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

August 4, 2014 updated by: University of Aarhus

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.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • all patients undergoing surgery for pectus carinatum

Exclusion Criteria:

  • patients without pectus carinatum

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pectus carinatum
Patients who have undergone surgical repair of pectus carinatum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From baseline (the day before surgery) to six month follow-up (six months after surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Six month following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

September 20, 2012

First Posted (Estimate)

September 25, 2012

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PECCAR-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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