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

• Conditions: Pain, Postoperative
• Interventions: Procedure: Minimally invasive repair of pectus excavatum; Procedure: Open surgical repair of pectus carinatum

• Registration Number: NCT01329120
• Lead Sponsor: University of Aarhus

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 available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2011-04-04
• Study First Submitted QC: 2011-04-04
• Study First Posted: 2011-04-05
• Status Verified: 2012-06
• Last Update Submitted: 2015-05-31
• Last Update Posted: 2015-06-02
• Study Start: 2015-09
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Minimally invasive repair of pectus excavatum from 2001 throughout 2010.
• Open surgical repair of pectus carinatum from 2001 throughout 2010.

Read More

Exclusion Criteria

• Not being able to fill in detailed questionnaires in Danish

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pectus excavatum	Minimally invasive repair of pectus excavatum	Patients who has undergone minimally invasive repair of pectus excavatum
Pectus carinatum	Open surgical repair of pectus carinatum	Patients who has undergone open surgical repair of pectus carinatum

Primary Outcome Measures

Name	Time	Method
Persistent post-surgical pain	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).

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	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.
Health related quality of life	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)
Aesthetic outcome	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.

Trial Locations

Locations (1)

Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vascular Surgery; 🇩🇰 Aarhus, Denmark