transoral robotic surgery for the management of head and neck tumors: learning curve
TRANSCRIPT
HEAD AND NECK
Transoral robotic surgery for the management of head and necktumors: learning curve
Georges Lawson • Nayla Matar • Marc Remacle •
Jacques Jamart • Vincent Bachy
Received: 1 December 2010 / Accepted: 7 February 2011 / Published online: 2 March 2011
� Springer-Verlag 2011
Abstract Transoral robotic surgery (TORS) is an
emerging technique for the treatment of head and neck
tumors. The objective of this study is to describe our first
steps and present our experience on the technical feasibil-
ity, safety, and efficacy of TORS for the treatment of
selected malignant lesions. From April 2008 to September
2009, 24 patients were enrolled in this prospective trial.
Inclusion criteria were: adults with T1, T2 and selected T3
tumors involving the oral cavity, pharynx, and supraglottic
larynx and a signed informed consent was obtained from
the patient. Exclusion criteria were: tumors not accessible
to TORS after unsuccessful attempts to expose properly the
lesion to operate. The ethical committee’s approval was
obtained to perform this study. Twenty-four patients were
included in this study: 10 supraglottic tumors, 10 pharyn-
geal tumors and 4 oral cavity tumors. Nine patients had T1
tumors, 12 had T2 tumors, and 1 patient had a T3 tumor. In
all cases, tumor resection could be performed by robotic
surgery exclusively and negative resection margins were
achieved with control by frozen section. None of them
received intraoperative reconstruction. None of the patients
required tracheotomy. There was no intraoperative com-
plication related to the use of the robot. The average setup
time was 24 ± 14 min (range 10–60 min). The average
surgical time was 67 ± 46 min (range 12–180 min). Sur-
gical and setup time decreased after the first cases. The
mean hospital stay was 9 days. Oral feeding was resumed
at 3 days. TORS seems to be a safe, feasible, minimally
invasive treatment modality for malignant head and neck
tumors with a short learning curve for surgeons already
experienced in endoscopic surgery.
Keywords Transoral robotic surgery � Squamous cell
carcinoma � Learning curve � Supraglottic neoplasms �Pharyngeal neoplasms � Oral cavity neoplasms �Prospective study
Introduction
Minimally invasive procedures are becoming a target to
reach in many fields of surgery. With this regard, transoral
laser microsurgery (TLM) is the most accepted approach
for early laryngeal and pharyngeal cancers, instead of open
partial procedures, when surgery is indicated [1, 2].
However, even with advancements over the past
30 years, TLM continues to have disadvantages, including
the operator’s distance from the surgical field, the laryn-
goscopes’ limited exposure, and reduced depth perception
with binocular vision [3]. Robotic surgery has the potential
to address the shortcomings of TLM; however, it was
introduced in the field of otolaryngology a decade after its
use in laparoscopic, thoracoscopic, cardiac, and urologic
surgical procedures [4].
Abstract accepted for oral presentation at the European
Laryngological Society, September 1–4, 2010, Vienna, Austria.
G. Lawson � M. Remacle (&) � V. Bachy
Otolaryngology-Head and Neck Surgery Department,
Louvain University Hospital of Mont-Godinne,
Dr Therasse Avenue, No. 1, 5530 Yvoir, Belgium
e-mail: [email protected]
N. Matar
Otolaryngology-Head and Neck Surgery Department,
Hotel Dieu de France Hospital, Bellevue Medical Center,
Saint-Joseph University, Beirut, Lebanon
J. Jamart
Scientific Support Unit, Louvain University Hospital
of Mont-Godinne, Dr Therasse Avenue, No. 1,
5530 Yvoir, Belgium
123
Eur Arch Otorhinolaryngol (2011) 268:1795–1801
DOI 10.1007/s00405-011-1537-7
Transoral robotic surgery (TORS) is defined as surgery
done via the oral cavity that uses a minimum of three arms
and allows bimanual surgical techniques [5]. Its intraop-
erative safety has been assessed in a study by Hockstein
et al. [6] on a fresh human cadaver. They concluded that
the da Vinci surgical system (Intuitive Surgical Inc, Sun-
nyvale, CA) demonstrates a safety profile similar to con-
ventional transoral surgery.
The first robotic procedure on a patient was carried out
in 2005 by McLeod and Melder [7] to excise a vallecular
cyst. In 2006, three patients with tongue base tumors
underwent TORS as part of a prospective clinical trial by
O’Malley et al. [8]. Since then a limited number of series
has been published in the literature [5, 8–11].
The da Vinci Surgical Robot was approved by the Food
and Drug Administration (FDA) for transoral surgery in
2009 [12].
Based on these findings, we decided to use TORS in
procedures where we considered TLM suboptimal
according to our experience and previously published lit-
erature [5, 8–11].
The team members received a specific training (both
theoretical and practical) related to the da Vinci surgical
system. The senior authors joined G. Weinstein (Depart-
ment of Otorhinolaryngology–Head and Neck Surgery,
University of Pennsylvania, Philadelphia) for 2 weeks of
laboratory training and clinical watching.
The objective of this prospective study is to evaluate the
technical feasibility, oncological and functional efficacy,
and safety of TORS in the treatment of malignant lar-
yngeal, pharyngeal and oral cavity tumors. We present the
first 18 months learning curve of a team who has previous
long experience with transoral microscopic laser surgery
[13, 14].
Materials and methods
From April 2008 to September 2009, 24 patients were
enrolled in this prospective trial on TORS using the da
Vinci Surgical Robot.
Inclusion criteria were: patients older than 18 years with
early stage tumors (T1, T2 and selected T3) involving the
oral cavity, base of tongue, pharynx, or supraglottic larynx,
who signed an informed consent. Exclusion criteria were:
medical conditions contraindicating general anesthesia;
patients with tumors not accessible to TORS after prior
evaluation under general anesthesia and attempts to place
various available retractors.
The ethical committee’s approval was obtained to per-
form this study. Procedures were documented with still and
video photography.
Patient’s assessment
We performed a preoperative work-up in all patients
including clinical examination, PET/CT, or CT with con-
trast of the neck, chest X-ray, liver function tests, direct
laryngoscopy and biopsy. During the general anesthesia for
direct laryngoscopy, we tried to position the appropriate
retractor to verify if the patient is eligible for TORS. In our
practice, direct laryngoscopy with biopsies is performed
systematically for every patient with a suspected tumor, to
assess the extension and have a histological confirmation of
the malignant nature of the lesion.
Anesthesia technique
An essential component of this procedure is the ability of
the surgeon to have an unobstructed view of the operating
field, this is why we used the smallest laser-safe endotra-
cheal tube possible for ventilation (inner diameter: 6 mm;
Hi/Lo, Mallinckrodt Medical, Athlone, Ireland). To allow
appropriate positioning of the mouth gag and cheek
retractor, the tube was not fixed with adhesives but care-
fully handled by the surgeon.
Surgical setting
All the procedures were performed in the same operating
room that was chosen between the largest ones available to
allow the placement of the equipments without impeding
the movements of the surgical and nursing team.
After the induction of anesthesia and the placement of
the endotracheal tube, the patient was rotated 180� away
from the anesthesia team. The surgical robotic cart was
positioned 30� from the surgical bed on the left side of the
patient. It is equipped with a robotic manipulator and four
mounted arms. However, we only used three of the robotic
arms: one arm held a 0� or 30� endoscope, and the other
two held 5-mm instruments. The vision cart is equipped
with 2 three-chip cameras mounted within one integrated
12-mm stereoscopic endoscope. This optical system creates
a wide-view high definition illusion of a 3D surgical field.
Its movable endoscope expands the surgical field by
changing viewing angles and position. The arms of the
EndoWrist� instruments (Intuitive Surgical Inc) have an
enhanced distal articulation design that provides flexion,
extension, pronation, and supination at the distal end of
instruments for finer tissue manipulation [3]. All proce-
dures were conducted using 5-mm EndoWrist� instruments
(a Maryland atraumatic forceps and an electrocautery
spatula tip). These instruments were introduced 30� later-
ally from the arm supporting the 0� endoscope and were
placed in the right or left arm of the robot, respectively,
1796 Eur Arch Otorhinolaryngol (2011) 268:1795–1801
123
depending on tumor localization and/or surgeon decision.
Places could be switched intraoperatively depending on the
surgeons’ preference.
The surgeon’s console was positioned away from the
patient, on his left side. The surgeon’s console displays a
three-dimensional view of the operative field by having a
separate monitor for the left and right eye views. At the
console, the surgeon controls the instrument arms and
camera by maneuvering the master robotic manipulators.
The assistant was seated at the head of the patient. The
video tower was on the right side of the patient.
Two cautery units were used: one electrocautery unit is
connected the arm fitted with the electrocautery spatula tip
and the second one is connected to a coagulating suction
tube handled by the second surgeon at the head of the
patient.
A table with suction tubes of various diameters, surgical
clips applier and various forceps used in TLM was placed
behind and to the left of the assistant (Fig. 1).
A double cheek retractor (Hager & Werken, Duisburg,
Germany) was used to protect the patient’s lips. Eye shields
were also used (EMS Medical Ltd, Gloucester, UK)
(Fig. 2). The Feyh-Kastenbauer (FK) retractor (Gyrus
ACMI, Southborough, MA) was used for most of the sur-
geries of laryngeal or pharyngeal tumors because it was,
until recently, the only one providing a good exposure of
the pharyngo-laryngeal region. A Crow-Davis retractor
was used for oral cavity tumors. A new retractor: the LARS
(Larynx advanced retractor system) retractor (Fentex,
Tuttlingen, Germany) designed by the senior authors (MR,
GL) was used in a small number of surgeries (Fig. 3). This
new retractor has several advantages. The framework
extends horizontally and makes the passage of the arms
through the mouth easier, there are easily adaptable and
removable vertical bars for the handling of instruments,
there are two screwing devices allowing the sliding
movement of the blade upward and downward as well as
backward and forward, finally the ratchet system can be
used starting from the beginning of the suspension process.
The retractor was suspended anteriorly with a Fentex
laryngoscope holder (Fentex, Tuttlingen, Germany).
For smoke aspiration in laryngeal and pharyngeal sur-
geries, a flexible aspiration tube, with continuous aspira-
tion, was introduced into the nasopharynx through the right
or left nostril and held in place with an adhesive tape.
Tumor resection followed the principles of the European
Laryngological Society for supraglottic tumors [13]. For
tonsil, base of tongue and hypopharyngeal tumors, the
techniques used were similar to those described by Wein-
stein et al. [10] for transoral robotic radical tonsillectomy,
Moore et al. [11] for base of tongue tumors and Park et al.
[9] for hypopharyngeal tumors.
Fig. 1 Surgical setting. 1 Da
Vinci robot 2 1st surgeon at the
console 3 2nd surgeon at the
patient’s head 4 Nurse at the
instruments table 5 2nd table for
Da Vinci robot devices 6 Rack
for imaging equipement
7 Anesthetist 8 Monopolar/
bipolar cautery
Eur Arch Otorhinolaryngol (2011) 268:1795–1801 1797
123
En bloc resection was always possible in this series.
Hemostasis was achieved using the suction-coagulation or
the surgical clips.
The surgical specimen was oriented on a cork plate for
histological examination after formalin fixation. Additional
margins from the surgical bed were taken in regions close
to the tumor to investigate the adequacy of tumor removal
and sent for frozen section analysis. Despite the thermal
effect of the monocautery, margin assessment was always
possible.
After tumor resection, the surgical field was covered
with a thin film of fibrin glue (Tissucol� Baxter, Vienna,
Austria) after the verification of the absence of communi-
cation between surgical field and the neck.
Management of the neck
Patients with negative necks on clinical and radiological
examination were enrolled in the sentinel node study
ongoing in our institution [15]. If the sentinel node was
positive for tumor invasion, neck dissection was performed
in the next 3 weeks. For patients with positive clinical and/
or radiological necks, unilateral/bilateral modified radical
neck dissection was performed in the same operation time
unless a major communication between the primary tumor
field and the neck was anticipated (tumors of the lateral
pharyngeal wall). In these cases, neck dissection was per-
formed during the next 3 weeks.
Postoperative care
No systematic tracheostomy was performed, but all patients
with laryngeal or pharyngeal resections were monitored for
24 h in the intensive care unit. All patients had systematic
steroids for 72 h and inhaled steroids for 1 week.
Patients in whom swallowing difficulties were antici-
pated had a small nasogastric feeding tube inserted during
the surgery. All the patients had intensive swallowing
therapy starting on the following day of the surgery.
Depending on the final histological report of the prod-
ucts of the tumor resection and neck dissection, adjuvant
radiation therapy or chemo-radiation therapy was decided
after discussion of the patients’ file on the tumor board.
Adjuvant radiation therapy was prescribed if there was
evidence on neck dissection of: two or more lymph nodes
involved with metastatic tumor or perineural or angi-
olymphatic invasion at the primary site. Adjuvant chemo-
radiation treatment was prescribed if there was extracap-
sular spread of tumor metastasis in one or more lymph
nodes or evidence of margins positive for tumor at the
primary site (with no possibility of extended surgery
without impeding organ preservation).
Swallowing exercises, neck and shoulder physiotherapy
and dietary counseling were planned in the postoperative
period.
Oncologic patients at our institution are evaluated with a
complete physical examination by the primary head and neck
surgery team every month for 6 months then every 3 months
for 1 year, then every 6 months for 3 more years, and then
yearly. A contrast-enhanced PET/CT scan is planned yearly or
as necessary depending on clinical examination.
Numerical variables were expressed as mean ± stan-
dard deviations and compared by Wilcoxon rank sum test.
Correlations were assessed by Spearman rank coefficient.
All tests are two-tailed and were performed using SPSS
15.0 statistical software (SPSS Inc., Chicago, IL).
Results
Twenty-four patients (23 men and 1 woman) were included
in this study. The mean age was 62 years (range 43–78
years). Ten patients had supraglottic tumors (6 epiglottic
Fig. 2 Double cheek retractor (Hager & Werken, Duisburg, Ger-
many) and eye shields (EMS Medical Ltd, Gloucester, UK)
Fig. 3 LARS retractor (Fentex, Tuttlingen, Germany)
1798 Eur Arch Otorhinolaryngol (2011) 268:1795–1801
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tumors, 2 ventricular fold tumors, 2 aryepiglottic fold
tumors), 10 had pharyngeal tumors (2 piriform sinus
tumors, 5 tonsil tumors, 1 tongue base tumor, 2 pharyngeal
wall tumors) and 4 had oral cavity tumors (tongue tumors).
Most of the patients had early tumors: 9 patients had T1
tumors, 12 had T2 tumors, and 1 patient had a T3 tonsil tumor.
The types or surgeries performed are as follows: 10
transoral robotic supraglottic laryngectomies, 5 transoral
robotic radical tonsillectomies, 4 transoral robotic partial
glossectomies, 5 transoral robotic partial pharyngectomies.
In all cases, negative resection margins were achieved
on frozen section analysis, and confirmed with routine
histological examination. None of them received intraop-
erative reconstruction.
Thirteen patients had N0 clinical and radiological necks,
5 were N1, 2 were N2a, 2 were N2b, 1 was N2c and 1 was
N3. After neck exploration with the sentinel node tech-
nique and neck dissection when indicated: 8 patients were
pN0, 7 patients were pN1, 7 patients were pN2 and 2 were
pN3.
None of the patients required tracheotomy and there
were no intraoperative complications related to the use of
the robot. However, we observed three complications in
this series: tongue edema, delirium tremens, cardiac
infarcts. Tongue edema may be due to the pressure on the
tongue by the FK retractor in a patient with a limited mouth
opening and a long duration of surgery.
We used the FK retractor in 18 procedures, the Crow-
Davis retractor for 2 procedures and LARS retractor in 4
procedures.
The mean follow-up time is 17 months. This period is
insufficient for adequate oncologic control data for com-
parison with other treatments. There were two disease-
related deaths because of locoregional recurrence of tumors
of the base of tongue for one patient and mobile tongue for the
other patient. Both had neck dissection at the time of surgery
followed by radiation therapy because of extracapsular
spread. No concomitant chemo-radiation therapy could be
performed in both of the patients because of comorbidities
precluding the administration of chemotherapy.
Time parameters assessed
The time required to complete two discrete stages of the
operation was carefully documented. These stages are: the
installation of the mouth retractor to achieve adequate
exposure and the operative procedure.
Exposure of the surgical field
The mean time required for installation of the mouth
retractor to achieve adequate exposure of the surgical field
was 24 ± 14 min, with a range of 10–60 min.
Duration of the operative segment
The mean overall surgical time was 67 ± 46 min with a
range of 12–180 min.
Overall procedure time
Overall, the mean cumulative time for adequate surgical
field exposure and the operative segment for all operations
was 92 ± 56 min with a range of 22–230 min. Sometimes
the exposure of the tumor took nearly as much time as
removal for the tumor. We also recorded the overall pro-
cedure time for each type of surgery according to the date
of the procedure on the learning curve. The mean total
operative time was 122 ± 63 min for supraglottic laryn-
gectomies, 78 ± 55 min for tonsillectomies, 71 ± 37 min
for partial pharyngectomies and 58 ± 66 min for resection
of oral cavity tumors. For all the procedures, there was a
significant reduction of both the operative segment and the
overall procedure time between the first group of treated
patients (n, 1–12) and the second group of treated patients
(n, 13–24). For the operative segment, time was reduced
from 88 ± 53 to 47 ± 29 min (p = 0.020). For the overall
procedure, time was reduced from 117 ± 64 to 66 ± 33
min (p = 0.014). Moreover, there was a significant corre-
lation between the sequential order of the procedure and
the operative segment time (r = -0572, p = 0.003) or the
overall procedure time (r = -0.590, p = 0.002). How-
ever, the time taken for exposure was not reduced with
experience (Fig. 4).
The mean hospital stay was 9 days (2–50 days). Oral
feeding was resumed at 3 days (1–20 days) under speech
therapy control.
Discussion
The da Vinci system provides some advantages in com-
parison to TLM. It filters out natural hand tremor, adjusts
the large hand movements of the operator to the small
movements of instruments in the airway enhancing dex-
terity and finally it allows a three-dimensional visualization
of the surgical field which gives the surgeon true depth
perception [4]. Taking advantage of these characteristics,
many surgeons are performing transorally, surgeries
that were still performed with an open approach, such
as resection base of tongue of cancer, or supraglottic
laryngectomies, or resection of hypopharyngeal tumors
[5, 8–11].
We did not encounter technical difficulties during the
procedure because all the patients underwent previous
endoscopy under general anesthesia to verify the adequate
exposure with the appropriate retractor. This safe attitude
Eur Arch Otorhinolaryngol (2011) 268:1795–1801 1799
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precluded the necessity to unexpectedly convert a TORS to
an open approach. The first procedures were performed by
the two senior surgeons. At present, one of the senior
surgeon is at the console with one of our fellows or senior
residents as the helping hand. Starting the procedures with
two experimented surgeons is advised. The surgeon at the
head of the patient has an important role for the safety of
the procedure.
If we compare our results to those published in the lit-
erature, we find that the mean total time of transoral robotic
supraglottic laryngectomy in our series (122 min) is com-
parable to the total operating time ranging between 92 and
178 min in the first three patients with supraglottic partial
laryngectomy in the series by Weinstein et al. [5].
For tumor of the tonsils, our mean total operating time
for radical tonsillectomy was 78 min which is concordant
with the findings of Weinstein et al. in a prospective study
on 27 patients undergoing transoral robotic radical tonsil-
lectomy, where the mean overall operative time was 1 h
and 43 min (range 26 min to 3 h 53 min) [10].
For transoral robotic partial pharyngectomy, our mean
operative time of 71 min is concordant with the durations
reported by Park et al. [9].
Despite our new application of TORS, we did not find
any preoperative complications and the use of frozen sec-
tion analysis allowed negative surgical margins for all
patients in a single procedure. Two patients had local
recurrences. Both had T2 tumors, one of the base of tongue
and the other of the mobile tongue. They had negative
margins on frozen section analysis that were confirmed on
routine histological examination. These recurrences can be
due to the absence of the administration of chemotherapy
because of the patients’ co morbidities especially that these
tumors can be multifocal.
For all the procedure, there was a significant reduction
of both the operative segment and the overall surgical time
with improving skills. When we separate the patients into
two groups, the first composed of the first 12 patients and
the second by the 12 last patients, the duration of the
operative segment was reduced by half going from 88 to
46 min. In their study, Moore et al. [11] found that a
reduction in exposure time did not find a reduction of the
operative time as we did. This might be due to the inclusion
of advanced T stages in their series, which are known to
necessitate longer operative time.
Despite all its benefits, there are some limitations
encountered in TORS [16]:
1. Interference of the surgical arms with one another,
with the camera arm, or with the retractor during the
operation.
2. Thermal effects with monocautery leading to more
crusting.
3. Lack of tactile feedback recognition and proprioception.
4. The absence of integrated aspiration.
Solutions might be found.
The interference of the surgical arms with one another
and with the camera arm is due to the narrow operative
area and to the large size of the surgical arms. It sometimes
requires manual repositioning of the robotic instruments
and the camera. A slight increase in the distance between
the camera port and the instrument port might result in the
reduction in the frequency of the interference. The use of
the appropriate retractor is also of primary importance to
enlarge the operative view. Hockstein and colleagues [17]
reported the use of the Dingman mouth gag for airway
surgery on a mannequin and cadavers. The Dingman mouth
gag with cheek retractors achieved satisfactory exposure,
unimpeded instrument movement, precise handling of tis-
sue, and an ability to perform endolaryngeal suturing.
Weinstein et al. [5] reported the use of the FK retractor for
supraglottic partial laryngectomy and Crow-Davis mouth
gag for radical tonsillectomy [10]. Park et al. [9] used the
FK retractor for hypopharyngeal tumors.
We find that the use of the FK retractor with an addi-
tional cheek protector is valuable. However, in some cases,
the surgical exposure proved to be difficult [18], even with
the FK retractor, this is why a new retractor was introduced
by the authors.
The thermal effects of the monocautery will be reduced
in the future by the use of the CO2 laser wave guide.
Tactile feedback is considered very valuable in surgery;
however, the three-dimensional images with the da Vinci
system compensate for the diminished tactile information.
There is also a visual adaptation.
The current da Vinci robot lacks an integrated suction
device. To resolve this problem, Weinstein et al. [5]
attached an endotracheal suction to a robotic arm. Suc-
tioning might be done through a flexible nasopharyngeal
Fig. 4 Operative segment and overall procedure time depending on
the sequential order of the surgical procedure in the learning curve (y-axis time in minutes, x-axis rank of surgery during the learning curve)
1800 Eur Arch Otorhinolaryngol (2011) 268:1795–1801
123
tube and if additional suctioning is needed, it might be
provided by a rigid suction tube handled by the assistant or
fixed on the framework of the LARS retractor.
Conclusion
TORS is feasible, safe, oncologically and functionally
efficacious. It has a short learning curve for surgeons
already trained in transoral surgery. It facilitates the
exposure of surgical sites like the supraglottis, the base of
tongue and the piriform sinuses. It is a valuable technique,
and we are convinced that it will have many applications in
the future in the field of head and neck surgery.
The new LARS retractor and the CO2 wave guide are
new contributions to TORS and provide solutions to lim-
iting factors for the application of TORS in some transoral
procedures.
Acknowledgments The authors would like to thank Mrs M.-B.
Jacqmain for the illustrations.
Conflict of interest None.
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