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

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.

Interim safety analysis of the first-in-human clinical trial of the Versius surgical system, a new robot-assisted device for use in minimal access surgery.

OBJECTIVE: The aim of this study was to provide an interim safety analysis of the first 30 surgical procedures performed using the Versius Surgical System. BACKGROUND: Robot-assisted laparoscopy has been developed to overcome some of the important limitations of conventional laparoscopy. The new system is currently undergoing a first-in-human prospective clinical trial to confirm the safety and effectiveness of the device when performing minimal access surgery (MAS). METHODS: Procedures were performed using Versius by a lead surgeon supported by an operating room (OR) team. Male or female patients aged between 18 and 65 years old and requiring elective minor or intermediate gynaecological or general surgical procedures were enrolled. The primary endpoint was the rate of unplanned conversion of procedures to other MAS or open surgery. RESULTS: The procedures included nine cholecystectomies, six robot-assisted total laparoscopic hysterectomies, four appendectomies, five diagnostic laparoscopy cases, two oophorectomies, two fallopian tube recanalisation procedures, an ovarian cystectomy and a salpingo-oophorectomy procedure. All procedures were completed successfully without the need for conversion to MAS or open surgery. No patient returned to the OR within 24 h of surgery and readmittance rate at 30 and 90 days post-surgery was 1/30 (3.3%) and 2/30 (6.7%), respectively. CONCLUSIONS: This first-in-human interim safety analysis demonstrates that the Versius Surgical System is safe and can be used to successfully perform minor or intermediate gynaecological and general surgery procedures. The cases presented here provide evidence that the Versius clinical trial can continue to extend recruitment and begin to include major procedures, in alignment with the IDEAL-D Framework Stage 2b: Exploration.

Pectineal Ligament Hysteropexy for Uterine Prolapse in Premenopausal Women by Open and Laparoscopic Approach in Indian Urban and Rural Centers.

OBJECTIVE: The aim of this study was to evaluate (a) the surgical outcomes of pectineal ligament hysteropexy (PLH) for uterine prolapse by laparotomy and (b) the feasibility and safety of the procedure by laparoscopic route. METHODS: This is a retrospective consecutive case series of women who underwent PLH from January 1998 to December 2011. The prolapsed uterus was suspended with polyester tape to pectineal ligament on either side through a Cherney incision or laparoscopically at 3 urban and 3 rural hospitals in India. RESULTS: In 194 women who underwent PLH (176 open and 18 laparoscopic), there were no intraoperative complications. The mean follow-up was 6.5 years (range, 0.5-12 years) for open method and 1 year (range, 0.5-2 years) for laparoscopic approach. There were 46 births in 40 women after the procedure including 32 vaginal and 14 cesarean deliveries. Overall, 10 women (5.1%) had uterine prolapse recurrence; 7 of these occurred after vaginal delivery. One woman had tape erosion into the bladder because of pelvic tuberculosis. At follow-up, 12 women developed cystocele, and 7 women developed portio vaginalis elongation. There were no postoperative enteroceles. Overall reoperation rate was 14.9%. Laparoscopic PLH had minimal morbidity with no recurrence over 2 years. CONCLUSIONS: Open PLH for uterine prolapse may be safely performed and gives durable support to the prolapsed uterus with low recurrence risk.

Pectineal ligament suspension of prolapsed vaginal vault.

OBJECTIVE: To report on a collective pectineal ligament suspension experience acquired over 12 years in India with 119 women who presented with prolapsed vaginal vault. The feasibility and effectiveness of the procedure was assessed for the open and laparoscopic routes. METHODS: The prolapsed vaginal vault was suspended unilaterally to the pectineal ligament using polyester tape at 3 urban and 3 rural hospitals. The procedure was done through a Cherney incision in 104 women. In the remaining 15 women, it was done laparoscopically at a single urban center. RESULTS: There were no intraoperative complications. The mean follow-up was 5.5 years (range, 0.5-12 years). Only 2 women had vaginal prolapse recurrence, at 3 and 5 years. Two had asymptomatic tape erosion, at 2 and 5 years, and a mild cystocele appeared in 5 women and a low rectocele in 4. However, none of these women required further vaginal surgery during their follow-up period. CONCLUSION: The present study demonstrates the long-term safety and effectiveness of pectineal ligament suspension for vaginal vault prolapse by the open and the laparoscopic routes. As it was done by surgeons of varying experience at centers with varying resources, the procedure can be readily mastered by any gynecologic surgeon.