Gulz Marietta, Bodet Marie-Lucile, Streich Matthias, Habegger Anna, Heubner Martin, Erhardt Damaris, Bogdanovic Borjana, Mueller Michael David
Department of Obstetrics and Gynecology, Bern University Hospital, 3010, Bern, Switzerland.
Department of Gynecology, Groupe Hospitalier Saintes - Saint-Jean-D'Angély, Saintes, France.
J Robot Surg. 2025 Sep 26;19(1):634. doi: 10.1007/s11701-025-02647-0.
Minimally invasive hysterectomy is the preferred surgical approach for benign gynecologic conditions. The DEXTER® Robotic Surgery System was developed to address the limitations of conventional robotic systems, offering a mobile, modular, and accessible alternative adaptable to various surgical environments. This prospective, multicenter, single-arm study evaluated the clinical performance and early postoperative safety of the robotic-assisted hysterectomy with adnexal surgery for benign indications with DEXTER. The primary endpoints were short-term safety, assessed by the occurrence of Clavien-Dindo grade ≥ III adverse events up to 42 days postoperatively, and procedural success without conversion to laparoscopy or open surgery. Fifty-two patients were enrolled across four European centers-one university hospital and three community hospitals. All procedures were successfully completed without intraoperative complications or conversions. The mean total skin-to-skin operative time was 121.9 ± 42.7 min, and the mean estimated blood loss was 87.8 ± 93.8 mL. The system also demonstrated efficient setup with a mean docking time of 3.8 ± 1.3 min, as well as the feasibility of a three-trocar technique for minimal scarring and potential for outpatient application in select cases. The mean time to discharge was 2.0 ± 0.9 days. One major Clavien-Dindo IIIb complication occurred. No device-related adverse events were reported. These results confirm the safety and performance of DEXTER in robotic-assisted hysterectomy and support its role in expanding access to robotic-assisted surgery in diverse clinical settings.Trial registration: ClinicalTrials.gov NCT06473675.
微创子宫切除术是治疗良性妇科疾病的首选手术方法。DEXTER®机器人手术系统的开发旨在解决传统机器人系统的局限性，提供一种可移动、模块化且易于使用的替代方案，适用于各种手术环境。这项前瞻性、多中心、单臂研究评估了使用DEXTER进行机器人辅助子宫切除术加附件手术治疗良性疾病的临床性能和术后早期安全性。主要终点是短期安全性，通过术后42天内发生Clavien-Dindo≥III级不良事件来评估，以及手术成功且无需转为腹腔镜手术或开放手术。四个欧洲中心（一家大学医院和三家社区医院）共纳入了52例患者。所有手术均成功完成，无术中并发症或转为其他手术。平均总皮肤到皮肤手术时间为121.9±42.7分钟，平均估计失血量为87.8±93.8毫升。该系统还展示了高效的设置，平均对接时间为3.8±1.3分钟，以及三套管技术用于最小化疤痕的可行性和在特定病例中门诊应用的潜力。平均出院时间为2.0±0.9天。发生了1例主要的Clavien-Dindo IIIb级并发症。未报告与设备相关的不良事件。这些结果证实了DEXTER在机器人辅助子宫切除术中的安全性和性能，并支持其在不同临床环境中扩大机器人辅助手术可及性方面的作用。试验注册：ClinicalTrials.gov NCT06473675
