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.

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative
• Intervention / Treatment: Procedure: Minimally invasive repair of pectus excavatum; Procedure: Open surgical repair of pectus carinatum

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Kasper Grosen, PhD Fellow; Phone Number: +4589495443; Email: kasper.grosen@ki.au.dk
• Study Contact Backup: Name: Hans K Pilegaard, MD; Phone Number: +4589495403; Email: pilegaard@dadlnet.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vascular Surgery
    • Contact: Kasper Grosen, PhD Fellow; Phone Number: +4589495443; Email: kasper.grosen@ki.au.dk
    • Contact: Hans K Pilegaard, MD; Phone Number: +4589495403; Email: pilegaard@dadlnet.dk
    • Principal Investigator: Kasper Grosen, PhD Fellow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pectus excavatum; Patients who has undergone minimally invasive repair of pectus excavatum	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 Names: Nuss procedure
Pectus carinatum; Patients who has undergone open surgical repair of pectus carinatum	Procedure: Open surgical repair of pectus carinatum; Open surgical removal the affected cartilages bilaterally and the excess cartilage over the sternum; Other Names: Ravitch procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Aarhus
• 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

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: April 4, 2011
• First Submitted That Met QC Criteria: April 4, 2011
• First Posted (Estimate): April 5, 2011

Study Record Updates

• Last Update Posted (Estimate): June 2, 2015
• Last Update Submitted That Met QC Criteria: May 31, 2015
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: MIRPEX-1