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

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.

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Key information

Conditions

Pectus Carinatum Bone Diseases Bone Diseases, Developmental Cartilage Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Quality of Life Sensation Disorders Signs and Symptoms Skin and Connective Tissue Diseases Somatosensory Disorders

Age range

10 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vacular Surgery

Aarhus, DK-8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

all patients undergoing surgery for pectus carinatum

Exclusion criteria

patients without pectus carinatum

Treatment and study plan

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study 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.

Acronym: HRQoL

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Sep 25, 2012
Registry last updated: Aug 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed