国产SR-ENS-600单孔腹腔镜手术机器人系统应用于妇科良性疾病治疗的安全性和有效性初探——一项单臂研究
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国家重点研发计划(2023YFC2413404),中央高水平医院临床科研专项提升项目(2022-PUMCH-B-086),单孔腔镜手术系统产学研合作项目(FW-HXKT202209160165).


Safety and effectiveness of domestic SR-ENS-600 single-port robotic laparoscopic system in treatment of benign gynecological diseases: a single-arm study
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Supported by National Key Research and Development Program of China (2023YFC2413404), National High-Level Hospital Clinical Research Fund (2022-PUMCH-B-086), and Industry-University-Research Collaboration Project for Single-Port Laparoscopic Surgery System (FW-HXKT202209160165).

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    摘要:

    目的 初步评估国产SR-ENS-600单孔腹腔镜手术机器人系统治疗妇科良性疾病的安全性及有效性。方法 本研究为单臂试验,选取2023年1月至2025年4月于北京协和医院妇产科接受手术的患者28例,应用国产SR-ENS-600单孔腹腔镜手术机器人系统对患者实施手术。其中14例患者接受单孔机器人卵巢囊肿剔除/附件切除术(SRC组),2例接受单孔机器人子宫肌瘤剔除术(SRM组),12例接受单孔机器人全子宫切除术(SRH组)。记录手术成功率、手术时间、出血量、肛门排气时间、术后住院时间、并发症及不良事件等。结果 手术成功率为100.0%,无中转开腹或多孔腹腔镜手术。SRC组的手术时间为(90.50±34.20)min,SRM组2例患者分别为65.00 min和152.00 min,SRH组为(165.33±40.22)min,全组为(123.86±52.17)min。SRC组的出血量为5.00(5.00,6.25)mL,SRM组2例患者分别为5.00 mL和50.00 mL,SRH组为20.00(10.00,50.00)mL,全组为10.00(5.00,27.50)mL。SRC组的肛门排气时间为(16.71±6.47)h,SRM组2例患者分别为17.00 h和20.00 h,SRH组为(25.21±7.46)h,全3组为(20.48±7.79)h。SRC组的术后住院时间为2.00(2.00,3.00)d,SRM组2例患者均为2.00 d,SRH组为5.00(2.25,5.75)d,全组为3.00(2.00,3.75)d 。无一例患者发生术中或术后并发症,或再入院手术;无严重不良事件发生。结论 初步研究结果显示国产SR-ENS-600单孔腹腔镜手术机器人系统治疗妇科良性疾病安全、有效,出血量少、住院时间短。

    Abstract:

    Objective To evaluate the safety and effectiveness of the domestic SR-ENS-600 single-port robotic laparoscopic system for benign gynecological diseases. Methods This study was conducted as a single-arm design. A total of 28 patients who underwent surgery at the Department of Obstetrics and Gynecology of Peking Union Medical College Hospital between Jan. 2023 and Apr. 2025 were enrolled. The procedures were performed using the domestic SR-ENS-600 single-port robotic laparoscopic system. Among them, 14 patients underwent single-port robotic ovarian cystectomy/adnexectomy (SRC group), 2 underwent single-port robotic myomectomy (SRM group), and 12 underwent single-port robotic total hysterectomy (SRH group). The surgical success rate, operative time, blood loss, time to return of bowel activity, postoperative hospital stay, complications, and adverse events were recorded. Results The surgical success rate was 100.0%, with no conversions to laparotomy or multi-port laparoscopic surgery. The operative time was (90.50±34.20) min in the SRC group, 65.00 min and 152.00 min for the 2 cases in the SRM group, (165.33±40.22) min in the SRH group, and (123.86±52.17) min for all the patients. The blood loss was 5.00 (5.00, 6.25) mL in the SRC group, 5.00 mL and 50.00 mL for the 2 cases in the SRM group, 20.00 (10.00, 50.00) mL in the SRH group, and 10.00 (5.00, 27.50) mL for all the patients. The time to return of bowel activity was (16.71±6.47) h in the SRC group, 17.00 h and 20.00 h for the 2 cases in the SRM group, (25.21±7.46) h in the SRH group, and (20.48±7.79) h for all patients. The postoperative hospital stay was 2.00 (2.00, 3.00) d in the SRC group, 2.00 d for both cases in the SRM group, 5.00 (2.25, 5.75) d in the SRH group, and 3.00 (2.00, 3.75) d for all the patients. No intraoperative or postoperative complications, reoperations, or serious adverse events occurred in any patients. Conclusion Preliminary results indicate that the domestic SR-ENS-600 single-port robotic laparoscopic system is safe and effective for the treatment of benign gynecological diseases, with less blood loss and shorter postoperative hospital stay.

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  • 收稿日期:2025-07-07
  • 最后修改日期:2025-10-07
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  • 在线发布日期: 2025-11-25
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