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<p>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&#xa0;≥&#xa0;III adverse events up to 42&#xa0;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&#xa0;min, and the mean estimated blood loss was 87.8 ± 93.8&#xa0;mL. The system also demonstrated efficient setup with a mean docking time of 3.8 ± 1.3&#xa0;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&#xa0;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.</p><p><i>Trial registration</i>: ClinicalTrials.gov NCT06473675.</p>

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Multicenter evaluation of the DEXTER® Robotic Surgery System for Total Hysterectomy with Adnexal Surgery

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年9月26日

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  • Marietta Gulz,
  • Marie-Lucile Bodet,
  • Matthias Streich,
  • Anna Habegger,
  • Martin Heubner,
  • Damaris Erhardt,
  • Borjana Bogdanovic,
  • Michael David Mueller

摘要

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.