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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2012 by University of Aarhus
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
  Purpose

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.


Condition Intervention
Pain, Postoperative
Procedure: Minimally invasive repair of pectus excavatum
Procedure: Open surgical repair of pectus carinatum

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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).



Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1000
Study Start Date: December 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: Ravitch procedure

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329120

Contacts
Contact: Kasper Grosen, PhD Fellow +4589495443 kasper.grosen@ki.au.dk
Contact: Hans K Pilegaard, MD +4589495403 pilegaard@dadlnet.dk

Locations
Denmark
Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vascular Surgery Recruiting
Aarhus, Denmark, 8200
Contact: Kasper Grosen, PhD Fellow    +4589495443    kasper.grosen@ki.au.dk   
Contact: Hans K Pilegaard, MD    +4589495403    pilegaard@dadlnet.dk   
Principal Investigator: Kasper Grosen, PhD Fellow         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01329120     History of Changes
Other Study ID Numbers: MIRPEX-1
Study First Received: April 4, 2011
Last Updated: August 4, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014