10.14639/0392-100X-N0688
 Objective. This prospective, non-randomised study documents our initial experience using the Flex® Surgical System for transoral surgery in Italy. Methods. All patients who underwent transoral robotic surgery using the Medrobotics® Flex® Robotic System (Raynham, MA, USA) between March 2018 and April 2019 were reviewed. Rates of successful surgery, surgical time and complications were evaluated. 43 surgical procedures were performed in the study. The average age was 62.56 years (range 36-90 years). The Flex® system was used successfully in surgery of the base of the tongue, palatine tonsils, supraglottis, hypopharynx and glottis, which was the most frequent target. Results. All procedures were successfully completed. There were no intraoperative or serious postoperative complications, with no cases of intraoperative haemorrhage. Conclusions. This is the first study in Italy evaluating the use of the Flex® system to safely resect lesions in the oral cavity, larynx and pharynx.
application/xml
1827-675X
688
en
Michele Barbara
https://creativecommons.org/licenses/by-nc-nd/4.0
ACTA Otorhinolaryngologica Italica
flexible endoscope
Flexible transoral robotic surgery: the Italian experience
Text.Serial.Journal
https://www.actaitalica.it/
41
Head and neck
2021-03-19
2020-04-28
2021-03-19
2021-03-24
24-30
1
Michele Barbara
2021/03/19
10.14639/0392-100X-N0688
24
Otolaryngology and Head and Neck Unit, Ospedale “Mons. Dimiccoli”, Barletta (BAT), Italy
1827-675X
flexible endoscope
en
30
Flexible transoral robotic surgery: the Italian experience
https://www.actaitalica.it/article/download/688/521
41
ACTA OTORHINOLARYNGOLOGICA ITALICA 2021;41:24-30; doi: 10.14639/0392-100X-N0688




Head and neck


Flexible transoral robotic surgery:
the Italian experience
Chirurgia robotica transorale flessibile: l’esperienza italiana
Francesco Barbara, Francesco Cariti, Valentina De Robertis, Michele Barbara
Otolaryngology and Head and Neck Unit, Ospedale “Mons. Dimiccoli”, Barletta (BAT), Italy


SUMMARY
Objective. This prospective, non-randomised study documents our initial experience using
the Flex® Surgical System for transoral surgery in Italy.
Methods. All patients who underwent transoral robotic surgery using the Medrobotics®
Flex® Robotic System (Raynham, MA, USA) between March 2018 and April 2019 were
reviewed. Rates of successful surgery, surgical time and complications were evaluated. 43
surgical procedures were performed in the study. The average age was 62.56 years (range
36-90 years). The Flex® system was used successfully in surgery of the base of the tongue,
palatine tonsils, supraglottis, hypopharynx and glottis, which was the most frequent target.
Results. All procedures were successfully completed. There were no intraoperative or seri-
ous postoperative complications, with no cases of intraoperative haemorrhage.
Conclusions. This is the first study in Italy evaluating the use of the Flex® system to safely
resect lesions in the oral cavity, larynx and pharynx.
KEY WORDS: larynx, pharynx, transoral surgery, flexible endoscope

RIASSUNTO                                                                                         Received: April 28, 2020
Obiettivo. Questo studio prospettico, non randomizzato, documenta l’esperienza iniziale con       Accepted: October 8, 2020
il sistema chirurgico Flex® nella chirurgia transorale in Italia tra Marzo 2018 ed Aprile 2019.
Metodi. Sono state eseguite 43 procedure chirurgiche su 41 pazienti con età media di 62,56        Correspondence
anni (intervallo 36-90 anni). Sono stati valutati i tassi di successo dell’intervento chirurgi-   Francesco Barbara
co, il tempo chirurgico e le complicanze. Il sistema Flex® è stato utilizzato nella chirurgia     Otolaryngology and Head and Neck Unit, Ospedale
della base della lingua, delle tonsille palatine, della regione sovraglottica, dell’ipofaringe    “Mons. Dimiccoli”, Barletta (BAT), Italy
                                                                                                  E-mail: francescobarbara89@gmail.com
e della glottide: quest’ultimo è stato il target chirurgico più frequente.
Risultati. Tutte le procedure sono state completate con successo. Non ci sono state compli-
                                                                                                  Funding
canze intraoperatorie e postoperatorie gravi, nè casi di emorragia.
                                                                                                  None.
Conclusioni. Questo è il primo studio in Italia in cui viene utilizzato il sistema Flex® per la
resezione di lesioni faringee e laringee e ne documenta l’affidabilità e la sicurezza.            Conflict of interest
PAROLE CHIAVE: laringe, faringe, chirurgia transorale, endoscopio flessibile                      The Authors declare no conflict of interest.


                                                                                                    How to cite this article: Barbara F, Cariti F,
                                                                                                    De Robertis V, et al. Flexible transoral robotic
Introduction                                                                                        surgery: the Italian experience. Acta Otorhi-
                                                                                                    nolaryngol Ital 2021;41:24-30. https://doi.
In recent decades, transoral surgery for tumours of the upper aerodigestive                         org/10.14639/0392-100X-N0688
tract has become a standard procedure for treating different pathologies in
                                                                                                  © Società Italiana di Otorinolaringoiatria
this region at the early and/or intermediate stages, although sometimes there                     e Chirurgia Cervico-Facciale
may be procedural difficulties depending on anatomical variations of the pa-
tient 1. Over the years, transoral laser microsurgery (TLM) has been proven to                                   OPEN ACCESS
be effective in treating neoplasms of the upper aerodigestive tract, especially                   This is an open access article distributed in accordance with
                                                                                                  the CC-BY-NC-ND (Creative Commons Attribution-Non-
of the larynx, while achieving satisfactory oncological results and with bet-                     Commercial-NoDerivatives 4.0 International) license. The
ter functionality compared to open reconstructive approaches. However, some                       article can be used by giving appropriate credit and mentio-
                                                                                                  ning the license, but only for non-commercial purposes and
hypopharyngeal and laryngeal lesions remain difficult to visualise and treat                      only in the original version. For further information: https://
through a transoral, surgical approach 2,3.                                                       creativecommons.org/licenses/by-nc-nd/4.0/deed.en




24
                                                                Feasibility of flexible transoral robotic surgery for head and neck procedures




Transoral robotic surgery (TORS) is a recent approach in        the surgical target is limited 16. The development of new, la-
managing pharyngeal and supraglottic neoplasms. The use         ryngeal robotic arm, flexible micro-instruments and curved
of 3D HD angled endoscopes combined with robotic arms           laryngeal blades as a component of the Flex® Retractor
allows better exposure, visualisation and evaluation of ana-    System allows surgeons to easily reach the glottic plane
tomical regions that are otherwise difficult to manage with     with excellent exposure and to operate safely. The purpose
TLM 4. The most commonly used robotic system in head            of this study is to evaluate the flexible robotic system in la-
and neck surgery is the da Vinci Si® HD (Intuitive Surgi-       ryngeal transoral robotic surgery of the head and neck. We
cal®, Sunnyvale, CA, USA), through which surgeons are           demonstrate our experience with the Flex® Robotic System
able to perform procedures in the pharyngeal region 5, at       on the glottic region as this anatomy has not been the focus
the base of the tongue and in some laryngeal sites, mainly      of previous clinical studies.
in the supraglottic region 6. However, there are some limi-
tations which are mainly caused by the conflict between         Materials and methods
rigid robotic arms that may result in obstruction at the
surgical site and limitation of movement. Unlike this well-     From March 2018 to April 2019, a prospective, non-ran-
known system, which was originally designed for surgery         domised study, approved by the local ethics committee,
within larger cavities (such as abdominal and pelvic sur-       was carried out at our Department to assess the safety, ef-
gery), a new flexible robotic system – the Flex® Robotic        ficacy and potential of the flexible robotic system in the
System (Medrobotics®, Raynham, MA, USA) – has been              treatment of laryngeal lesions. A total of 41 patients were
developed to expand the field of TORS by responding spe-        enrolled and treated. The average patient age was 62.56
cifically to the unmet needs of minimally invasive surgery      (range 36-90) and, of these, 28 patients were men and 13
of the upper aerodigestive tract 7. This is a hybrid technol-   patients were women.
ogy, combining the flexibility of an endoscope to gain ac-      A total of 43 surgical procedures were performed because
cess to the surgical site and capable of becoming rigid to      in 2 cases two separate procedures were performed (in the
perform the procedure. This technology is described as a        first, two laryngeal neoformations and, in the second, a
hybrid because, on one hand, it uses the characteristics of     laryngeal neoformation and a pharyngeal neoformation)
flexible endoscopy, offering 102° of freedom in angular         (Tab. I). Six procedures (13.95%) were performed for a
motion, and, on the other, is capable of navigating in non-     pharyngeal lesion, and 37 (86.05%) for laryngeal lesions
linear spaces and becoming rigid near the surgical site 8,9.    (Tab. II). All patients underwent a pre-operative visit and
After demonstrating feasibility and safety with successful      fibre-optic laryngoscopy with NBI. All patients spent one
cadaver dissections, the system obtained the CE Mark in         night in hospital. A new dedicated retractor was used in
March 2014 and the first patients were treated clinically       all procedures (Flex® Retractor System: Medrobotics). Po-
in Europe beginning in July 2014 10,11. The surgical site is    sitioning of the retractor was video-assisted using a Gli-
visualised using a 3D video camera incorporated into the        deScope® Core (Verathon) portable video laryngoscope
distal end of the flexible endoscopic arm. The robotic arm      supplied by our anaesthetists. Nasotracheal intubation was
has two accessory instrument channels for the delivery of       chosen in all procedures; in our opinion, this allows better
3.5-mm flexible instruments and, recently, 2-mm flexible        exposure and less obstruction of the surgical field using
instruments for laryngeal microsurgery. These instruments       a 5-mm armored endotracheal tube. All procedures were
provide haptic feedback and allow the surgeon to have full      performed by the same surgeon and nursing team. Each
control of the tip of the instrument. The system consists of    procedure required the use of two Flex® Instruments. Ei-
two components: the 1) Flex® Cart, which carries the Flex®      ther a Flex® Monopolar Maryland Dissector, a Flex® Fe-
base, the Flex® Scope, and 2) the Flex® Console which has       nestrated Grasper or a Micro Flex® Triangle Grasper were
a 2D touchscreen and physician controller. The flexible ro-     selected as a grasping and retraction instrument. A Flex®
botic arm is controlled by the physician controller and a 2D    Monopolar Needle Knife or a Flex® Monopolar Spatula
touchscreen monitor. A reusable 3DHD camera and light           was used as a cutting tool in 40 procedures (93%). In 3 of
source consisting of four LED lights are mounted on the         the laryngeal procedures (7%), however, a Micro Flex®
tip of the flexible robotic arm. Thanks to a 3D monitor and     Sickle Knife, a cold cutting instrument, was preferred. In
passive 3D glasses, all of the room is able to follow the       all operations, a suction tube for smoke evacuation was
surgical procedure in real time 12.                             connected to the Flex® Retractor and a second operator
There are numerous studies in literature in which Flex tech-    helped the surgeon with the suction and traction of tissues
nology has been applied in the pharyngeal and supraglottic      using an external rigid double-edged curved laryngeal suc-
regions 13-15. However, clinical work on the glottic plane as   tion unit.



                                                                                                                                          25
F. Barbara et al.




Table I. In 41 patients, 43 surgical procedures were performed.
 Patient no.         Sex         Age,         Malignant/benign          Histology                 Surgical          Site       Subsite
                                   Y                (M/B)                                        procedure
 1                    M          64                  B                 Laryngocele                 Resection         L          Vestibule
 2                    M          70                  B                  Dysplasia              Type II cordectomy    L         Vocal fold
 3                    M          63                  B                   Synechia                  Resection         L         Vocal fold
 4                    M          64                  B                     Cyst                    Resection         O           Tonsil
 5                    M          65                  B                  Dysplasia             Type III cordectomy    L         Vocal fold
 6                    M          58                  B                 Laryngocele                 Resection         L          Vestibule
 7                    M          71                  M                  SCC pT1a             Type Va cordectomy      L         Vocal fold
 8                    M          72                  M                  SCC pT1a              Type III cordectomy    L         Vocal fold
 9                    M          57                  B                  Dysplasia              Type I cordectomy     L         Vocal fold
 10                   M          64                  B                   Synechia                  Resection         L     Infraglottic cavity
 11                   F          68                  M                  SCC pT1a              Type III cordectomy    L         Vocal fold
 12                   F          56                  B                     Cyst                    Resection         O      Base of tongue
 13                   F          60                  B                     Cyst                    Resection         L          Epiglottis
 14                   F          62                  B                     Cyst                    Resection         O      Base of tongue
 15                   F          45                  B               Reinke oedema                 Resection         L         Vocal fold
 16                   M          64                  B                 Mucosal flap                Resection         L          Vestibule
 16 BIS               M          64                  B            Sovraglottic obstruction       Epiglottectomy      L          Epiglottis
 17                   M          66                  M                  SCC pT1a              Type Va cordectomy     L         Vocal fold
 18                   M          70                  B                  Papilloma                  Resection         L     Infraglottic cavity
 19                   M          71                  M                  SCC pT1b              Type VI cordectomy     L         Vocal fold
 20                   M          65                  M                  SCC pT1a              Type III cordectomy    L         Vocal fold
 21                   M          56                  B                     Cyst                    Resection         L          Epiglottis
 22                   M          90                  M                   SCC pT1                  Bot resection      O      Base of tongue
 23                   M          62                  B                  Taratoma                 Tonsillectomy       O           Tonsil
 24                   F          67                  B                     Polyp                   Resection         L         Vocal fold
 25                   M          70                  M                  SCC pT1a              Type IV cordectomy     L         Vocal fold
 26                   F          65                  B                     Cyst                    Resection         L         Vocal fold
 27                   F          58                  B                     Cyst                    Resection         L          Vestibule
 28                   M          66                  B                 Laryngocele                 Resection         L          Vestibule
 29                   F          36                  B                     Cyst                    Resection         L         Vocal fold
 30                   F          46                  B                     Cyst                    Resection         L         Vocal fold
 31                   F          69                  M                  SCC pT1a              Type III cordectomy    L         Vocal fold
 32                   M          71                  M               Mixed tumour T1             Epiglottectomy      L          Epiglottis
 33                   M          69                  M                  SCC pT1a              Type iii cordectomy    L         Vocal fold
 34                   F          58                  B                 Laryngocele                 Resection         L          Vestibule
 35                   M          43                  M                SCC pT1a N2            Epiglottectomy + snd    L          Epiglottis
 36                   M          41                  M                   SCC pT1                 Epiglottectomy      L          Epiglottis
 37                   F          52                  B                     Cyst                    Resection         L         Vocal fold
 38                   M          74                  B                     Cyst                    Resection         O           Tonsil
 38 BIS               M          74                  B                     Cyst                    Resection         L          Vestibule
 39                   M          71                  B                  Dysplasia             Type III cordectomy    L         Vocal fold
 40                   M          70                  B                  Dysplasia             Type III cordectomy    L         Vocal fold
 41                   M          56                  B                Reinke edema                 Resection         L         Vocal fold




26
                                                                  Feasibility of flexible transoral robotic surgery for head and neck procedures




Table II. Surgical subsites.                                      Table III. Benign lesions. Anatomical subsites and histologies.
 Surgical subsite                    N               Tot           Surgical subsite             N         Tot               Histology
 Pharynx                                              6            Pharynx                                   5
 Tonsil                              3                             Tonsil                         3                           Cyst (2),
 Base of tongue                      3                                                                                      Taratoma (1)
 Larynx                                              37            Base of tongue                 2                           Cyst (2)
 Epiglottis                           6                            Larynx                                   20
 Vestibule                            7                            Epiglottis                     3                          Cyst (2),
                                                                                                                     Sovraglottic obstriction (1)
 Vocal fold                          22
                                                                   Vestibule                      7                      Laryngocele (4),
 Infraglottic cavity                  2                                                                                  Mucosal flap (1),
                                     Tot             43                                                                       Cyst (2)
                                                                   Vocal fold                     8                    Synechia (1), Reinke
                                                                                                                            edema (2),
                                                                                                                             Polyp (1),
Setup time, retractor positioning time, surgical procedure                                                                   Cyst (4),
time and resection time were calculated during surgery. Ac-        Infraglottic cavity            2                        Synechia(1),
cess to the surgical site and exposure were evaluated with                                                                 Papilloma(1)
a score from 1 to 5 (1 = impossible to expose, 5 = easy to                                        Tot       25
expose). The score was given by the single operator.
The following aspects were investigated:
Postoperative pain at 24 h and 48 h was rated on a scale          There were 5 dysplastic lesions (11.6%), of which 3 were
of 0 to 10 (0 = no pain, 10 = severe pain) and the presence       SIN I (60%), 1 was SIN II (20%) and 1 was SIN III (20%).
of intraoperative complications, postoperative complica-          The margins were negative in two cases. In one case, the
tions (0-7 days following surgery) and surgical outcomes          deep margin was close and, after two months of follow-up
(> 7 days) were also evaluated.                                   and NBI examinations, due to the presence of pseudo-gran-
All patients underwent endoscopic examinations on the             ulomatous tissue in the surgical site, we preferred to opt for
first, seventh and fourteenth day following surgery.              TOLS revision surgery, with negative resection margins.
Patients who had malignant lesions (13; 30%) or dysplasia         (Tab. IV).
(5; 11.6%) followed the standard follow-up protocol as per        There were 13 malignant lesions (30%), of which 1 (7.7%)
institutional guidelines.                                         was pharyngeal and 12 (92.3%) were laryngeal. Specifi-
                                                                  cally, the pharyngeal lesion involved the base of the tongue,
Results                                                           while the laryngeal lesions were localised in 3 (25%) cases
                                                                  in the supraglottic region and in 9 (75%) cases in the glottic
The average setup time was 15.07 minutes (range 7-40), dem-       plane. In 12 cases, the histology was squamous cell car-
onstrating a quick learning curve, as the first case setup time   cinoma (92.3%); in a single case, the histological diagno-
was 40 minutes and the most recent cases ranged between           sis was a mixed tumour (7.7%). Resection margins were
7-15 minutes. The average retractor positioning time was          negative in 11 (84.6%) cases. Margins were close in 2 cases
10.82 minutes (range 4-26). Exposure was possible in 100%         (15.4%). In one case, the patient underwent TOLS revision
of cases and the procedure was successfully completed in          surgery one month after the first operation due to persis-
all patients without the need for conversion to another type      tence of pathology, although the margins were negative at
of transoral surgery (TOLS: Trans Oral Laryngeal Surgery,         the histological examination. In one case, a contralateral
TOUSS: Trans Oral UltraSonic Surgery). The mean time for          neck dissection to the lesion was carried out for N+ on one
the surgical procedure was 32.78 minutes (range 15-75). The
mean resection time was 24.74 minutes (range 4-55). The
mean exposure score was 3.42 (range 2-5). There were no           Table IV. Dysplastic lesions.
cases where the exposure score was 1 or where a site could         Surgical subsite                   N      Tot              Histology
not be exposed.                                                    Larynx                                        5
There were 25 (58.14%) benign lesions, of which 5 (20%)            Vocal fold                         5                        SIN I (3),
were pharyngeal and 20 (80%) were laryngeal. The ana-                                                                          SIN II (1),
tomical subsites of the two surgical targets and histologies                                                                   SIN III (1)
are shown in Table III.                                                                            Tot           5




                                                                                                                                              27
F. Barbara et al.




Table V. Malignant lesions. Staging, grading, location of lesions.        dated the feasibility of using the Flex Robotic System in
 Surgical subsite           N          Tot               Histology        various head and neck procedures 8,9. Lerner et al. 19 dem-
 Pharynx                                1                                 onstrated the possibility of transoral surgical access to the
 Base of tongue             1                       SCC pT1 G1 HPV-       oropharynx and hypopharynx without risks or complica-
 Larynx                                12                                 tions. Additionally, others have demonstrated the feasibility
 Vocal fold                 9                      SCC pT1a G1 (8),       of performing supraglottic laryngectomy, total laryngecto-
                                                    SCC pT1b G1 (1)       my, removal of a Zenker’s diverticulum, thyroid lobectomy,
 Epiglottis                 3                       SCC pT1 G1 (1),       dissection of the neck, removal of the submandibular gland,
                                                    SCC pT1 G2 (1),       cranial base surgery and nasopharyngeal surgery 20,21.
                                                Mixed tumour pT1 G2 (1)   In the literature, there are fewer publications on the Flex®
                            Tot        13                                 Robotic System compared to the da Vinci® system. This is
                                                                          due to the recent introduction of the Flex® Robotic system
                                                                          in transoral surgery.
patient that had already been treated with neck dissection                The Flex® Robotic System obtained the European CE Mark
at another centre. No patients underwent postoperative ad-                (Conformité Européenne) in March 2014 and FDA clear-
juvant therapy. All patients (100%) are currently free of                 ance in July 2015 to allow the use in the oropharynx, hy-
disease. The duration of follow-up ranges from 1 month to                 popharynx and larynx in adults (aged ≥ 22 years). More
11 months. Staging, grading, location of lesions and type of              recently, the CE Mark approval (2016) and FDA clearance
transoral surgery are shown in Table V.                                   (2017) also provides for transanal surgical procedures in
All procedures were successfully completed. There were                    the anus, rectum and distal colon.
no intraoperative complications. In one case, postoperative               The most significant experience in Europe is that of the
arytenoid oedema appeared (one day following the sur-                     University of Essen. In a prospective study (N = 40), Mat-
gery), which was resolved after 12 hours of corticosteroid                theis et al. demonstrated important surgical results using
therapy.                                                                  the Flex system. They showed that 95% of T1 and T2 carci-
At one-month follow-up, we found a granuloma in two pa-                   nomas of the oropharynx, hypopharynx and supraglottis in
tients: in the 1st case the granuloma appeared in the para-               their cohort were accessible, allowing for an oncologically
commissural area and in the 2nd case in the posterior area;               correct resection with no major complications 15. Lang et
both were treated with medical therapy. In one case, we                   al. also demonstrated excellent exposure of the oropharynx
found the appearance of para-commissural leukoplakia                      and the supraglottic larynx, noting that in 75 of 80 patients
near the resection margin, NBI negative, and not in pro-                  with lesions in these locations, exposure and resection was
gression. The postoperative pain score at 24 h and 48 h was               possible. Additionally, they showed that there is a reason-
2.88 and 0.77 of 10, respectively. All patients who under-                able setup time between 9 and 12.4 minutes, demonstrating
went transoral surgery only were discharged on the first                  a shorter setup time with the Flex® Robotic system than that
day following the surgery with an indication for complete                 of the da Vinci system 12. These studies have demonstrated
vocal rest and hyaluronic acid therapy. No patients were                  the feasibility of using this technology in TORS; however,
prescribed antibiotic or anti-inflammatory treatment.                     further studies are needed to support these results in the
                                                                          long term.
Discussion                                                                The American experience has also shown similar and com-
                                                                          parable results. In a multicentre study, Persky et al. suc-
The most commonly used system for TORS in the United                      cessfully used the Flex® system in 66 of 70 cases, demon-
States today is the da Vinci Si® HD (Intuitive Surgical®,                 strating that it can be used to perform complex pharyngeal
Sunnyvale, CA, USA), which has been used since 2005 and                   and laryngeal surgical procedures. In this study, the Flex®
was approved by the Food and Drug Administration (FDA)                    Robotic System was used both for transoral surgical proce-
in 2009 17. Over the years, this system has allowed progress              dures (tonsils) and for procedures with indications similar
in transoral and conservative surgery of the aerodigestive                to those of TOLS surgery. It was concluded that flexible
tract; however, multiple rigid arms limit access to some                  robotic surgery provides better visualisation of the surgi-
hypopharyngeal-laryngeal regions that cannot be exposed                   cal site and greater precision than classic transoral surgery
through line of sight 18.                                                 and allows, with respect to TOLS, three-handed surgery
The Flex® Robotic System (Medrobotics, Raynham, MA,                       (second operator) and the ability to modify both the vis-
USA) is a hybrid approach specifically designed for head                  ual and the cutting angle with a simple wrist movement.
and neck surgery. Animal and cadaveric studies have vali-                 In this study, however, the failures on the glottic plane are



28
                                                                  Feasibility of flexible transoral robotic surgery for head and neck procedures




highlighted: 2 of 4 procedures were not completed (50%).          aerodigestive tract, the surgical site and the experience of
Although the number of patients that underwent surgery in         the operator. It would be useful if the different centres that
these centres on this subsite is too low, the Authors con-        use this technology will follow a standardised algorithm in
clude that anatomical variants (such as macroglossia or la-       the future.
ryngeal anteriorisation), trismus and radiations could make       It would also be interesting to find relevant parameters and
exposure a challenge 14.                                          create a score to identify patients that are difficult to ex-
Therefore, in the literature, the surgical targets where this     pose. In our experience, all the patients were exposed and
surgery was evaluated were the pharynx and the supraglot-         patients with an exposure score of 2 would have been dif-
tic region. There are few experiences on the glottic region.      ficult to expose even with TOLS surgery.
For around 6 months, our multi-specialty department has           The haptic feedback of the instruments is very accurate and
had the new hyper curved blades that allow excellent expo-        it is possible to recognise the consistency and tension of
sure of the glottis using the Flex® Retractor System. Most        different tissues.
of the interventions we carried out were due to vocal cord        In their work, Friedrich et al. 22 concluded that the flexible
lesions. We did not find any complications for either benign      instruments of the Flex® Robotic System allow better haptic
lesions or malignant lesions, and functional and oncologi-        feedback than the da Vinci® system due to the direct transmis-
cal outcomes were good. In fact, only one patient needed          sion of the force of the Flex® Instruments compared to the
revision surgery for recurrence. Although follow-up is less       electromechanical transformation of the da Vinci® system.
than one year, all patients are currently free of disease.        In addition, flexible microinstruments have a moderate force
We think that, while the superiority of robotic surgery vs.       and grip that allow space to be made between tissues to reach
TOLS regarding the supraglottic region is now a fact, in          the surgical targets, inspect anatomical structures such as the
terms of handling, exposure, visualisation and surgical du-       pyriform sinuses and move the tracheal tube. The use and
ration in the glottic region, TOLS has been the standard in       manageability of these instruments is very instinctive, and the
terms of surgical precision. The Flex® technology is con-         learning curve to use them is quick.
stantly evolving, and dedicated engineers bring monthly           Another advantage, in our opinion, is the rapid reposition-
innovations to our attention. We believe that within a few        ing of the Flex® Scope and microsurgical instruments. In
years the Flex® system will achieve the same performance          our experience, two patients were each treated for two dif-
as TOLS on the glottic plane. We will add a fact to this con-     ferent lesions at different anatomical sites. In both cases, it
sideration: in our experience, more than 90% of patients          was not necessary to reposition the retractor and the transi-
were treated with a monopolar cutting instrument. On the          tion from one site to the other was immediate, using the
first day following surgery, fibrin at the surgical site was      Flex® Physician Controller. In addition, the times to reverse
almost nonexistent. This meant no endoscopic medications          (swap) the position of the microlaryngeal instruments are
were required, even when surgery was performed on an-             very fast.
terior commissural neoformations. CO2 laser cutting tools
are also compatible with the Flex® system, but we have no
                                                                  Conclusions
experience with these.
Nasotracheal intubation is very useful because it leaves the      The Flex® Robotic System is a safe instrument that consist-
oral cavity free and the tube runs down against the rear wall     ently provides good surgical exposure to treat benign and
of the pharynx; accordingly, it is less of an obstruction to      malignant lesions of the upper aerodigestive tract. Further
movement of the flexible arm.                                     technological innovations will be needed for better surgical
The 3D view is good, although the monitor needs to be in          precision, especially in the field of phonosurgery, and to
the same line of sight as that of the operator. In our opinion,   better treat more extensive lesions. Choosing the correct re-
the da Vinci® system has a good 3D camera that allows bet-        tractor blade for each individual patient remains fundamen-
ter view of anatomical structures. It is questionable whether     tal to the outcome of the surgery. The increasing number
this type of magnification is indispensable for this surgery.     of ORL centres that utilise the Flex® Robotic System will
Surgery is a single-operator procedure; a second operator         allow more experiences to be shared and will be useful for
sits beside the surgeon and uses a dedicated suction device       development purposes.
that allows the suction of secretions and smoke and helps
surgical micro-instruments with tissue traction.                  References
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