NCT01692392

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

August 5, 2014

Status Verified

September 1, 2012

Enrollment Period

1.2 years

First QC Date

September 12, 2012

Last Update Submit

August 4, 2014

Conditions

Pectus CarinatumQuality of LifePain, PostoperativeSomatosensory Disorders

Keywords

Pectus carinatumQuality of lifePain, postoperativeSomatosensory disorders

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in health-related quality of life at 6 months

    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 Outcomes (1)

  • Persistent post-surgical pain

    Six month following surgery

Study Arms (1)

Pectus carinatum

Patients who have undergone surgical repair of pectus carinatum.

Eligibility Criteria

Age10 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • all patients undergoing surgery for pectus carinatum

You may not qualify if:

  • patients without pectus carinatum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Aarhus, DK-8000, Denmark

Location

MeSH Terms

Conditions

Pectus CarinatumPain, PostoperativeSomatosensory Disorders

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesCartilage DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsSensation DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2012

First Posted

September 25, 2012

Study Start

September 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

August 5, 2014

Record last verified: 2012-09

Locations

DK(1)