Quality of Life 12 Months After Cardiac Surgery

Study Overview
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Brief Summary
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Cardiac surgical patients entering the hospital for operation were voluntarily recruited to participate a 12 month follow- up of health related quality of life (QOL)

Detailed Description
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Cardiac surgical patients entering the hospital for operation were voluntarily recruited to participate a 12 month follow- up of health related quality of life based on established QOL measurements with EuroQol quality of life 5 dimensional 3 level (EQ-5D-3L) description system at preoperative, 6 months and 12 months postoperatively. The study started on May 2013 and ended at the end of 2018. The data has been analyzed for publication in 2021. The total number of patients reached 1594.

Official Title
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Quality of Life 12 Months After Cardiac Surgery

Conditions
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Quality of Life

Intervention / Treatment
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* Procedure: Cardiac surgical operation (valve, aorta, coronary arteries)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective or urgent cardiac surgery (open heart procedure to valves or ascending aorta /arch, on-pump or off-pump surgery to the coronary arteries ) willingness to participate, ability to comprehend Finnish language Exclusion Criteria: emergency surgery (with no time to introduce the study in good time) not willing to participate, blind or other disturbance in seeing, inability to comprehend Finnish language

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cardiac surgical operation (valve, aorta, coronary arteries)|Quality of life assessment using EQ-5D-3L|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-Visual Analogue Scale result, preoperative | EQ-Visual Analogue Scale, scale 0 (worst) to 100 (best possible), in percent | preoperative | 
| EQ-Visual Analogue Scale result, at 6 months | EQ-Visual Analogue Scale, scale 0 (worst) to 100 (best possible), in percent | 6 months after surgery | 
| EQ-Visual Analogue Scale result, at 12 months | EQ-Visual Analogue Scale, scale 0 (worst) to 100 (best possible), in percent | 12 months after surgery | 
| Results of preoperative Quality of life dimensions | 5 dimensions measurable with EQ5D-3L (scale 1,2 or 3) (ordinal scale) | preoperative | 
| Results of Quality of life dimensions at 6 months after surgery | 5 dimensions measurable with EQ5D-3L (scale 1,2 or 3)(ordinal scale) | 6 months after surgery | 
| Results of Quality of life dimensions at 12 months after surgery | 5 dimensions measurable with EQ5D-3L (scale 1,2 or 3)(ordinal scale) | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality rate | Survival after surgery, annual postoperative, in percent | over the follow-up period ranging 3 to 9 years postoperatively | 
| Overall surgical morbidity rate | All surgical and cardiovascular complications, in percent | 0 to 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Life, postoperative