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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Herlev、デンマーク、2730
- 募集
- Department of Urology, Copenhagen University Hospital Herlev and Gentofte
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コンタクト：
- Marie Juul-Haslund, MD
- 電話番号：004538682699
- メール：marie.juul-haslund@regionh.dk
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
All patients >18 years scheduled for radical or partial nephrectomy
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in quality of recovery from enrollment to outpatient follow-up 21 days after surgery
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Quality of Recovery at other predefined time points.
時間枠：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
時間枠：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.
時間枠：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.
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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