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中华腔镜泌尿外科杂志(电子版) ›› 2025, Vol. 19 ›› Issue (04) : 423 -428. doi: 10.3877/cma.j.issn.1674-3253.2025.04.005

临床研究

单孔机器人与腹腔镜在保留肾单位肾部分切除术的小样本随机对照研究
叶孙益, 彭鼎, 汪朔, 夏丹()   
  1. 310003 杭州,浙江大学医学院附属第一医院余杭院区泌尿外科
  • 收稿日期:2025-05-12 出版日期:2025-08-01
  • 通信作者: 夏丹
  • 基金资助:
    国家重点研发计划(2022YFC2407305); 浙江省"尖兵""领雁"研发攻关计划(2024C03198)

A randomized controlled trial comparing single-port robotic surgery and laparoscopic surgery for nephron-sparing partial nephrectomy

Sunyi Ye, Ding Peng, Shuo Wang, Dan Xia()   

  1. Department of Urology, Yuhang Campus, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China
  • Received:2025-05-12 Published:2025-08-01
  • Corresponding author: Dan Xia
引用本文:

叶孙益, 彭鼎, 汪朔, 夏丹. 单孔机器人与腹腔镜在保留肾单位肾部分切除术的小样本随机对照研究[J/OL]. 中华腔镜泌尿外科杂志(电子版), 2025, 19(04): 423-428.

Sunyi Ye, Ding Peng, Shuo Wang, Dan Xia. A randomized controlled trial comparing single-port robotic surgery and laparoscopic surgery for nephron-sparing partial nephrectomy[J/OL]. Chinese Journal of Endourology(Electronic Edition), 2025, 19(04): 423-428.

目的

比较术锐单孔机器人与迈瑞腹腔镜在保留肾单位肾部分切除术中的安全性及临床疗效。

方法

2022年2月至2022年8月在浙江大学医学院附属第一医院接受保留肾单位肾部分切除术的20例患者,通过随机分配进入术锐单孔机器人观察组(10例),迈瑞腹腔镜对照组(10例)。收集两组患者的基本资料(年龄、BMI、R.E.N.A.L.评分、手术入路、性别、高血压、糖尿病、心脑血管疾病)和围手术期资料(手术时间、出血量、热缺血时间、住院天数、术后病理、术前及术后不同时间点肌酐水平、术后疼痛视觉模拟量表(VAS)评分),采用卡方检验、Fisher精确检验、t检验及Mann-Whitney U检验对数据进行统计分析。

结果

两组患者在年龄、BMI、性别分布、R.E.N.A.L.评分、术前肌酐水平、高血压、糖尿病、心脑血管疾病等方面差异均无统计学意义(P>0.05)。单孔机器人组手术时间为198(83~264)min,腔镜组为143(83~245)min,差异有统计学意义(P=0.044)。单孔机器人组出血量为15(2~50)mL,显著少于腔镜组的50 (10~200)mL (P=0.005)。两组患者术后1 d血肌酐,腔镜组为(94.1±23.5)μmol/L,单孔机器人组为(74.0±19.6)μmol/L,差异有统计学意义(P=0.030)。两组患者手术热缺血时间、出院前及术后1个月血肌酐水平、术后不同时间点VAS评分、住院天数、术后并发症发生率方面差异均无统计学意义(P>0.05)。

结论

术锐单孔机器人在保留肾单位肾部分切除术中较国产迈瑞腹腔镜具有更少的出血量、术后对肾功能影响小、恢复快,且两种手术方式安全性相当。

Objective

To compare the clinical efficacy and safety of Shurui single-port robotic system (Shanghai Shurui Medical Technology Co., Ltd., China) versus Mindray laparoscopic system (China) in nephron-sparing partial nephrectomy.

Methods

From February to August 2022, 20 patients undergoing nephron-sparing partial nephrectomy at the First Affiliated Hospital of Zhejiang University School of Medicine, were randomly assigned to the Shurui single-port robotic group (n=10) or the Mindray laparoscopic control group (n=10). Demographic data (age, BMI, R.E.N.A.L. score, surgical approach, gender, hypertension, diabetes, cardiovascular and cerebrovascular diseases) and perioperative outcomes (operative time, blood loss, warm ischemia time, hospital stay, postoperative pathology, preoperative and postoperative creatinine levels, and visual analogue scale pain scores) were collected. Statistical analysis was performed using Chi-square test, Fisher’s exact test, t-test, and Mann-Whitney U test.

Results

There were no statistically significant differences between the two groups of patients in terms of age, BMI, gender distribution, R.E.N.A.L. score, preoperative creatinine level, hypertension, diabetes, cardiovascular and cerebrovascular diseases (P>0.05). The robotic group had longer operative time [198(83-264)] min vs 143(83-245) min, P=0.044] but lower blood loss [(15(2-50) mL vs 50 (10-200) mL, P=0.005]. Postoperative creatinine levels differed significantly only on postoperative day 1 [(74.0±19.6) μmol/L vs (94.1±23.5) μmol/L, P=0.030]. No statistically significant differences were observed between the two groups in terms of warm ischemia time during surgery, blood creatinine levels before discharge and one month after surgery, VAS scores at different time points after surgery, length of hospital stay, and the incidence of postoperative complications (P>0.05).

Conclusion

Shurui single-port robotic surgery demonstrated superior outcomes in reducing intraoperative blood loss and minimizing short-term renal function impairment compared to Mindray laparoscopy, with comparable safety profiles between the two approaches.

图1 术锐单孔机器人行保留肾单位的肾部分切除术套管布置及机械臂安装注:a为术锐机器人切口,分为主操作孔和辅助孔;b为器械臂安装完毕
图2 迈瑞腹腔镜行保留肾单位的肾部分切除术套管布置注:a为腹侧面,b为背侧面
表1 两组行肾部分切除术患者的基本资料比较
表2 两组行肾部分切除术患者围手术期资料比较
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