国产单孔机器人手术系统用于经腹膜外泌尿外科手术的安全性和效果研究  

Safety and efficacy of domestic single-port robotic surgery system for extraperitoneal urological surgery

作　　者：彭鼎 景泰乐[1] 叶孙益[1] 姚晓霖[1] 徐鑫 何安邦 梁臻[1] 来翀[1] 祁洪刚 孟宏舟[1] 王平[1] 汪朔[1] 夏丹[1] Peng Ding;Jing Taile;Ye Sunyi;Yao Xiaolin;Xu Xin;He Anbang;Liang Zhen;Lai Chong;Qi Honggang;Meng Hongzhou;Wang Ping;Wang Shuo;Xia Dan(Department of Urology,The First Affiliated Hospital School of Medicine,Zhejiang University,Hangzhou 310003,China)

机构地区：[1]浙江大学医学院附属第一医院泌尿外科,杭州310003

出　　处：《中华泌尿外科杂志》2022年第8期581-586,共6页Chinese Journal of Urology

摘　　要：目的探讨国产单孔机器人手术系统在经腹膜外途径泌尿外科手术中应用的安全性和有效性。方法前瞻性纳入2022年2—4月浙江大学医学院附属第一医院需行腹腔镜根治性前列腺切除术、肾部分切除术和肾上腺肿物切除术患者。纳入标准:年龄≥18周岁;体质指数(BMI)18.5~30.0 kg/m^(2);美国麻醉医师协会(ASA)评分1~3分;能配合完成方案规定的访视和相关检查,自愿参加临床试验,本人或监护人签署知情同意书;肿瘤指标符合以下手术指征之一,前列腺癌分期≤T2b期,术前前列腺特异性抗原(PSA)≤20 ng/ml,Gleason评分≤7分;肾肿瘤分期为T1期,单发,肿瘤最大径≤4 cm;肾上腺肿瘤直径≤7 cm,如为无功能性肾上腺腺瘤,肿瘤直径≥3 cm。排除标准:存在其他恶性肿瘤或既往有其他恶性肿瘤病史,且研究者认为不适合纳入本研究者;既往接受过同类型泌尿系统外科手术治疗,且研究者评估不适合参与本研究者;入组前3个月内或计划在试验期间进行其他大型手术治疗者,或无法从任何此类手术并发症中恢复者;梅毒、乙肝、HIV感染及携带者;长期服用抗凝药或有血液系统疾病;试验期间无法有效避孕,或其他研究者认为不宜参加本试验的情况。国产单孔机器人手术系统由包含高清显示器的远程控制台、手术设备台车、容纳蛇形机械臂的手术执行系统和可弯蛇形机械臂4个部分组成。所有术式均采用经腹膜外入路。根治性前列腺切除术,患者取平卧位,脐下做约3 cm纵行切口,切开腹直肌前鞘,分离腹膜外间隙,置入操作鞘,于右麦氏点与脐之间放置12 mm套管作为辅助孔。肾部分切除术和肾上腺肿物切除术,患者取侧卧位,腋中线髂嵴上2 cm做约3 cm切口为主操作孔,切开皮肤、皮下组织、肌肉至腹膜后腔,于腋前线髂前上棘水平处放置12 mm套管作为辅助孔。连接各机械臂后操作,操作结束后,经辅助孔放置�Objective To investigate the safety and efficacy of the novel single-port surgical robotic surgical system in extraperitoneal urological surgery.Methods From February to April 2022,patients was prospectively enrolled who required laparoscopic radical prostatectomy,partial nephrectomy and adrenal tumor resection in urology department.Inclusion criteria were:age≥18 years old;BMI 18.5-30 kg/m^(2);American Society of Anesthesiologists(ASA)physical status classification system grades 1 to 3;can cooperate with the completion of the visits and related examinations stipulated in the plan,and participate voluntarily clinical trials,and consent or the guardian agrees to sign the informed consent form;tumor indicators meet one of the following surgical treatment indications:kidney tumor T1 stage,single,maximum tumor diameter≤4 cm;prostate cancer,stage≤T2b,preoperative PSA≤20 ng/ml;Gleason score≤7;adrenal tumor diameter≤7 cm,for non-functioning adrenal adenoma,tumor diameter≥3 cm.Exclusion criteria were:patients with other malignancies or a history of other malignancies and the investigators believe that they are not suitable for inclusion in this researcher;patients who have received the same type of urological surgery in the past and are not suitable for participating in this study as assessed by the investigators;included Those who have undergone other major surgery within the first 3 months and during the trial period,or who cannot recover from the side effects of any such surgery;syphilis,hepatitis B,HIV infection and carriers;long-term use of anticoagulants or blood system diseases;Unable to use effective contraception during the trial period and other conditions that the investigators deem inappropriate to participate in this trial.All operations were performed by a novel single-port robotic surgical operating system,and all surgical procedures were performed through an extraperitoneal approach.Surgical method:the surgical system is mainly composed of a remote console including a high-definition display,

关 键 词：机器人手术 单孔腹腔镜 前列腺癌 肾肿瘤 肾上腺肿瘤 

分 类 号：R699[医药卫生—泌尿科学]