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Background:
Systematic Review

New Robotic Platforms in General Surgery: What’s the Current Clinical Scenario?

by
Francesco Marchegiani
1,
Leandro Siragusa
2,
Alizée Zadoroznyj
1,
Vito Laterza
1,
Orsalia Mangana
1,
Carlo Alberto Schena
1,
Michele Ammendola
3,
Riccardo Memeo
4,
Paolo Pietro Bianchi
5,
Giuseppe Spinoglio
6,
Paschalis Gavriilidis
7 and
Nicola de’Angelis
1,*
1
Unit of Colorectal and Digestive Surgery, DIGEST Department, Beaujon University Hospital, AP-HP, University of Paris Cité, Clichy, 92110 Paris, France
2
Department of Surgical Sciences, University of Rome “Tor Vergata”, Viale Oxford 81, 00133 Rome, Italy
3
Science of Health Department, Digestive Surgery Unit, University “Magna Graecia” Medical School, 88100 Catanzaro, Italy
4
Unit of Hepato-Pancreato-Biliary Surgery, General Regional Hospital “F. Miulli”, 70021 Acquaviva delle Fonti, Italy
5
Division of General and Robotic Surgery, Department of Health Sciences, San Paolo Hospital, University of Milan, 20142 Milan, Italy
6
Research Institute Against Digestive Cancer (IRCAD), 67000 Strasbourg, France
7
Department of Surgery, Saint Helena General Hospital, Jamestown, Saint Helena STHL 1ZZ, South Atlantic Ocean, UK
*
Author to whom correspondence should be addressed.
Medicina 2023, 59(7), 1264; https://doi.org/10.3390/medicina59071264
Submission received: 13 June 2023 / Revised: 1 July 2023 / Accepted: 4 July 2023 / Published: 7 July 2023
(This article belongs to the Section Surgery)

Abstract

:
Background and Objectives: Robotic surgery has been widely adopted in general surgery worldwide but access to this technology is still limited to a few hospitals. With the recent introduction of new robotic platforms, several studies reported the feasibility of different surgical procedures. The aim of this systematic review is to highlight the current clinical practice with the new robotic platforms in general surgery. Materials and Methods: A grey literature search was performed on the Internet to identify the available robotic systems. A PRISMA compliant systematic review was conducted for all English articles up to 10 February 2023 searching the following databases: MEDLINE, EMBASE, and Cochrane Library. Clinical outcomes, training process, operating surgeon background, cost-analysis, and specific registries were evaluated. Results: A total of 103 studies were included for qualitative synthesis after the full-text screening. Of the fifteen robotic platforms identified, only seven were adopted in a clinical environment. Out of 4053 patients, 2819 were operated on with a new robotic device. Hepatopancreatobiliary surgery specialty performed the majority of procedures, and the most performed procedure was cholecystectomy. Globally, 109 emergency surgeries were reported. Concerning the training process, only 45 papers reported the background of the operating surgeon, and only 28 papers described the training process on the surgical platform. Only one cost-analysis compared a new robot to the existing reference. Two manufacturers promoted a specific registry to collect clinical outcomes. Conclusions: This systematic review highlights the feasibility of most surgical procedures in general surgery using the new robotic platforms. Adoption of these new devices in general surgery is constantly growing with the extension of regulatory approvals. Standardization of the training process and the assessment of skills’ transferability is still lacking. Further studies are required to better understand the real clinical and economical benefit.

1. Introduction

Twenty-two years after the clinical introduction of the first Intuitive Surgical Da Vinci system, only a limited percentage of general surgery procedures are performed via robotic approach in Western countries [1]. In addition, there is a great disparity between developed and low-income countries where robotic surgery remains unsustainable despite its potential technical advantages [1,2].
Historically, AESOP® and ZEUS, both produced by the American Computer Motion, were the first robotic surgical systems adopted in general surgery [3]. In 2003, after long legal action, American Computer Motion merged with its main competitor, Intuitive Surgical, which had been founded eight years prior [3]. The company developed several generations of master-slave multi-arm robots protecting their products thanks to the registration of more than 7000 patents which was the main barrier for the development of contenders [4,5]. After twenty years, the first registered patents are progressively expiring allowing the development of competing products [6]. The twenty years monopoly constituted an enormous advantage for the Intuitive Surgical company, whose products were adopted by most surgical specialties, thanks to the claimed technical advantages over laparoscopy provided by 3D imaging, magnification, dexterity, tremor filtration, motion scaling and a quick learning curve [5]. At the beginning of 2023, more than 11 millions robotic surgeries have been performed worldwide with Intuitive Surgical Da Vinci robots, with over 7500 platforms installed worldwide [7].
Nevertheless, the scenario is changing because new robotic platforms have been recently introduced into the market with several new architectures (e.g., modular platforms). Their use appeared to be feasible, but the associated surgical results and clinical effectiveness still require further investigation [8].
The aim of this systematic review was to evaluate the adoption of these new surgical robotic systems in general surgery in terms of clinical data, technical aspects, costs, and learning curve.

2. Materials and Methods

2.1. Search Strategy and Data Sources

The systematic review was performed according to the Cochrane Collaboration-specific protocol [9] and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement [10].
A first search was performed in grey literature and on the internet to identify the newly available robotic platforms, different from the Intuitive Surgical Da Vinci S®/Si®/** in the existing publications.
According to the PICOS format, the following items were used to select the retrieved articles:
  • P, population: patients > 18 years undergoing a robotic intervention with a platform different from Intuitive Surgical multiport Da Vinci S®/Si®/** their products in collaboration with clinicians, trying to differentiate their approach and to collect data from the clinical activities. Two recently published registry analyses concerning the adoption of the two mainly diffused new generation robots, namely Asensus Senhance® and CMR Versius®, reported 871 and 2083 cases, respectively [94,124]. The published databases will make the comparison of clinical outcomes simpler and more transparent. Furthermore, the registry promotion distinguished the competitors from Da Vinci.
    The next stage of development will focus on the producer partnership to improve and ameliorate the existing products in order to better compete in a market still dominated by a single leader. The vision capabilities will be augmented thanks to the new technological standards, as announced in February 2023 by Asensus with its new Luna Surgical System endowed with a 4K-3D vision without the need to wear glasses.
    In terms of clinical data analysis, the next major advancement will entail the adoption of artificial intelligence as proposed by Asensus or Medicaroid, in order to digitalize the surgical practice, opening the door to new opportunities such as the telesurgery [149,150].
    The present review presents some limitations mainly related to the low-quality of existing evidence, the design and the small sample of studies included, and the absence of data on several robotic platforms. Nevertheless, this systematic review provides a good snapshot of the real clinical application of the recently introduced platforms in general surgery.

5. Conclusions

Robotic procedures with new robotic devices have been progressively described in hepatobiliary, colorectal, abdominal wall, upper gastrointestinal, endocrine and breast surgery. Despite the low-quality of the current evidence, this review suggests that most surgical interventions are feasible with no technical issues. More platforms are obtaining clinical approvals and their continuous development will be likely stimulated by the Asian market. However, the absence of an international training curriculum and credentialing program hinders the ability to evaluate surgical proficiency and the transferability of skills across different devices. Thus, the future holds substantial technological innovation whose clinical evidence is yet to be established.

Supplementary Materials

The following supporting information can be downloaded at: https://mdpi.longhoe.net/article/10.3390/medicina59071264/s1, Table S1: Mixed series; Table S2: Hepatopancreatobiliary surgery; Table S3: Colorectal surgery; Table S4: Abdominal wall surgery; Table S5: Endocrine surgery; Table S6: Upper gastrointestinal and bariatric surgery; Table S7: Breast surgery.

Author Contributions

Conceptualization, F.M. and N.d.; methodology, F.M., L.S. and C.A.S.; data curation, F.M., L.S., A.Z., V.L., O.M. and C.A.S.; investigation, F.M., L.S., A.Z., V.L., O.M., C.A.S., M.A., R.M., P.P.B., G.S., P.G. and N.d.; writing—original draft preparation, F.M., L.S., A.Z., V.L., O.M. and C.A.S.; writing—review and editing, M.A., R.M., P.P.B., G.S., P.G. and N.d.; visualization, F.M., L.S., A.Z., V.L., O.M., C.A.S., M.A., R.M., P.P.B., G.S., P.G. and N.d.; supervision, R.M. and N.d. All authors have read and agreed to the published version of the manuscript.

Funding

This research received no external funding.

Institutional Review Board Statement

Not applicable.

Informed Consent Statement

Not applicable.

Data Availability Statement

No new data were created or analyzed in this study. Data sharing is not applicable to this article.

Conflicts of Interest

The authors declare no conflict of interest.

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Figure 1. PRISMA flowchart of the literature search and selection.
Figure 1. PRISMA flowchart of the literature search and selection.
Medicina 59 01264 g001
Table 1. Number of interventions according to the surgical specialties and the type of robotic platforms.
Table 1. Number of interventions according to the surgical specialties and the type of robotic platforms.
Robotic
Platform
Intuitive Surgical
Da Vinci SP®
CMR
Versius®
Asensus
Senhance®
Wego
MicroHand S/SII
Medrobotics
Flex®
Meerecompany
Revo-i
Medtronic
Hugo RAS
Total Cases Per
Specialty
Surgical
Specialty
Hepatobiliary3864221149601701035
Colorectal781692512093301741
Abdominal wall89973450000531
Endocrine2985120000315
Upper GI4691932000124
Breast7300000073
Total cases per platform928762741337331712819
Table 2. Regulatory approvals and available information of the robotic platforms.
Table 2. Regulatory approvals and available information of the robotic platforms.
Clinically Adopted Platforms
CompanyProduct NameCountryRegulatory ApprovalsMarketing Information
(n. Procedures/Platform)
MedtronicHugo RASUSFDA: ongoing
CE-mark: general surgery; urology; gynecology
Australian TGA: urology; gynecology
Health Canada: general surgery
MHLW PMDA Japan: urology; gynecology
NR
Cambridge Medical RoboticsVersius®EnglandCE-mark: general surgery; urology; gynecology; thoracic surgery
Australian TGA: general surgery; urology; gynecology
Anvisa Brazil: general surgery; urology; gynecology
Other countries: India; Pakistan; Egypt
10,000 procedures performed (March 2023) [114]
>100 installed platforms (November 2022) [115]
Intuitive SurgicalDa Vinci SP®USFDA: urology; transoral procedures
MHLW PMDA Japan: urology; gynecology; general surgery; thoracic surgery; transoral
MFDS Korea: urology; general surgery; gynecology; thoracic surgery; transoral
NMPA China: yes, not specified
121 installed platform (December 2022) [116]
A’design award winner 2019
Medrobotics Corp.Flex® Robotic SystemUSFDA: transoral; colorectal; general surgery; gynecology; thoracic surgery
CE-mark: colorectal
Australian TGA: colorectal
Bankrupt of the producing company
Asensus
(formerly TransEnterix)
Senhance® ALF-XUSFDA: general surgery; gynecology. Pediatric surgery expected in 2023
CE-mark: general surgery; gynecology; pediatric surgery
MHLW PMDA Japan: urology; gynecology; general surgery; thoracic surgery
Roszdravnadzor—Russia: yes, not specified
Taiwan: yes, not specified
>10,000 procedures performed (February 2023)
>49 installed platforms between 2016 and 2022 [117]
Meerecompany Inc.Revo-iSouth KoreaMFDS Korea: urology; gynecology; general surgeryNR
WegoMicro Hand SChinaNMPA China: general surgeryReddot award winner 2022
Platforms under Clinical Investigation
CompanyProduct NameCountryRegulatory ApprovalsMarketing Information
MedicaroidHinotoriJapanMHLW PMDA Japan: urology; gastrointestinal; gynecology840 procedures (December 2022)
28 installed platforms (September 2022) [118]
Avatera MedicalAvateraGermanyCE-mark: urology; gynecologyFist clinical procedure in May 2022 [119]
DistalmotionDexterSwitzerlandCE-mark: general surgery; gynecology4 installed platforms [120]
iF design award 2020
Moon SurgicalMaestroUSFDA: laparoscopic procedures
CE-mark: laparoscopic procedures
30 procedures performed [121]
Virtual IncisionMIRAUSFDA: completed IDE for bowel resections. De novo classification pathway ongoingNR
Titan Medical Inc.ENOS (formerly SPORT)CanadaFDA: planned in 2023
CE-mark: planned in 2023/24
NR
SS InnovationMantraIndiaFDA: planned in 2023
CE-mark: planned in 2023
Other countries: India
5 installed platforms
100 procedures performed [122]
Rob Surgical Systems SBitrack SystemSpainNRFirst clinical trial ongoing [123]
US: United States; FDA: food and drug administration; CE: Conformité Europeenne; TGA: Therapeutic Goods Administration; MHLW PMDA: Ministry of Health, Labour and Welfare Pharmaceuticals and Medical Devices Agency; NR: not reported; MFDS: Ministry of Food and Drug Safety; NMPA: National Medical Products Administration; IDE: Investigational Device Exemption.
Table 3. Summary of the overall characteristics of the robotic platforms.
Table 3. Summary of the overall characteristics of the robotic platforms.
Robotic PlatformPatient Chart ArchitectureConsole ArchitectureOperative Arms No.TrocarsInstrumentsInstruments’ ReusabilityAdvanced Energy
Medtronic
Hugo RAS
ModularOpen3CommercialWristedReusables (some disposables)NA
Cambridge Medical Robotics
Versius®
ModularOpen3CommercialWristedReusablesNA
Intuitive Surgical
Da Vinci SP®
Single portClosed3Dedicated + commercialWristedReusablesNA
Medrobotics Corp.
Flex® Robotic System
Flexible system/2/WristedDisposablesNA
Asensus
Senhance® ALF-X
ModularOpen3CommercialRigid with a kit of wristedReusablesUltrasonic (rigid)
Meerecompany Inc.
Revo-i
MultiarmClosed3CommercialWristedReusablesUltrasonic (rigid)
Wego
Micro Hand S
MultiarmOpen2DedicatedWristedReusablesUltrasonic (rigid)
Medicaroid
Hinotori
MultiarmSemi-open3DedicatedWristedReusablesNA
Avatera Medical
Avatera
MultiarmSemi-open3NRWristedDisposablesNA
Distalmotion
Dexter
ModularOpen (with laparoscopic screen)2CommercialWristedDisposablesNA
Moon Surgical
Maestro
Multiport instrument holder/1Commercial//NA
Virtual Incision
MIRA
Single portOpen2NRWristedReusablesNA
Titan Medical Inc.
ENOS (formerly SPORT)
Single portOpen2NRWristedReusablesNA
SS Innovation
Mantra
ModularOpen3DedicatedWristedReusablesNA
Rob Surgical Systems S
Bitrack System
MultiarmOpen3CommercialWristedDisposablesNA
NR: not reported; NA: not available.
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Marchegiani, F.; Siragusa, L.; Zadoroznyj, A.; Laterza, V.; Mangana, O.; Schena, C.A.; Ammendola, M.; Memeo, R.; Bianchi, P.P.; Spinoglio, G.; et al. New Robotic Platforms in General Surgery: What’s the Current Clinical Scenario? Medicina 2023, 59, 1264. https://doi.org/10.3390/medicina59071264

AMA Style

Marchegiani F, Siragusa L, Zadoroznyj A, Laterza V, Mangana O, Schena CA, Ammendola M, Memeo R, Bianchi PP, Spinoglio G, et al. New Robotic Platforms in General Surgery: What’s the Current Clinical Scenario? Medicina. 2023; 59(7):1264. https://doi.org/10.3390/medicina59071264

Chicago/Turabian Style

Marchegiani, Francesco, Leandro Siragusa, Alizée Zadoroznyj, Vito Laterza, Orsalia Mangana, Carlo Alberto Schena, Michele Ammendola, Riccardo Memeo, Paolo Pietro Bianchi, Giuseppe Spinoglio, and et al. 2023. "New Robotic Platforms in General Surgery: What’s the Current Clinical Scenario?" Medicina 59, no. 7: 1264. https://doi.org/10.3390/medicina59071264

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