Short and Long-term Effects of Surgical Repair of Pectus Deformities

Tracking Information
First Submitted Date	April 4, 2011
First Posted Date	April 5, 2011
Last Update Posted Date	June 2, 2015
Study Start Date	September 2015
Estimated Primary Completion Date	December 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: April 4, 2011)	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).
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01329120 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: April 4, 2011)	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.
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Short and Long-term Effects of Surgical Repair of Pectus Deformities
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
Brief 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. 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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
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.
Condition	Pain, Postoperative
Intervention	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; 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
Study Groups/Cohorts	Pectus excavatum Patients who has undergone minimally invasive repair of pectus excavatum Intervention: Procedure: Minimally invasive repair of pectus excavatum; Pectus carinatum Patients who has undergone open surgical repair of pectus carinatum Intervention: Procedure: Open surgical repair of pectus carinatum
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Unknown status
Estimated Enrollment; (submitted: April 4, 2011)	1000
Original Estimated Enrollment	Same as current
Estimated Study Completion Date	December 2015
Estimated Primary Completion Date	December 2015 (Final data collection date for primary outcome measure)
Eligibility Criteria	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
Sex/Gender	Sexes Eligible for Study: All
Ages	7 Years and older (Child, Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Denmark
Removed Location Countries
Administrative Information
NCT Number	NCT01329120
Other Study ID Numbers	MIRPEX-1
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	University of Aarhus
Study Sponsor	University of Aarhus
Collaborators	Not Provided
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
PRS Account	University of Aarhus
Verification Date	June 2012