国产机器人手术系统辅助腹腔镜阴道骶骨固定术的安全性评价 一项单中心、小规模、单臂研究  

Safety evaluation of Chinese-made robot-assisted laparoscopic sacrocolpopexy:a single-center,small-scale,single-arm study

作　　者：张蕾[1] 王潇潇 王晓庆 张勤英 张丽慧 黄艳[1] 陆叶[1] Zhang Lei;Wang Xiaoxiao;Wang Xiaoqing;Zhang Qinying;Zhang Lihui;Huang Yan;Lu Ye(Department of Obstetrics and Gynecology,Peking University First Hospital,Beijing 100034,China)

机构地区：[1]北京大学第一医院妇产科,北京100034

出　　处：《中华妇产科杂志》2025年第3期183-192,共10页Chinese Journal of Obstetrics and Gynecology

基　　金：中央高水平医院临床科研业务费-北京大学第一医院青年临床研究专项(2023YC20)。

摘　　要：目的分析使用国产机器人手术系统进行腹腔镜阴道骶骨固定术治疗重度盆腔器官脱垂的安全性。方法采用探索性描述性临床研究,2023年4月至2024年1月在北京大学第一医院入组重度盆腔器官脱垂患者16例。同意入组的患者使用国产手术机器人腹腔内窥镜手术系统进行腹腔镜阴道骶骨固定术。收集患者的术前基本资料及围手术期资料,总结手术时间、术中出血量、住院时间及并发症等数据,并对手术学习经验进行总结,学习经验的评价指标包括:(1)效率评价:包括设备对接时间、总手术时间、机械臂缝合时间、机械臂操作时间、子宫切除时间,术中计时并记录;(2)设备操作性评价:包括设备操作任务负荷评估和术中操作感受评分。使用累积求和分析法量化相关指标时间并拟合学习曲线。结果16例患者成功入组并完成手术,年龄为(56.7±7.6)岁(范围:44~67岁),体重指数为(25.4±2.5)kg/m 2;手术方式为机器人手术系统辅助腹腔镜阴道骶骨固定+子宫全切除+双侧附件或双侧输卵管切除术、或者单纯阴道骶骨固定术(针对1例无子宫者),其中,同时行阴道前壁修补术12例(12/16)、阴道后壁修补术13例(13/16)、经闭孔尿道中段无张力悬吊带术1例、直肠子宫陷凹疝修补术4例(4/16)。总手术时间为(355.8±91.1)min,设备对接时间为(6.7±4.9)min,机械臂操作时间(267.6±81.4)min,机械臂缝合时间(155.6±53.9)min,子宫切除时间(112.0±45.3)min。学习曲线拟合显示,总手术时间的曲线拐点为第6例(P<0.001,拟合优度R^(2)=0.944),机械臂操作时间曲线拐点也为第6例(P<0.001,拟合优度R^(2)=0.982),设备对接时间曲线拐点为第5例(P<0.001,拟合优度R^(2)=0.989),机械臂缝合时间曲线拐点为第6例(P<0.001,拟合优度R^(2)=0.907),子宫切除时间曲线拐点为第5例(P=0.023,拟合优度R^(2)=0.700)。中位术中出血量30 ml(范围:10~1000 ml),严重出血1例(1/16),无中转�ObjectiveTo describe the safety of using the Chinese-made robotic laparoscopic surgery system for laparoscopic sacrocolpopexy in the treatment of severe pelvic organ prolapse.MethodsA pilot descriptive clinical study was conducted,enrolling 16 severe pelvic organ prolapse patients at Peking University First Hospital from April 2023 to January 2024.Patients who consented to participate in this study underwent laparoscopic sacrocolpopexy for severe pelvic organ prolapse using Chinese-made robotic laparoscopic surgery system.Preoperative clinical basic data and perioperative data of the patients were collected,summarizing the data on perioperative bleeding and complications,and reviewed the surgical learning experience.The evaluation indicators related to the learning experience included:(1)efficiency evaluation:including equipment docking time,total surgery time,suturing time,mechanical arm operation time and hysterectomy time,which were timed and recorded during surgery;(2)equipment operability evaluation:including equipment operation task load assessment and intraoperative operation feeling score.The cumulative sum analysis method was used to quantify surgery time and fit the learning curve.ResultsSixteen patients were successfully enrolled and underwent surgery,including total hysterectomy with bilateral salpingo-oophorectomy or salpingectomy plus sacrocolpopexy,or sacrocolpopexy alone(for one case without uterus).The age of 16 cases was(56.7±7.6)years(ranged from 44 to 67 years),with body mass index of(25.4±2.5)kg/m².Concurrent procedures included anterior vaginal wall repair in 12 cases(12/16),posterior vaginal wall repair in 13 cases(13/16),tension-free vaginal tape obturator system in 1 case(1/16),and recto-uterine pouch hernia repair in 4 cases(4/16).The total surgery time was(355.8±91.1)minutes,with docking time at(6.7±4.9)minutes,robotic operative time at(267.6±81.4)minutes,robotic suturing time at(155.6±53.9)minutes,and hysterectomy time at(112.0±45.3)minutes.Learning curve analysis revealed infl

关 键 词：盆腔器官脱垂 机器人手术 腹腔镜检查 妇科外科手术 骶骨 阴道 学习曲线 

分 类 号：R713[医药卫生—妇产科学]