Early evaluation of a next‐generation surgical system in robot‐assisted total laparoscopic hysterectomy: A prospective clinical cohort study

Abstract

Introduction This study aimed to demonstrate the safe and effective use of the Versius surgical system (CMR Surgical, Cambridge, UK) in robot‐assisted total laparoscopic hysterectomy. This surgical robot was developed iteratively with input from surgeons to improve surgical outcomes and end‐user experience. We report data from the gynecology cohort of an early clinical trial designed in broad alignment with IDEAL‐D (Idea, Development, Exploration, Assessment, Long‐term follow‐up – Devices) stage 2b (Exploration). Material and methods The study is registered in the Indian clinical trials register (CTRI/2019/02/017872). Adult women requiring total hysterectomy who provided informed consent and met the eligibility criteria underwent procedures at one of three hospitals in India. Five surgeons performed robot‐assisted total laparoscopic hysterectomies using the device from March 2019 to September 2020. The primary endpoint was rate of unplanned conversion to conventional laparoscopic or open surgery. Adverse events were adjudicated by an independent clinical events committee using endoscope video recordings and clinical notes. Results In total, 144 women underwent surgery (median age: 44 years [range: 28–78]; median body mass index 25.8 kg/m2 [range: 14.3–47.8]). The rate of unplanned conversion to conventional laparoscopy was 2/144 (1.4%); neither conversion was device related. No surgery was converted to open. In total, 13 adverse events occurred among seven (4.9%) patients, comprising seven serious adverse events and six adverse events. One serious adverse event was deemed device‐related. Two patients were readmitted to hospital within 30 days; both made a full recovery. No patients died within 90 days of surgery. Conclusions The device provides a safe and effective option for total laparoscopic hysterectomy; these findings support its continued implementation in larger patient cohorts and expansion in other major minimal access indications.

Safe implementation of surgical innovation: a prospective registry of the Versius Robotic Surgical System

“…12 After rigorous preclinical testing with successful completion of a range of gynecological, urological, renal and general surgical procedures in both cadavers and live porcine studies, [13][14][15][16] the device has been successfully and safely used clinically in live-human gynecological, general and colorectal surgical procedures. [17][18][19][20][21] The Versius Surgical Registry is a prospective, multicenter, international, observational registry with ongoing cumulative enrollment across surgical specialties. The aim of the registry is to demonstrate that the device can be safely implemented through prospective cohort studies embedded within a prospective clinical registry.…”

“…Previous studies have validated the usability of the device by trained intended users 12. After rigorous preclinical testing with successful completion of a range of gynecological, urological, renal and general surgical procedures in both cadavers and live porcine studies,13–16 the device has been successfully and safely used clinically in live-human gynecological, general and colorectal surgical procedures 17–21…”

Preclinical evaluation of the Versius surgical system: A next‐generation surgical robot for use in minimal access prostate surgery

“…Preclinical studies have provided proof of concept for the use of the device in a range of procedures for gynaecology, renal and urology, and general and colorectal surgery (Stage 1) 21–24 . These studies have supported continuation to in‐human clinical trials of the surgical robot in hysterectomy and cholecystectomy surgeries, 25,26 and implementation in other surgical specialties is ongoing (Stage 2).…”

Medicaroid robotic assisted surgery system: A feasibility study

“…The usability of both systems has been recently evaluated in both the preclinical 6,7 and the clinical setting. 8 –11…”

“…The usability of both systems has been recently evaluated in both the preclinical 6,7 and the clinical setting. [8][9][10][11] The hinotori™ robotic system is a novel surgical robot developed by Medicaroid (Medicaroid Corporation, Kobe, Japan). The hinotori™ consists of a full high-vision 3D console and a patient-side cart with four eight-axis robotic arms (Figure 1), 12 designed to reduce the arm-to-arm or the arm-to-assistant interference for smoother movements.…”