- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01329120
Short and Long-term Effects of Surgical Repair of Pectus Deformities
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
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Kasper Grosen, PhD Fellow
- Phone Number: +4589495443
- Email: kasper.grosen@ki.au.dk
Study Contact Backup
- Name: Hans K Pilegaard, MD
- Phone Number: +4589495403
- Email: pilegaard@dadlnet.dk
Study Locations
-
-
-
Aarhus, Denmark, 8200
- Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vascular Surgery
-
Contact:
- Kasper Grosen, PhD Fellow
- Phone Number: +4589495443
- Email: kasper.grosen@ki.au.dk
-
Contact:
- Hans K Pilegaard, MD
- Phone Number: +4589495403
- Email: pilegaard@dadlnet.dk
-
Principal Investigator:
- Kasper Grosen, PhD Fellow
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Minimally invasive repair of pectus excavatum from 2001 throughout 2010.
- Open surgical repair of pectus carinatum from 2001 throughout 2010.
Exclusion Criteria:
- Not being able to fill in detailed questionnaires in Danish
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pectus excavatum
Patients who has undergone minimally invasive repair of pectus excavatum
|
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
Other Names:
|
Pectus carinatum
Patients who has undergone open surgical repair of pectus carinatum
|
Open surgical removal the affected cartilages bilaterally and the excess cartilage over the sternum
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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). |
At least 4 months following surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health related quality of life
Time Frame: At least 4 months following 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)
|
At least 4 months following surgery
|
Patient satisfaction
Time Frame: At least 4 months following surgery
|
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.
|
At least 4 months following surgery
|
Aesthetic outcome
Time Frame: At least 4 months following surgery
|
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.
|
At least 4 months following surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kasper Grosen, PhD Fellow, Aarhus University Hospital Skejby
- Study Director: Hans K Pilegaard, MD, Aarhus University Hospital Skejby
- Study Chair: Mogens Pfeiffer-Jensen, MD, PhD, Aarhus University Hospital, Aarhus Sygehus
- Study Chair: Vibeke E Hjortdal, Prof., MD, PhD, Aarhus University Hospital Skejby
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MIRPEX-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain, Postoperative
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Bezmialem Vakif UniversityRecruitingPostoperative Pain ManagementTurkey
-
Pacira Pharmaceuticals, IncCompletedPostoperative Pain ManagementUnited States
Clinical Trials on Minimally invasive repair of pectus excavatum
-
Dr. Caroline FortmannFriedrich-Alexander-Universität Erlangen-NürnbergCompletedCongenital Funnel Chest
-
Poznan University of Physical EducationWielkopolska Centre of Pulmonology and Thoracic Surgery in PoznanCompleted
-
University Hospital, MontpellierRecruiting
-
Mayo ClinicActive, not recruitingNeural Tube Defects | Myelomeningocele | Spina BifidaUnited States
-
McGuire InstituteBiolase IncCompletedPeriodontal DiseasesUnited States
-
Eagle Pharmaceuticals, Inc.Quintiles, Inc.Completed
-
Texas A&M UniversityInstitut Straumann AGRecruitingPeriodontitis | Attachment Loss, PeriodontalUnited States
-
Ostfold Hospital TrustOslo University HospitalActive, not recruiting
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingOvarian Endometrioid Adenocarcinoma | Ovarian Clear Cell Adenocarcinoma | Fallopian Tube Transitional Cell Carcinoma | Ovarian Transitional Cell Carcinoma | Fallopian Tube Clear Cell Adenocarcinoma | Ovarian Serous Adenocarcinoma | Primary Peritoneal Serous Adenocarcinoma | Primary Peritoneal Clear... and other conditionsUnited States
-
Chang Gung Memorial HospitalCompletedBreast Reconstruction | Mastectomy; LymphedemaTaiwan