摘要
目的 评估国产机器人手术系统在普通外科手术中应用的安全性和有效性.方法 前瞻性单中心单臂探索性研究2022年6月至2023年10月在甘肃省人民医院采用图迈®内窥镜手术机器人系统治疗的54例患者的临床资料.主要研究终点为手术成功率,次要研究终点为术中出血量、手术时间、并发症、系统性能、住院天数.结果52例患者均成功完成机器人手术,2例甲状腺手术因出血转为开放,成功率96％,术中无器官损伤或死亡,未发生系统故障.手术类型包括胆囊切除术、胃癌根治术、结直肠癌根治术、腹股沟疝修补术、肝脏部分切除术、甲状腺全切除术及胆总管-空肠吻合术.结论 研究初步证实图迈®内窥镜手术机器人系统对普通外科疾病的常规手术治疗具有安全性和有效性.
Abstract
Objective To evaluate the safety and efficacy of the domestic robotic surgical system for general surgery.Methods A prospective single-center,single-arm exploratory study was conducted at Gansu Provincial People's Hospital from Jun 2022 to Oct 2023,enrolling 54 patients undergoing general surgery using domestically produced Toumai® Endoscopic Surgical Robotic System.The primary study endpoint was surgical success rate,and the secondary study endpoints were intraoperative bleeding,operative time,complications,system performance,hospitalization days.Results In this study,robotic surgery was successfully completed in 52 patients,and in 2 patients undergoing thyroid operation it was converted to open surgery due to bleeding,with a success rate of 96％,no organ injury or death during surgery,and no system failure.The types of surgery included cholecystectomy,radical gastric cancer resection,radical colorectal cancer resection,inguinal hernia repair,partial hepatectomy,total thyroidectomy and choledocho-jejunal anastomosis.Conclusion The study provides preliminary evidence of the safety and efficacy of the Toumai® Endoscopic Surgical Robotic System for the treatment of general surgical diseases.
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