Safe implementation of surgical innovation: a prospective registry of the Versius Robotic Surgical System
Objectives 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.Interventions This robotic surgical system was introduced in 2019 f...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-06-01
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| Series: | BMJ Surgery, Interventions, & Health Technologies |
| Online Access: | https://sit.bmj.com/content/5/1/e000144.full |
| _version_ | 1797215132409921536 |
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| author | Paul Moran Samer Nashef Joel Dunning Mark Slack Ilias Soumpasis |
| author_facet | Paul Moran Samer Nashef Joel Dunning Mark Slack Ilias Soumpasis |
| author_sort | Paul Moran |
| collection | DOAJ |
| description | Objectives 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.Interventions 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.Main outcome measures 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.Results 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.Conclusions 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.Trial registration number CTRI/2019/02/017872. |
| first_indexed | 2024-03-08T16:54:32Z |
| format | Article |
| id | doaj.art-05b14413f0b7452cb5307cb02058cf1e |
| institution | Directory Open Access Journal |
| issn | 2631-4940 |
| language | English |
| last_indexed | 2024-04-24T11:25:12Z |
| publishDate | 2023-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Surgery, Interventions, & Health Technologies |
| spelling | doaj.art-05b14413f0b7452cb5307cb02058cf1e2024-04-10T18:50:31ZengBMJ Publishing GroupBMJ Surgery, Interventions, & Health Technologies2631-49402023-06-015110.1136/bmjsit-2022-000144Safe implementation of surgical innovation: a prospective registry of the Versius Robotic Surgical SystemPaul Moran0Samer Nashef1Joel Dunning2Mark Slack3Ilias Soumpasis4Department of Obstetrics and Gynaecology, Worcestershire Royal Hospital, Worcester, UKRoyal Papworth Hospital, Cambridge, UKDepartment of Cardiothoracic Surgery, James Cook University Hospital, Middlesbrough, UKCMR Surgical Ltd, Cambridge, UKCMR Surgical Ltd, Cambridge, UKObjectives 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.Interventions 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.Main outcome measures 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.Results 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.Conclusions 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.Trial registration number CTRI/2019/02/017872.https://sit.bmj.com/content/5/1/e000144.full |
| spellingShingle | Paul Moran Samer Nashef Joel Dunning Mark Slack Ilias Soumpasis Safe implementation of surgical innovation: a prospective registry of the Versius Robotic Surgical System BMJ Surgery, Interventions, & Health Technologies |
| title | Safe implementation of surgical innovation: a prospective registry of the Versius Robotic Surgical System |
| title_full | Safe implementation of surgical innovation: a prospective registry of the Versius Robotic Surgical System |
| title_fullStr | Safe implementation of surgical innovation: a prospective registry of the Versius Robotic Surgical System |
| title_full_unstemmed | Safe implementation of surgical innovation: a prospective registry of the Versius Robotic Surgical System |
| title_short | Safe implementation of surgical innovation: a prospective registry of the Versius Robotic Surgical System |
| title_sort | safe implementation of surgical innovation a prospective registry of the versius robotic surgical system |
| url | https://sit.bmj.com/content/5/1/e000144.full |
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