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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01329120
• Other study ID #: MIRPEX-1
• Status: Not yet recruiting
• Phase: N/A
• First received: April 4, 2011
• Last updated: May 31, 2015
• Start date: September 2015
• Est. completion date: December 2015

Study information

• Verified date: June 2012
• Source: University of Aarhus
• Contact: Kasper Grosen, PhD Fellow
• Phone: +4589495443
• Email: kasper.grosen[@]ki.au.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• 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
• Open surgical repair of pectus carinatum
Open surgical removal the affected cartilages bilaterally and the excess cartilage over the sternum

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vascular Surgery	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistent post-surgical pain	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	No
Secondary	Health related quality of life	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	No
Secondary	Patient satisfaction	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	No
Secondary	Aesthetic outcome	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	No