Cheng Shen, Weigang Yan, Silu Chen, Weifeng Xu, Xiang Wang, Jie Dong, Zhongyuan Zhang, Kunlin Yang, Shubo Fan, Zhihua Li, Xu Chen, Meng Zhang, Zaoheng Jin, Yisen Meng, Lin Cai, Kai Zhang, Zheng Zhang, Li Mu, Zhigang Ji, Liqun Zhou, Xuesong Li
{"title":"康多手术系统与达芬奇Si系统的机器人辅助根治性前列腺切除术：一项前瞻性双中心随机对照试验。","authors":"Cheng Shen, Weigang Yan, Silu Chen, Weifeng Xu, Xiang Wang, Jie Dong, Zhongyuan Zhang, Kunlin Yang, Shubo Fan, Zhihua Li, Xu Chen, Meng Zhang, Zaoheng Jin, Yisen Meng, Lin Cai, Kai Zhang, Zheng Zhang, Li Mu, Zhigang Ji, Liqun Zhou, Xuesong Li","doi":"10.1016/j.euf.2024.05.023","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The KangDuo Surgical Robot (KD-SR) is a newly developed surgical robot.</p><p><strong>Objective: </strong>To compare the safety and efficacy of robot-assisted radical prostatectomy (RARP) using the KD-SR with those of the da Vinci Si Surgical System (DV-SS-Si).</p><p><strong>Design, setting, and participants: </strong>A prospective double-center noninferiority randomized controlled trial was conducted among 18-75-yr-old patients with suspected T1-2N0M0 prostate cancer (PCa) scheduled for RARP.</p><p><strong>Intervention: </strong>RARP with the KD-SR (KD-RARP) versus RARP with the DV-SS-Si (DV-RARP).</p><p><strong>Outcome measurements and statistical analysis: </strong>The primary outcome was surgical success, defined as follows: surgery can be performed according to the established protocol, without switching to other surgical modalities, and without secondary surgery due to surgical complications after surgery. The secondary outcome was short-term functional and oncological outcomes. The noninferiority threshold was set at 10%.</p><p><strong>Results and limitations: </strong>Eighty patients were enrolled, while the full analysis set finally included 79 patients (40 with KD-RARP and 39 with DV-RARP). The success rate was 100% in both groups. We could not find differences in urinary continence rate at 1, 2, 3, and 4 wk after catheter removal between the groups (p > 0.05). The rate of Clavien-Dindo grade II adverse events was 20% in the KD-RARP group and 17.9% in the DV-RARP group (p = 0.82), and no grade ≥III adverse events occurred. The median operation time was significantly longer in the KD-RARP group than in the DV-RARP group (177.5 vs 145 min, p = 0.012). The main limitations were the short follow-up period and that survival was not considered as the primary outcome.</p><p><strong>Conclusions: </strong>The KD-SR is a viable option for RARP, with acceptable short-term outcomes compared with the DV-SS-Si for T1-2 PCa.</p><p><strong>Patient summary: </strong>This is the first prospective randomized controlled trial to compare the KangDuo Surgical Robot (KD-SR) versus the da Vinci Si Surgical System (DV-SS-Si) for robot-assisted radical prostatectomy, which determines that the KD-SR is noninferior to the DV-SS-Si regarding safety and efficacy for T1-T2 prostate cancer.</p>","PeriodicalId":4,"journal":{"name":"ACS Applied Energy Materials","volume":null,"pages":null},"PeriodicalIF":5.4000,"publicationDate":"2024-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Robot-assisted Radical Prostatectomy with the KangDuo Surgical System Versus the da Vinci Si System: A Prospective, Double-center, Randomized Controlled Trial.\",\"authors\":\"Cheng Shen, Weigang Yan, Silu Chen, Weifeng Xu, Xiang Wang, Jie Dong, Zhongyuan Zhang, Kunlin Yang, Shubo Fan, Zhihua Li, Xu Chen, Meng Zhang, Zaoheng Jin, Yisen Meng, Lin Cai, Kai Zhang, Zheng Zhang, Li Mu, Zhigang Ji, Liqun Zhou, Xuesong Li\",\"doi\":\"10.1016/j.euf.2024.05.023\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The KangDuo Surgical Robot (KD-SR) is a newly developed surgical robot.</p><p><strong>Objective: </strong>To compare the safety and efficacy of robot-assisted radical prostatectomy (RARP) using the KD-SR with those of the da Vinci Si Surgical System (DV-SS-Si).</p><p><strong>Design, setting, and participants: </strong>A prospective double-center noninferiority randomized controlled trial was conducted among 18-75-yr-old patients with suspected T1-2N0M0 prostate cancer (PCa) scheduled for RARP.</p><p><strong>Intervention: </strong>RARP with the KD-SR (KD-RARP) versus RARP with the DV-SS-Si (DV-RARP).</p><p><strong>Outcome measurements and statistical analysis: </strong>The primary outcome was surgical success, defined as follows: surgery can be performed according to the established protocol, without switching to other surgical modalities, and without secondary surgery due to surgical complications after surgery. The secondary outcome was short-term functional and oncological outcomes. The noninferiority threshold was set at 10%.</p><p><strong>Results and limitations: </strong>Eighty patients were enrolled, while the full analysis set finally included 79 patients (40 with KD-RARP and 39 with DV-RARP). The success rate was 100% in both groups. We could not find differences in urinary continence rate at 1, 2, 3, and 4 wk after catheter removal between the groups (p > 0.05). The rate of Clavien-Dindo grade II adverse events was 20% in the KD-RARP group and 17.9% in the DV-RARP group (p = 0.82), and no grade ≥III adverse events occurred. The median operation time was significantly longer in the KD-RARP group than in the DV-RARP group (177.5 vs 145 min, p = 0.012). The main limitations were the short follow-up period and that survival was not considered as the primary outcome.</p><p><strong>Conclusions: </strong>The KD-SR is a viable option for RARP, with acceptable short-term outcomes compared with the DV-SS-Si for T1-2 PCa.</p><p><strong>Patient summary: </strong>This is the first prospective randomized controlled trial to compare the KangDuo Surgical Robot (KD-SR) versus the da Vinci Si Surgical System (DV-SS-Si) for robot-assisted radical prostatectomy, which determines that the KD-SR is noninferior to the DV-SS-Si regarding safety and efficacy for T1-T2 prostate cancer.</p>\",\"PeriodicalId\":4,\"journal\":{\"name\":\"ACS Applied Energy Materials\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":5.4000,\"publicationDate\":\"2024-06-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"ACS Applied Energy Materials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.euf.2024.05.023\",\"RegionNum\":3,\"RegionCategory\":\"材料科学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CHEMISTRY, PHYSICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"ACS Applied Energy Materials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.euf.2024.05.023","RegionNum":3,"RegionCategory":"材料科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CHEMISTRY, PHYSICAL","Score":null,"Total":0}
Robot-assisted Radical Prostatectomy with the KangDuo Surgical System Versus the da Vinci Si System: A Prospective, Double-center, Randomized Controlled Trial.
Background: The KangDuo Surgical Robot (KD-SR) is a newly developed surgical robot.
Objective: To compare the safety and efficacy of robot-assisted radical prostatectomy (RARP) using the KD-SR with those of the da Vinci Si Surgical System (DV-SS-Si).
Design, setting, and participants: A prospective double-center noninferiority randomized controlled trial was conducted among 18-75-yr-old patients with suspected T1-2N0M0 prostate cancer (PCa) scheduled for RARP.
Intervention: RARP with the KD-SR (KD-RARP) versus RARP with the DV-SS-Si (DV-RARP).
Outcome measurements and statistical analysis: The primary outcome was surgical success, defined as follows: surgery can be performed according to the established protocol, without switching to other surgical modalities, and without secondary surgery due to surgical complications after surgery. The secondary outcome was short-term functional and oncological outcomes. The noninferiority threshold was set at 10%.
Results and limitations: Eighty patients were enrolled, while the full analysis set finally included 79 patients (40 with KD-RARP and 39 with DV-RARP). The success rate was 100% in both groups. We could not find differences in urinary continence rate at 1, 2, 3, and 4 wk after catheter removal between the groups (p > 0.05). The rate of Clavien-Dindo grade II adverse events was 20% in the KD-RARP group and 17.9% in the DV-RARP group (p = 0.82), and no grade ≥III adverse events occurred. The median operation time was significantly longer in the KD-RARP group than in the DV-RARP group (177.5 vs 145 min, p = 0.012). The main limitations were the short follow-up period and that survival was not considered as the primary outcome.
Conclusions: The KD-SR is a viable option for RARP, with acceptable short-term outcomes compared with the DV-SS-Si for T1-2 PCa.
Patient summary: This is the first prospective randomized controlled trial to compare the KangDuo Surgical Robot (KD-SR) versus the da Vinci Si Surgical System (DV-SS-Si) for robot-assisted radical prostatectomy, which determines that the KD-SR is noninferior to the DV-SS-Si regarding safety and efficacy for T1-T2 prostate cancer.
期刊介绍：
ACS Applied Energy Materials is an interdisciplinary journal publishing original research covering all aspects of materials, engineering, chemistry, physics and biology relevant to energy conversion and storage. The journal is devoted to reports of new and original experimental and theoretical research of an applied nature that integrate knowledge in the areas of materials, engineering, physics, bioscience, and chemistry into important energy applications.
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