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This study compares clinical, self- reported and cost outcomes in children and adolescents treated with pulmonary valve implantation, percutaneous versus open surgical technique. Since cardiac surgery in children and adolescents affect the whole family, the experience of the patients and their closest relatives are recorded and analysed separately. Cost may be an important factor in the choice of technology (1). Hence, the present study also aims to compare savings in costs, percutaneous versus open technique, related to the individual, their family and society.
1.2 Research questions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| quality of life, clinical outcomes and costs | Other | Quality of life, clinical outcomes and costs after two different treatment options in patients and closest relatives |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous pulmonary valve implantation or open heart surgery | Procedure | Outcomes before percutaneous pulmonary valve implantation or open heart surgery before, 1, 3, 6 and 12 months after the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Percutaneous pulmonary valve implantation or open heart surgery; what are the patients and their closest relatives narrative experiences. Measured before the event, 1, 3, 6, and 12 month's after treatment. | up to 12 month's after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcomes | What is the relationship between patient reported outcomes and clinical outcomes before, 1, 3, 6 and 12 months after the treatment Is there a difference in the effect of percutaneous versus open surgical technique on operative time, complication rate and reoperations in the peri- and postoperative period? | up to 12 months after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brith Andresen, Can san | Contact | +4723070162 | brith.andresen@oslo-universitetssykehus.no | |
| Erik Fosse, Professor/Head of Department | Contact | +4723070116 | erik.fosse@oslo-universitetssykehus.no |
| Name | Affiliation | Role |
|---|---|---|
| Erik Fosse, Professor/Head of Department | The Interventional Centre, Rikshospitalet, Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Interventional Centre, Rikshospitalet, Oslo University Hospital | Recruiting | Oslo | Sognsvannsvn 20 | 0027 | Norway |
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| Are there savings in costs related to the individual and their family and society between the two techniques? | In order to describe and compare the differences in costs with patients outcomes and quality-adjusted life years, this study aim to calculate both in-hospital care and out-patient clinical costs between percutaneous pulmonary valve implantation and conventional open heart surgery. Measured Before the event, 1, 3, 6 and 12 months after surgery. | up to 12 months after surgery |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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