Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Aarhus.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01329120
First received: April 4, 2011
Last updated: August 4, 2014
Last verified: June 2012
History of Changes

April 4, 2011
August 4, 2014
December 2014
December 2014   (final data collection date for primary outcome measure)
Persistent post-surgical pain [ Time Frame: At least 4 months following surgery ] [ Designated as safety issue: No ]

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).
Same as current
Complete list of historical versions of study NCT01329120 on ClinicalTrials.gov Archive Site
  • Health related quality of life [ Time Frame: At least 4 months following surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

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.
Pain, Postoperative
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1000
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
7 Years and older
No
Contact: Kasper Grosen, PhD Fellow +4589495443 kasper.grosen@ki.au.dk
Contact: Hans K Pilegaard, MD +4589495403 pilegaard@dadlnet.dk
Denmark
 
NCT01329120
MIRPEX-1
No
University of Aarhus
University of Aarhus
Not Provided
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
University of Aarhus
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP