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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01692392

Acronym

HRQoL

Enrollment

Registered

2012-09-25

Start date

2012-09-30

Completion date

2013-11-30

Last updated

2014-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Pectus Carinatum, Quality of Life, Somatosensory Disorders

Keywords

Pectus carinatum, Quality of life, Pain, postoperative, Somatosensory disorders

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

10 Years to 55 Years

Healthy volunteers

Inclusion criteria

* all patients undergoing surgery for pectus carinatum

Exclusion criteria

* patients without pectus carinatum

Design outcomes

Primary

Measure	Time frame	Description
Change from Baseline in health-related quality of life at 6 months	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

Measure	Time frame	Description
Persistent post-surgical pain	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.

Countries

Denmark

Outcome results