新型国产MP1000腹腔镜机器人手术的动物实验研究  

Animal experimental study of surgery with the new domestic EDGE MP1000 robot-assisted laparoscopic surgical system

作　　者：邓鹏瀚 刘艳燕 熊家强 陈雨柔 易跃雄[1] 张蔚[1] Deng Penghan;Liu Yanyan;Xiong Jiaqiang;Chen Yurou;Yi Yuexiong;Zhang Wei(Department of Obstetrics and Gynaecology,Zhongnan Hospital,Wuhan University,Wuhan 430071,China)

机构地区：[1]武汉大学中南医院妇科,武汉430071

出　　处：《中华实验外科杂志》2023年第4期700-703,共4页Chinese Journal of Experimental Surgery

基　　金：2022年度武汉大学中南医院转化医学及交叉学科研究联合基金(ZNJC202212);中央高校基本科研业务费专项资金资助(2042022kf1157)。

摘　　要：目的通过动物实验评价国产新型腹腔镜手术机器人系统(型号:EDGE MP1000)在妇科手术应用的安全性及有效性,为其后续临床试验提供基础。方法选取3~4月龄体重30~40 kg雌性西藏小型猪12只,按随机数表法分为机器人组和腹腔镜组,每组6只,分别使用国产新型腹腔镜手术机器人系统和传统腹腔镜系统进行全子宫切除术及淋巴结清扫术,统计并采用t检验分析两组的总手术时间、对接时间、子宫切除时间、阴道残端缝合时间、术中生命体征等数据,采用秩和检验分析术中出血量,并记录对比了中转率及术中并发症等情况,两组间比较采用t检验。结果所有手术操作均顺利完成,无中转开腹,无术中并发症发生。与传统腹腔镜手术组比较,机器人组出血减少[10.00(5.00,11.25)ml比20.00(12.50,27.50)ml,Z=-2.049,P<0.05],子宫切除[(31.5±4.57)min比(56.5±3.82)min,t=-9.382,P<0.05]、缝合[(3.83±0.69)min比(7.50±0.96)min,t=-6.957,P<0.05]及淋巴结清扫[(16.00±2.38)min比(29.33±3.15)min,t=-7.559,P<0.05]耗时机器人组均低于腹腔镜组,差异具有统计学意义,切除子宫重量[(409.83±44.48)g比(394.33±13.00)g,t=0.748,P>0.05]、总手术时间[(69.17±7.38)min比(70.83±4.71)min,t=-0.426,P>0.05]差异无统计学意义。术中监测生命体征平稳,术后未见明显术后并发症。结论国产EDGE MP1000腹腔镜手术机器人系统辅助的妇科手术在动物水平安全可行。Objective To evaluate the feasibility and safety of a new domestic robotic surgical system(EDGE MP1000)for gynecological surgery through animal experiment,providing a basis for the subsequent clinical trials.Methods A total of 12 female Tibet mini-pigs weighing 30-40 kg at 3-4 months of age were selected and divided into conventional laparoendoscopic surgery group(n=6)and robotic surgery group(n=6)according to the method of random number table.The total operation time,docking time,hysterectomy time,vaginal stump suture time,intraoperative vital signs and other data of the two groups were counted and analyzed by t test,while the intraoperative bleeding was analyzed by rank sum test,and the conversion rate and occurrence of intraoperative complications were recorded and compared.Results All surgical procedures were successfully completed,and no conversion to laparotomy or intraoperative complications occurred.Compared with the traditional laparoscopic surgery group,there was less bleeding[10.00(5.00,11.25)ml vs.20.00(12.50,27.50)ml,Z=-2.049,P<0.05],shorter hysterectomy time[(31.5±4.57)min vs.(56.5±3.82)min,t=-9.382,P<0.05],shorter suture time[(3.83±0.69)min vs.(7.50±0.96)min,t=-6.957]and shorter lymph node dissection time[(16.00±2.38)min vs.(29.33±3.15)min,t=-7.559]in the robotic group,with statistical significance(P<0.05),but no significant differences were found in the weight of hysterectomy[(409.83±44.48)g vs.(394.33±13.00)g,t=0.748,P>0.05]and total operation time[(69.17±7.38)min vs.(70.83±4.71)min,t=-0.426,P>0.05].The vital signs were stable during the operation and no significant postoperative complications were observed.Conclusion Gynecological surgery assisted by the domestic EDGE MP1000 robot-assisted laparoscopic surgical system is safe and feasible at the animal level,but it is still needed to be verified in the future clinical trials.

关 键 词：微创手术 机器人手术系统 全子宫切除术 淋巴结清扫术 

分 类 号：R713[医药卫生—妇产科学] R-332[医药卫生—临床医学]