ROBOCOP II 试验：机器人辅助与传统开放性部分肾切除术的生活质量结局比较。

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

机构信息

Department of Urology and Urological Surgery, University Medical Centre Mannheim, University of Heidelberg, Mannheim, Germany.

Institute of Medical Biometry, University of Heidelberg, Heidelberg, Germany.

出版信息

BJU Int. 2024 Sep;134(3):434-441. doi: 10.1111/bju.16407. Epub 2024 May 30.

DOI:10.1111/bju.16407

PMID:38816992

Abstract

OBJECTIVES

To 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 METHODS

The 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.

RESULTS

A 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.

CONCLUSIONS

Pain 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.

摘要

目的

全面比较开放部分肾切除术（OPN）和机器人辅助肾部分切除术（RAPN）的生活质量（QoL）结局，来自随机 ROBOtic 辅助与传统开放部分肾切除术（ROBOCOP） II 试验，因为比较 OPN 和 RAPN 的 QoL 数据几乎不存在，特别是没有随机对照试验（RCT）。

患者和方法

ROBOCOP II 是一项 OPN 和 RAPN 之间的单中心、开放标签 RCT。呈现了 QoL 结局的预设分析。在改良意向治疗人群中进行了描述性数据分析。

结果

共有 50 例患者接受了手术。在术后第 90 天（POD90），肾脏病生活质量-短表评分（OPN 为 72[20]，RAPN 为 76[15]，P=0.850）无显著差异，而 RAPN 在术后即刻的“疼痛”（P=0.006）和“身体机能”（P=0.011）亚域具有优势。对于欧洲癌症研究和治疗组织 30 项核心生活质量问卷，术后即刻总体上具有优势（OPN 评分 63[20]，RAPN 评分 75[17]，P=0.031），以及“疲劳”（P=0.026）、“疼痛”（P=0.002）和“便秘”（P=0.045）亚域，但在 POD90 时无差异。在 POD90 时欧洲五维健康量表五水平问卷（OPN 评分 70[22]，RAPN 评分 72[17]，P=1.0）或任何其他时间点均无差异。最后，在 POD90 时总体恢复和康复评估问卷评分（OPN 评分 84[13]，RAPN 评分 86[10]，P=0.818）无显著差异，但 RAPN 组术后即刻疼痛较轻（P=0.017）。