医学
肾切除术
随机对照试验
系统
失血
机械人手术
腹腔镜手术
腹腔镜检查
外科
肾
内分泌学
作者
Yu Gao,Yang Yang,Shaoxi Niu,Wang He,Jin Tao,Shengjie Guo,Hongzhao Li,Xin Ma,Jian Huang,Xing Ai,Fangjian Zhou,Xuepei Zhang,Xu Zhang
标识
DOI:10.1097/js9.0000000000001166
摘要
Purpose: This study aimed to compare the safety and effectiveness of the MP1000 surgical system with the da Vinci ® Si robot system in robot-assisted partial nephrectomy (RAPN) through a prospective, single-blinded, randomized control trial. Materials and Methods: A total of 62 patients who were scheduled to undergo RAPN were randomly assigned to either the da Vinci® Si robot or MP1000 group. A noninferiority test was conducted with a non-inferior intermediate value of 10%. The study compared installation and operation times, estimated blood loss, warm ischemia time, postoperative surgical margin, rate of conversion to open surgery, eGFR level, complications, and other safety indicators between the two groups. Results: All procedures were successfully completed without the need for conversion to open or laparoscopic surgery, and no major complications were observed during the process. The test of noninferiority was achieved. There were no significant differences in median installation time, operation time, complication rate at 3 months, rate of positive surgical margin, and eGFR level at 3 months between the groups. Additionally, no evidence of recurrence was found on imaging in both groups. No difference in National Aeronautics and Space Administration task load index results for ergonomic considerations. A limitation of this study was its small sample size. Conclusions: The MP1000 system is a suitable platform for RAPN with safety and effectiveness comparable with da Vinci ® Si system.
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