Short and Long-term Effects of Surgical Repair of Pectus Deformities
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|ClinicalTrials.gov Identifier: NCT01329120|
Recruitment Status : Unknown
Verified June 2012 by University of Aarhus.
Recruitment status was: Not yet recruiting
First Posted : April 5, 2011
Last Update Posted : June 2, 2015
|Condition or disease||Intervention/treatment|
|Pain, Postoperative||Procedure: Minimally invasive repair of pectus excavatum Procedure: Open surgical repair of pectus carinatum|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|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|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
Patients who has undergone minimally invasive repair of pectus excavatum
Procedure: 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 Name: Nuss procedure
Patients who has undergone open surgical repair of pectus carinatum
Procedure: Open surgical repair of pectus carinatum
Open surgical removal the affected cartilages bilaterally and the excess cartilage over the sternum
Other Name: Ravitch procedure
- 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).
- 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)
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329120
|Contact: Kasper Grosen, PhD Fellowemail@example.com|
|Contact: Hans K Pilegaard, MDfirstname.lastname@example.org|
|Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vascular Surgery||Recruiting|
|Aarhus, Denmark, 8200|
|Contact: Kasper Grosen, PhD Fellow +4589495443 email@example.com|
|Contact: Hans K Pilegaard, MD +4589495403 firstname.lastname@example.org|
|Principal Investigator: Kasper Grosen, PhD Fellow|
|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|