Health-related Quality of Life in Patients Undergoing Surgery for Pectus Carinatum (HRQoL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01692392
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : August 5, 2014
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
The purpose of the study is to assess changes in health-related quality of life in patients undergoing surgical correction of pectus carinatum. In addition, the study assessed long-term effects of surgical intervention in relation to the development of persistent postoperative pain and / or sensory disturbances in the surgical field.

Condition or disease
Pectus Carinatum Quality of Life Pain, Postoperative Somatosensory Disorders

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Short and Long-term Effects of Surgical Repair of Pectus Carinatum - A Questionnaire Study of Health-related Quality of Life, Persisten Post-surgical Pain and Sensory Disturbances.
Study Start Date : September 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Pectus carinatum
Patients who have undergone surgical repair of pectus carinatum.

Primary Outcome Measures :
  1. Change from Baseline in health-related quality of life at 6 months [ Time Frame: From baseline (the day before surgery) to six month follow-up (six months after 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)

Secondary Outcome Measures :
  1. Persistent post-surgical pain [ Time Frame: Six month following surgery ]
    In this study persistent post-surgical pain is defined as pain developing after pectus surgery and lasting for at least 4 months. Other causes of pain (e.g. infection) and pain continuing from a pre-existing pain problem will be excluded.

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Ages Eligible for Study:   10 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients referred to the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby for the purpose of surgery for pectus carinatum from May 1, 2012 to May 1, 2013 are invited to participated in the study

Inclusion Criteria:

  • all patients undergoing surgery for pectus carinatum

Exclusion Criteria:

  • patients without pectus carinatum

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01692392

Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vacular Surgery
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
University of Aarhus

Responsible Party: University of Aarhus Identifier: NCT01692392     History of Changes
Other Study ID Numbers: PECCAR-1
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: September 2012

Keywords provided by University of Aarhus:
Pectus carinatum
Quality of life
Pain, postoperative
Somatosensory disorders

Additional relevant MeSH terms:
Pain, Postoperative
Pectus Carinatum
Somatosensory Disorders
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Cartilage Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Connective Tissue Diseases
Sensation Disorders