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机器人辅助腹腔镜与开放根治性膀胱切除术前瞻性随机临床试验的健康相关生活质量。

Health-related quality of life from a prospective randomised clinical trial of robot-assisted laparoscopic vs open radical cystectomy.

机构信息

Department of Urology, University of Texas Health Sciences Center at San Antonio, San Antonio, TX, USA.

出版信息

BJU Int. 2014 Dec;114(6):896-902. doi: 10.1111/bju.12818. Epub 2014 Aug 13.

Abstract

OBJECTIVE

To compare health-related quality-of-life (HRQoL) outcomes for robot-assisted laparoscopic radical cystectomy (RARC) with those of traditional open radical cystectomy (ORC) in a prospective randomised fashion.

PATIENTS AND METHODS

This was a prospective randomised clinical trial evaluating the HRQoL for ORC vs RARC in consecutive patients from July 2009 to June 2011. We administered the Functional Assessment of Cancer Therapy-Vanderbilt Cystectomy Index questionnaire, validated to assess HRQoL, preoperatively and then at 3, 6, 9 and 12 months postoperatively. Scores for each domain and total scores were compared in terms of deviation from preoperative values for both the RARC and the ORC cohorts. Multivariate linear regression was used to assess the association between the type of radical cystectomy and HRQoL.

RESULTS

At the time of the study, 47 patients had met the inclusion criteria, with 40 patients being randomised for analysis. The cohorts consisted of 20 patients undergoing ORC and 20 undergoing RARC, who were balanced with respect to baseline demographic and clinical features. Univariate analysis showed a return to baseline scores at 3 months postoperatively in all measured domains with no statistically significant difference among the various domains between the RARC and the ORC cohorts. Multivariate analysis showed no difference in HRQoL between the two approaches in any of the various domains, with the exception of a slightly higher physical well-being score in the RARC group at 6 months.

CONCLUSIONS

There were no significant differences in the HRQoL outcomes between ORC and RARC, with a return of quality of life scores to baseline scores 3 months after radical cystectomy in both cohorts.

摘要

目的

以前瞻性随机方式比较机器人辅助腹腔镜根治性膀胱切除术(RARC)与传统开放式根治性膀胱切除术(ORC)的健康相关生活质量(HRQoL)结局。

患者和方法

这是一项前瞻性随机临床试验,评估 2009 年 7 月至 2011 年 6 月连续患者中 ORC 与 RARC 的 HRQoL。我们使用功能评估癌症治疗-范德比尔特膀胱癌指数问卷进行评估,该问卷经过验证可评估 HRQoL,在术前以及术后 3、6、9 和 12 个月进行评估。比较 RARC 和 ORC 队列中每个领域的分数和总分与术前值的偏差。使用多元线性回归评估根治性膀胱切除术类型与 HRQoL 之间的关联。

结果

在研究时,有 47 名患者符合纳入标准,其中有 40 名患者被随机分配进行分析。队列包括 20 名接受 ORC 和 20 名接受 RARC 的患者,在基线人口统计学和临床特征方面平衡。单因素分析显示,所有测量领域的评分在术后 3 个月均恢复到基线水平,RARC 和 ORC 队列之间各领域之间无统计学差异。多因素分析显示,在任何领域,两种方法的 HRQoL 均无差异,除了 RARC 组在 6 个月时身体幸福感评分略高。

结论

ORC 和 RARC 之间的 HRQoL 结局没有显著差异,两组在根治性膀胱切除术后 3 个月时,生活质量评分均恢复到基线水平。

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