Completed

HRQoLShort 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.

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Congenital Abnormalities+17

+ Bone Diseases

+ Bone Diseases, Developmental

From 10 to 55 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2012
See protocol details

Summary

Principal SponsorUniversity of Aarhus
Last updated: August 5, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01692392
Principal SponsorUniversity of Aarhus
Last updated: August 5, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

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

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 10 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesBone DiseasesBone Diseases, DevelopmentalCartilage DiseasesConnective Tissue DiseasesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesNeurologic ManifestationsPainPathologic ProcessesPostoperative ComplicationsSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsSkin and Connective Tissue DiseasesPain, PostoperativeSomatosensory DisordersPectus Carinatum

Criteria

1 inclusion criteria required to participate
all patients undergoing surgery for pectus carinatum
1 exclusion criteria prevent from participating
patients without pectus carinatum

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

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

Aarhus, DenmarkOpen Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vacular Surgery in Google Maps
CompletedOne Study Center