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

Content Provider	Europe PMC
Author	Borse, Mahindra Godbole, Girish Kelkar, Dhananjay Bahulikar, Madhavi Dinneen, Eoin Slack, Mark
Abstract	AbstractIntroductionThis 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 methodsThe 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.ResultsIn 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.ConclusionsThe 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.
Related Links	https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC9564672&blobtype=pdf
Page Count	9
ISSN	00016349
Journal	Acta Obstetricia et Gynecologica Scandinavica [Acta Obstet Gynecol Scand]
Volume Number	101
DOI	10.1111/aogs.14407
PubMed Central reference number	PMC9564672
Issue Number	9
PubMed reference number	35861102
e-ISSN	16000412
Language	English
Publisher	John Wiley and Sons Inc.
Publisher Date	2022-07-21
Publisher Place	Hoboken
Access Restriction	Open
Rights License	This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. © 2022 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).
Subject Keyword	clinical trial gynecology minimal access surgery robot‐assisted surgery robotic surgical system surgical robot
Content Type	Text
Resource Type	Article
Subject	Obstetrics and Gynecology