pain is in this study defined as pain developing after pectus surgery and lasting for at least 4 months. Other causes of pain (e.g. infection and malignancy) and pain continuing from a pre-existing pain problem will be excluded. Persistent post-surgical pain present at time of the study will be assessed by means of a specifically developed questionnaire including items from the Danish translation of the Brief Pain inventory (BPI-short form) and the Danish translation of the short version of the McGill Pain Questionnaire (SF-MPQ).
3 secondary outcomes
Health related quality of life
Time frame: At least 4 months following surgery
Patient satisfaction
Time frame: At least 4 months following surgery
Aesthetic outcome
Time frame: At least 4 months following surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
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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.
Kasper Grosen, PhD Fellow principal investigator
Aarhus University Hospital Skejby
Hans K Pilegaard, MD study director
Aarhus University Hospital Skejby
Mogens Pfeiffer-Jensen, MD, PhD study chair
Aarhus University Hospital, Aarhus Sygehus
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 Pain, Postoperative, 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 2 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: status not confirmed, as of the sponsor's last update on 2 Jun 2015. 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 Kasper Grosen, PhD Fellow (+4589495443, kasper.grosen@ki.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent post-surgical pain (time frame: At least 4 months following 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 2 Jun 2015.