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.

Keywords: clinical trial; gynecology; minimal access surgery; robot-assisted surgery; robotic surgical system; surgical robot.

FIGURE 1

Overview of the device, port positioning, and operating room layout. Schematic representation of the setup of the device (A) and real‐world image of the device setup (B); adapted from Haig et al. Common port positioning (C) with corresponding BSU positions (D); adapted from Kelkar et al. The assistant port was for nonrobotic laparoscopic instruments. Umbilicus is where the ML crosses the SUL. Aux: auxiliary monitor; BSU: bedside unit; Console: surgeon console; Endo: endoscope; Instr: instrument; MCL: mid‐clavicular line; ML: midline; SUL: supine‐umbilical line

FIGURE 2

Study CONSORT diagram. ^aOne patient did not return to the site for screening. ^bBased on routine endoscopic examination, surgeons decided that alternative more familiar approaches (three conventional laparoscopic hysterectomies and one open surgery) were more appropriate for four women who had highly complex anatomies and/or disease states, such as an enlarged uterus and fundal fibroid, and multiple extensive adhesions involving the uterus, sigmoid colon, rectum, ovaries, and ureter. ^cOne patient underwent total hysterectomy and cholecystectomy in the same surgery, both of which were successfully completed using the device without complications or adverse events. ^dIncludes two patients who also underwent bilateral salpingo‐oophorectomies. ^eOne patient had a urinary bladder injury at the time of anterior colpotomy, which was sutured with conventional laparoscopy by a urologist. SAE, serious adverse event

FIGURE 3

Operative time, intra‐operative blood loss, and length of hospital stay. Operative time from first incision to skin closure (A), estimated intra‐operative blood loss (B), length of hospital stay from day procedure performed to patient discharge from hospital (C). For A and C, middle vertical lines represent the medians, left and right box edges represent the first and third quartiles, and lower and upper whiskers extend to the respective lowest and highest values. ^aIncludes patients with estimated blood loss recorded as <100 ml. ^bIncludes patients with estimated blood loss recorded as <500 ml