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

Abstract

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.