Clinical Trial: Short and Long-term Effects of Surgical Repair of Pectus Deformities

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Observational

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

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 Summary:
Sponsor: University of Aarhus

Current 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).



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: University of Aarhus

Dates:
Date Received: April 4, 2011
Date Started: September 2015
Date Completion: December 2015
Last Updated: May 31, 2015
Last Verified: June 2012