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Surgical endoscopy
Feb, 2024;38 (2): 554-585.

Evaluation status of current and emerging minimally invasive robotic surgical platforms.

M Boal, C Giovene Di Girasole, F Tesfai, T E M Morrison, S Higgs, J Ahmad, A Arezzo, N Francis
Author Information
  1. M Boal: The Griffin Institute, Northwick Park and St Marks Hospital, London, UK.
  2. C Giovene Di Girasole: University College London, London, UK.
  3. F Tesfai: The Griffin Institute, Northwick Park and St Marks Hospital, London, UK.
  4. T E M Morrison: Association of Laparoscopic Surgeons of Great Britain and Ireland (ALSGBI) Academy, London, UK.
  5. S Higgs: Gloucestershire Hospitals NHS Foundation Trust, Gloucester, UK.
  6. J Ahmad: University Hospitals Coventry and Warwickshire, Coventry, UK.
  7. A Arezzo: Department of Surgical Sciences, University of Turin, Turin, Italy.
  8. N Francis: The Griffin Institute, Northwick Park and St Marks Hospital, London, UK. n.francis@griffininstitute.org.uk. ORCID
PMID: 38123746 DOI: 10.1007/s00464-023-10554-4

Abstract

BACKGROUND: The rapid adoption of robotics within minimally invasive surgical specialties has also seen an explosion of new technology including multi- and single port, natural orifice transluminal endoscopic surgery (NOTES), endoluminal and "on-demand" platforms. This review aims to evaluate the validation status of current and emerging MIS robotic platforms, using the IDEAL Framework.
METHODS: A scoping review exploring robotic minimally invasive surgical devices, technology and systems in use or being developed was performed, including general surgery, gynaecology, urology and cardiothoracics. Systems operating purely outside the abdomen or thorax and endoluminal or natural orifice platforms were excluded. PubMed, Google Scholar, journal reports and information from the public domain were collected. Each company was approached via email for a virtual interview to discover more about the systems and to quality check data. The IDEAL Framework is an internationally accepted tool to evaluate novel surgical technology, consisting of four stages: idea, development/exploration, assessment, and surveillance. An IDEAL stage, synonymous with validation status in this review, was assigned by reviewing the published literature.
RESULTS: 21 companies with 23 different robotic platforms were identified for data collection, 13 with national and/or international regulatory approval. Of the 17 multiport systems, 1 is fully evaluated at stage 4, 2 are stage 3, 6 stage 2b, 2 at stage 2a, 2 stage 1, and 4 at the pre-IDEAL stage 0. Of the 6 single-port systems none have been fully evaluated with 1 at stage 3, 3 at stage 1 and 2 at stage 0.
CONCLUSIONS: The majority of existing robotic platforms are currently at the preclinical to developmental and exploratory stage of evaluation. Using the IDEAL framework will ensure that emerging robotic platforms are fully evaluated with long-term data, to inform the surgical workforce and ensure patient safety.

Keywords

Device Evaluation Innovation Robotics Validation

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MeSH Term

Humans
Robotics
Minimally Invasive Surgical Procedures
Natural Orifice Endoscopic Surgery
Gynecology
Robotic Surgical Procedures
Laparoscopy
Journal Article Review
Article has an altmetric score of 10

Word Cloud

Created with Highcharts 10.0.0stageplatformsroboticsurgicalIDEALsystems12minimallyinvasivetechnologyreviewstatusemergingdatafullyevaluated3includingnaturalorificesurgeryendoluminalevaluatevalidationcurrentFramework460ensureEvaluationBACKGROUND:rapidadoptionroboticswithinspecialtiesalsoseenexplosionnewmulti-singleporttransluminalendoscopicNOTES"on-demand"aimsMISusingMETHODS:scopingexploringdevicesusedevelopedperformedgeneralgynaecologyurologycardiothoracicsSystemsoperatingpurelyoutsideabdomenthoraxexcludedPubMedGoogleScholarjournalreportsinformationpublicdomaincollectedcompanyapproachedviaemailvirtualinterviewdiscoverqualitycheckinternationallyacceptedtoolnovelconsistingfourstages:ideadevelopment/explorationassessmentsurveillancesynonymousassignedreviewingpublishedliteratureRESULTS:21companies23differentidentifiedcollection13nationaland/orinternationalregulatoryapproval17multiport2b2apre-IDEALsingle-portnoneCONCLUSIONS:majorityexistingcurrentlypreclinicaldevelopmentalexploratoryevaluationUsingframeworkwilllong-terminformworkforcepatientsafetyDeviceInnovationRoboticsValidation

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