Quality-of-life outcomes of the ROBOtic-assisted versus Conventional Open Partial nephrectomy (ROBOCOP) II trial

被引:5
作者
Sidoti Abate, Marie Angela [1 ]
Menold, Hanna Saskia [1 ]
Neuberger, Manuel [1 ]
Kirchner, Marietta [2 ]
Haney, Caelan Max [3 ,4 ,5 ]
Nuhn, Philipp [1 ,6 ,7 ]
Westhoff, Niklas [1 ]
Honeck, Patrick [1 ]
Michel, Maurice-Stephan [1 ]
Kriegmair, Maximilian Christian [1 ,8 ]
Kowalewski, Karl-Friedrich [1 ,3 ,4 ]
机构
[1] Univ Med Ctr Mannheim, Heidelberg Univ, Dept Urol & Urol Surg, Theodor Kutzer Ufer 1-3, D-68167 Mannheim, Germany
[2] Heidelberg Univ, Inst Med Biometry, Heidelberg, Germany
[3] German Canc Res Ctr, Div Intelligent Syst & Robot Urol ISRU, Heidelberg, Germany
[4] Univ Med Ctr Mannheim, DKFZ Hector Canc Inst, Heidelberg, Germany
[5] Univ Leipzig, Dept Urol, Leipzig, Germany
[6] CAU, Dept Urol, Kiel, Germany
[7] UKSH Kiel, Kiel, Germany
[8] Dept Urol Munich Planegg, Planegg, Germany
关键词
kidney cancer; randomised controlled trial; robot-assisted-surgery; evidence-based medicine; partial nephrectomy; quality of life;
D O I
10.1111/bju.16407
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
ObjectivesTo comprehensively compare quality-of-life (QoL) outcomes between open partial nephrectomy (OPN) and robot-assisted PN (RAPN) from the randomised ROBOtic-assisted versus Conventional Open Partial nephrectomy (ROBOCOP) II trial, as QoL data comparing OPN and RAPN are virtually non-existent, especially not from randomised controlled trials (RCTs).Patients and MethodsThe ROBOCOP II was a single-centre, open-label RCT between OPN and RAPN. The pre-planned analyses of QoL outcomes are presented. Data were analysed descriptively in a modified intention-to-treat population.ResultsA total of 50 patients underwent surgery. At postoperative Day 90 (POD90), there was no significant difference for the Kidney Disease Quality of Life-Short Form questionnaire score (mean [sd] OPN 72 [20] vs RAPN 76 [15], P = 0.850), while there were advantages for RAPN in the subdomains of 'Pain' (P = 0.006) and 'Physical functioning' (P = 0.011) immediately after surgery. For the European Organisation for Research and Treatment of Cancer quality of life questionnaire 30-item core there were overall advantages directly after surgery (mean [sd] score OPN 63 [20] vs RAPN 75 [17], P = 0.031), as well as for the subdomains 'Fatigue' (P = 0.026), 'Pain' (P = 0.002) and 'Constipation' (P = 0.045) but no differences at POD90. There were no differences for the EuroQoL five Dimensions five Levels questionnaire at POD90 (mean [sd] score OPN 70 [22] vs RAPN 72 [17], P = 1.0) or at any other time point. Finally, no significant differences were found for the overall Convalescence and Recovery Evaluation questionnaire score at POD90 (mean [sd] OPN 84 [13] vs RAPN 86 [10], P = 0.818) but less pain in the RAPN group (P = 0.017) directly after surgery.ConclusionsPain and physical functioning as subdomains of QoL are improved after RAPN compared to OPN in the early postoperative course, while there are no differences anymore after 3 months.
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收藏
页码:434 / 441
页数:8
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