Mapping Recovery, Quality of Life, and Physical Function After Partial and Radical Nephrectomy
Aim:
To investigate recovery, quality of life, and physical function before and after partial or radical nephrectomy.
To validate the Quality of Recovery-15 (QoR-15) questionnaire in a urological cohort and investigate whether the questionnaire can be used to identify differences in patient-reported recovery across patient populations.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Herlev, Dinamarca, 2730
- Recrutamento
- Department of Urology, Copenhagen University Hospital Herlev and Gentofte
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Contato:
- Marie Juul-Haslund, MD
- Número de telefone: 004538682699
- E-mail: marie.juul-haslund@regionh.dk
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
All patients >18 years scheduled for radical or partial nephrectomy
Descrição
Inclusion criteria
- Scheduled for radical or partial nephrectomy (all surgical approaches).
- Benign or malignant indication for surgery.
- Age >18 years. Exclusion criteria
- Unable to read Danish.
- Unable to complete the questionnaire.
- Emergency surgery.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in quality of recovery from enrollment to outpatient follow-up 21 days after surgery
Prazo: From enrollment to the end of follow up 21 days after surgery
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Quality of recovery is evaluated with the danish translation of the verified questionnaire Quality of Recovery-15. It is a 15-item patient questionnaire, where the score ranges from 0-150. A higher score indicates better patient-reported quality of recovery. QoR-15 will be assessed preoperatively, and 1, 2, 7 and 21 days after surgery. Change in QoR-15 from enrollment to 21 days after surgery is the primary outcome measure. Change in QoR-15 at other assessment times will be assessed as secondary outcome measures. |
From enrollment to the end of follow up 21 days after surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Quality of Recovery at other predefined time points.
Prazo: Multiple times from enrollment to outpatient follow-up at 21 days after surgery
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Quality of recovery is measured by the danish translation of the verified questionnaire Quality of Recovery-15. It is a 15-item patient questionnaire, where the score ranges from 0-150. A higher score indicates better patient-reported quality of recovery. QoR-15 will be assessed at preoperatively, and 1, 2, 7 and 21 days after surgery. |
Multiple times from enrollment to outpatient follow-up at 21 days after surgery
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Change in quality of life assessed using the EQ-5D-5L
Prazo: From enrollment to the end of follow up 21 days after surgery
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Quality of life is evaluated with the danish translation of the validated questionnaire EQ-5D-5L. The questionnaire evalutes five health dimensions (mobility, self-care, usual acitivites, pain/discomfort, anxiety/depression) ranging from "no problems" to "unable/ extreme problems". Additionally, it includes a visual analog scale scoring from 0-100, reflecting the participants overall self-reported health state. A higher score indicates a better patient-reported quality of life. Quality of life will be assessed preoperatively and 21 days after surgery. |
From enrollment to the end of follow up 21 days after surgery
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Physical function assessed using the 30 second sit to stand, handgrip strength and 6 minute walking test.
Prazo: From enrollment to the end of follow up, 21 days after surgery
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Physical function assessed using the 30 second sit to stand test (number of repetitions in 30s), handgrip strength test (maximum voluntary muscle strength in kg) and 6 minute walking test (distance in meters). The higher the test results, the better, for all tests. The tests are performed preoperatively and 21 days after surgery. |
From enrollment to the end of follow up, 21 days after surgery
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Validation parameters for the Quality of Recovery-15.
Prazo: From enrollment to the end of follow up, 21 days after surgery
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An evaluation of validity, reliability, responsiveness and feasibility of the Quality of Recovery-15, assessed preoperatively, and 1, 2, 7 and 21 days after surgery. |
From enrollment to the end of follow up, 21 days after surgery
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- F-26022406
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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