{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T20:55:09Z","timestamp":1790628909374,"version":"4.1.0"},"reference-count":32,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2023,2,27]],"date-time":"2023-02-27T00:00:00Z","timestamp":1677456000000},"content-version":"unspecified","delay-in-days":26,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"CMR Surgical","award":["Not applicable"],"award-info":[{"award-number":["Not applicable"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Surg Interv Health Technologies"],"accepted":{"date-parts":[[2023,2,5]]},"published-print":{"date-parts":[[2023,2]]},"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>To describe a new, international, prospective surgical registry developed to accompany the clinical implementation of the Versius Robotic Surgical System by accumulating real-world evidence of its safety and effectiveness.<\/jats:p><\/jats:sec><jats:sec><jats:title>Interventions<\/jats:title><jats:p>This robotic surgical system was introduced in 2019 for its first live-human case. With its introduction, cumulative database enrollment was initiated across several surgical specialties, with systematic data collection via a secure online platform.<\/jats:p><\/jats:sec><jats:sec><jats:title>Main outcome measures<\/jats:title><jats:p>Pre-operative data include diagnosis, planned procedure(s), characteristics (age, sex, body mass index and disease status) and surgical history. Peri-operative data include operative time, intra-operative blood loss and use of blood transfusion products, intra-operative complications, conversion to an alternative technique, return to the operating room prior to discharge and length of hospital stay. Complications and mortality within 90 days of surgery are also recorded.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The data collected in the registry are analyzed as comparative performance metrics, by meta-analyses or by individual surgeon performance using control method analysis. Continual monitoring of key performance indicators, using various types of analyses and outputs within the registry, have provided meaningful insights that help institutions, teams and individual surgeons to perform most effectively and ensure optimal patient safety.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Harnessing the power of large-scale, real-world registry data for routine surveillance of device performance in live-human surgery from first use will enhance the safety and efficacy outcomes of innovative surgical techniques. Data are crucial to driving the evolution of robot-assisted minimal access surgery while minimizing risk to patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration number<\/jats:title><jats:p>CTRI\/2019\/02\/017872.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjsit-2022-000144","type":"journal-article","created":{"date-parts":[[2023,2,27]],"date-time":"2023-02-27T14:00:55Z","timestamp":1677506455000},"page":"e000144","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":8,"title":["Safe implementation of surgical innovation: a prospective registry of the Versius Robotic Surgical System"],"prefix":"10.1136","volume":"5","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0285-0976","authenticated-orcid":false,"given":"Ilias","family":"Soumpasis","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samer","family":"Nashef","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel","family":"Dunning","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Moran","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2176-8118","authenticated-orcid":false,"given":"Mark","family":"Slack","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2023,2,27]]},"reference":[{"key":"2024051514370854000_5.1.e000144.1","doi-asserted-by":"crossref","DOI":"10.1136\/bmjsit-2019-000003","article-title":"Determining value of coordinated registry networks (crns): a case of transcatheter valve therapies","volume":"1","author":"Pappas","year":"2019","journal-title":"BMJ Surg Interv Health Technol"},{"key":"2024051514370854000_5.1.e000144.2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(10)61116-6"},{"key":"2024051514370854000_5.1.e000144.3","doi-asserted-by":"publisher","DOI":"10.1097\/SLA.0b013e31829ccc5f"},{"key":"2024051514370854000_5.1.e000144.4","doi-asserted-by":"crossref","first-page":"595","DOI":"10.1056\/NEJMp1712001","article-title":"Medical devices in the real world","volume":"378","author":"Resnic","year":"2018","journal-title":"N Engl J Med"},{"key":"2024051514370854000_5.1.e000144.5","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(09)61116-8"},{"key":"2024051514370854000_5.1.e000144.6","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.i2372","article-title":"IDEAL-D: a rational framework for evaluating and regulating the use of medical devices","volume":"353","author":"Sedrakyan","year":"2016","journal-title":"BMJ"},{"key":"2024051514370854000_5.1.e000144.7","doi-asserted-by":"crossref","DOI":"10.1136\/bmjsit-2019-000019","article-title":"Using end-user feedback to optimize the design of the versius surgical system, a new robot-assisted device for use in minimal access surgery","volume":"1","author":"Hares","year":"2019","journal-title":"BMJ Surg Interv Health Technol"},{"key":"2024051514370854000_5.1.e000144.8","doi-asserted-by":"crossref","first-page":"1347","DOI":"10.1007\/s11701-021-01358-6","article-title":"The burden of performing minimal access surgery: Ergonomics survey results from 462 surgeons across Germany, the UK and the USA","volume":"16","author":"Morton","year":"2022","journal-title":"J Robot Surg"},{"key":"2024051514370854000_5.1.e000144.9","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.amsu.2017.12.013","article-title":"Surgeon symptoms, strain, and selections: systematic review and meta-analysis of surgical Ergonomics","volume":"27","author":"Stucky","year":"2018","journal-title":"Ann Med Surg (Lond)"},{"key":"2024051514370854000_5.1.e000144.10","doi-asserted-by":"crossref","first-page":"525","DOI":"10.1007\/s11701-019-01024-y","article-title":"Transition effects from laparocscopic to robotic surgery skills in small cavities","volume":"14","author":"Moncayo","year":"2020","journal-title":"J Robot Surg"},{"key":"2024051514370854000_5.1.e000144.11","doi-asserted-by":"crossref","first-page":"2359","DOI":"10.1007\/s00345-019-03037-6","article-title":"Artificial intelligence and robotics: a combination that is changing the operating room","volume":"38","author":"Andras","year":"2020","journal-title":"World J Urol"},{"key":"2024051514370854000_5.1.e000144.12","doi-asserted-by":"crossref","DOI":"10.1136\/bmjsit-2019-000028","article-title":"Usability assessment of versius, a new robot-assisted surgical device for use in minimal access surgery","volume":"2","author":"Haig","year":"2020","journal-title":"BMJ Surg Interv Health Technol"},{"key":"2024051514370854000_5.1.e000144.13","doi-asserted-by":"crossref","unstructured":"Carey M , Bali A , Pandeva I , et al . Preclinical evaluation of a new robot-assisted surgical system for use in gynecology minimal access surgery. Gynecol Surg 2020;17. doi:10.1186\/s10397-020-01069-0","DOI":"10.1186\/s10397-020-01069-0"},{"key":"2024051514370854000_5.1.e000144.14","doi-asserted-by":"crossref","first-page":"2169","DOI":"10.1007\/s00464-020-07622-4","article-title":"Preclinical evaluation of the versius surgical system, a new robot-assisted surgical device for use in minimal access general and colorectal procedures","volume":"35","author":"Morton","year":"2021","journal-title":"Surg Endosc"},{"key":"2024051514370854000_5.1.e000144.15","doi-asserted-by":"crossref","first-page":"444","DOI":"10.1016\/j.euf.2020.01.011","article-title":"Preclinical evaluation of the versius surgical system, a new robot-assisted surgical device for use in minimal access renal and prostate surgery","volume":"7","author":"Thomas","year":"2021","journal-title":"Eur Urol Focus"},{"key":"2024051514370854000_5.1.e000144.16","doi-asserted-by":"crossref","first-page":"471","DOI":"10.1007\/s10151-019-01992-1","article-title":"Assessment of the versius surgical robotic system for dual-field synchronous transanal total mesorectal excision (tatme) in a preclinical model: will tomorrow\u2019s surgical robots promise newfound options?","volume":"23","author":"Atallah","year":"2019","journal-title":"Tech Coloproctol"},{"key":"2024051514370854000_5.1.e000144.17","doi-asserted-by":"crossref","first-page":"978","DOI":"10.1111\/aogs.14407","article-title":"Early evaluation of a next-generation surgical system in robot-assisted total laparoscopic hysterectomy: a prospective clinical cohort study","volume":"101","author":"Borse","year":"2022","journal-title":"Acta Obstet Gynecol Scand"},{"key":"2024051514370854000_5.1.e000144.18","doi-asserted-by":"crossref","first-page":"1233","DOI":"10.1111\/codi.15568","article-title":"Implementation of the versius robotic surgical system for colorectal cancer surgery: first clinical experience","volume":"23","author":"Collins","year":"2021","journal-title":"Colorectal Dis"},{"key":"2024051514370854000_5.1.e000144.19","doi-asserted-by":"crossref","first-page":"5193","DOI":"10.1007\/s00464-020-08014-4","article-title":"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","volume":"35","author":"Kelkar","year":"2021","journal-title":"Surg Endosc"},{"key":"2024051514370854000_5.1.e000144.20","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1097\/SLA.0000000000005410","article-title":"An early prospective clinical study to evaluate the safety and performance of the versius surgical system in robot-assisted cholecystectomy","volume":"277","author":"Kelkar","year":"2022","journal-title":"Ann Surg"},{"key":"2024051514370854000_5.1.e000144.21","first-page":"451","article-title":"Feasibility of robotic radical hysterectomy (RRH) with a new robotic system","volume":"15","author":"Puntambekar","year":"2021","journal-title":"Experience at Galaxy Care Laparoscopy Institute J Robot Surg"},{"key":"2024051514370854000_5.1.e000144.22","doi-asserted-by":"crossref","DOI":"10.1136\/bmjsit-2020-000057","article-title":"Assessment of the training program for versius, a new innovative robotic system for use in minimal access surgery","volume":"3","author":"Butterworth","year":"2021","journal-title":"BMJ Surg Interv Health Technol"},{"key":"2024051514370854000_5.1.e000144.23","doi-asserted-by":"crossref","DOI":"10.1136\/bmjsit-2021-000115","article-title":"Response to: \u201c rise of the machines \u201d: human factors and training for robotic-assisted surgery","volume":"3","author":"Butterworth","year":"2021","journal-title":"BMJ Surg Interv Health Technologies"},{"key":"2024051514370854000_5.1.e000144.24","doi-asserted-by":"publisher","DOI":"10.1097\/01.sla.0000133083.54934.ae"},{"key":"2024051514370854000_5.1.e000144.25","doi-asserted-by":"publisher","DOI":"10.1016\/S0003-4975(03)00873-7"},{"key":"2024051514370854000_5.1.e000144.26","unstructured":"Montgomery DC . Introduction to statistical quality control. 7th edn. Hoboken, NJ: Wiley, 2013: 414\u201321."},{"key":"2024051514370854000_5.1.e000144.27","doi-asserted-by":"publisher","DOI":"10.1093\/intqhc\/mzq037"},{"key":"2024051514370854000_5.1.e000144.28","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(97)06507-0"},{"key":"2024051514370854000_5.1.e000144.29","doi-asserted-by":"publisher","DOI":"10.1111\/ans.15475"},{"key":"2024051514370854000_5.1.e000144.30","unstructured":"Landsberger HA . Hawthorne revisited: management and the worker, its critics, and developments in human relations in industry. Cornell University, 1958."},{"key":"2024051514370854000_5.1.e000144.31","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.m3840","article-title":"Effect of monitoring surgical outcomes using control charts to reduce major adverse events in patients: cluster randomised trial","volume":"371","author":"Duclos","year":"2020","journal-title":"BMJ"},{"key":"2024051514370854000_5.1.e000144.32","doi-asserted-by":"publisher","DOI":"10.1016\/S1010-7940(99)00134-7"}],"container-title":["BMJ Surgery, Interventions, &amp; Health Technologies"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjsit-2022-000144","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,15]],"date-time":"2024-05-15T21:55:11Z","timestamp":1715810111000},"score":1,"resource":{"primary":{"URL":"https:\/\/sit.bmj.com\/lookup\/doi\/10.1136\/bmjsit-2022-000144"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,2]]},"references-count":32,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2023,2,27]]},"published-print":{"date-parts":[[2023,2]]}},"alternative-id":["10.1136\/bmjsit-2022-000144"],"URL":"https:\/\/doi.org\/10.1136\/bmjsit-2022-000144","relation":{},"ISSN":["2631-4940"],"issn-type":[{"value":"2631-4940","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,2]]}}}