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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
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Herlev, Danmark, 2730
- Rekruttering
- Department of Urology, Copenhagen University Hospital Herlev and Gentofte
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Kontakt:
- Marie Juul-Haslund, MD
- Telefonnummer: 004538682699
- E-mail: marie.juul-haslund@regionh.dk
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
All patients >18 years scheduled for radical or partial nephrectomy
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in quality of recovery from enrollment to outpatient follow-up 21 days after surgery
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Quality of Recovery at other predefined time points.
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- F-26022406
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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