Content uploaded by Peter Barton-Smith
Author content
All content in this area was uploaded by Peter Barton-Smith
Content may be subject to copyright.
ORIGINAL ARTICLE
A pilot study of robotic uterine and vaginal vault manipulation:
the ViKY Uterine Positioner
TM
Nikolaos Akrivos •Peter Barton-Smith
Received: 30 March 2013 / Accepted: 11 April 2013
ÓSpringer-Verlag London 2013
Abstract A pilot study of uterine and vaginal vault
manipulation using a new surgical robot—The ViKY
Uterine Positioner
TM
––enrolled 36 cases comprising 31
hysterectomies, two myomectomies, two sacrocolpopexies
and one excision of severe endometriosis performed
between July 2010 and February 2012 in a tertiary referral
District General Hospital in the UK. Mean age was
48 years, body mass index 25.7 kg/m
2
and uterine weight
231 g. Nine cases were foot-controlled and 27 by Blue-
tooth voice control. ViKY UP
TM
docking time once
V-Care
TM
was inserted was 4.3 min. The device caused no
peri-operative complications. Adequate mobilization,
visualization and range of movement was possible in 81, 78
and 61 % of cases, respectively, with most of the problems
arising in cases with uterine weight [350 g. ViKY UP
TM
was detached and an assistant was required in three cases,
whilst V-Care
TM
came out of the uterus in one case. The
learning curve led to various adjustments including opti-
mizing patient position, increasing the device range of
movement and adjusting device sensitivity. As a result,
problems were minimized in our last nine cases. Adding
robotic uterine manipulation is the obvious next step to
give the gynecologist the ultimate control and stability of
the uterus during robotic-assisted surgery without having to
lift their head from the viewfinder or rely on a remotely
situated perineal assistant. ViKY UP
TM
is the first device to
deliver this. Pilot study results did not demonstrate com-
promised safety, and the device appears to be effective and
easy to learn.
Keywords Uterine manipulation ViKY UP
Minimally invasive
Introduction
During an open abdominal hysterectomy, clamps are
placed on the uterine cornua, allowing easy manipulation
of the uterus. However, the development of conventional
laparoscopy and robotic surgery has required new tech-
niques for manipulating the uterus. Usually, a uterine
manipulator is placed vaginally and controlled by an
assistant during the procedure. Robotic-assisted gyneco-
logical surgery is increasing rapidly particularly in the
USA [1] and, as with any minimally invasive surgery
technique, efficient and safe manipulation of the uterus is
extremely important. The main current technique requires
manual repositioning of the uterus by the perineal assistant,
who may not be able to efficiently respond to commands or
hold the uterus stable due to inexperience, lack of coordi-
nation, poor commands by the surgeon or even tiredness
and boredom. Furthermore, the presence of a perineal
assistant necessitates extra operating room staff and space.
In robotics these problems are compounded by more dif-
ficult communication since the surgeon is remote from the
bedside with no direct visualization of the perineal or
bedside assistant’s maneuvers. These issues have been
partly overcome by fixed platforms which attach to the bed
or nearby and which hold the main uterine manipulator in a
fixed position and can be easily adjusted manually [2].
This work was presented as an invited presentation at The World
Robotic Gynecology Congress and the ISGE Annual Meeting in
Orlando, FL, USA in March 2012.
N. Akrivos (&)P. Barton-Smith
Department of Gynecology, Royal Surrey County Hospital,
Egerton Road, Guildford GU2 7XX, UK
e-mail: nakrivos@hotmail.com
P. Barton-Smith
e-mail: p.barton-smith@surrey.ac.uk
123
J Robotic Surg
DOI 10.1007/s11701-013-0406-3
Author's personal copy
However, the optimum situation would be for the console
surgeon to be in full control of uterine positioning and
maintaining uterine stability. The solution needs to allow
the surgeon accurate, effective and secure movement,
whilst not having to lift their head from the viewfinder, or
move their feet from the console pedals to operate an
additional foot pedal. The ViKY Uterine Positioner
TM
(EndoControl Medical, La Tronche, France) is a new
device that provides uterine manipulation through a robotic
arm remotely controlled by the console surgeon to achieve
the aims outlined above. The ViKY UP
TM
device was
initially designed as a compact motorized laparoscope
holder for conventional laparoscopic surgery controlled by
either foot pedal or voice activation. It received FDA
approval as a laparoscopic camera manipulator in
December 2008 and since that time has been used to
facilitate minimally invasive surgery in many specialties.
The same technology can now be applied to uterine
manipulation in robotic-assisted hysterectomies and other
gynecological surgeries that require displacement of the
uterus out of the anatomical location to optimize the view
of the operating surgeon.
Materials and methods
Data were included for 36 women who underwent non-
consecutive routine benign gynecological surgery at The
Royal Surrey County Hospital, Guildford, Surrey, UK
between July 2010 and February 2012. The clinic is a
tertiary referral clinic for complex benign gynecology set
in a District General Hospital in the UK. Initially a sample
size of 20 cases was selected but various technique modi-
fications in the pilot study led to a final ‘‘steady state’’
technique at 36 cases.
There were no specific inclusion or exclusion criteria
and all patients undergoing routine benign surgery requir-
ing uterine manipulation were eligible. The majority of
cases were hysterectomy cases as these were specifically
required for an FDA approval study that was being carried
out simultaneously.
Initially a V-Care
TM
manipulator is placed as normal in
the uterus. Following this, a reusable arm bracket is con-
nected to the right side of the operating table to which the
ViKY UP
TM
robot is attached, giving it a stable platform
close to the perineum. ViKY UP
TM
is then attached to
V-Care
TM
by a simple connecting adaptor (Fig. 1).
All of the surgeries were performed by a single expe-
rienced gynecological robotic surgeon using the da Vin-
ci
TM
S HD robotic system. Two different sizes of ViKY
UP
TM
ring were used, the small initially and the medium in
all subsequent cases (Fig. 2). Manipulation of the uterus
was achieved by either by a foot control console placed
adjacent to the main robotic console or by Bluetooth
TM
voice control using a single ear transmitter/receiver worn
by the console surgeon, thereby allowing uterine manipu-
lation without lifting the head from the console. In the case
of vault manipulation for sacrocolpopexy, the tip of the
V-Care
TM
was removed so that manipulation was achieved
by movement of the colpotomizer component of the
V-Care
TM
. Initially the console surgeon performs a once-
only recording of their voice profile to allow effective
voice recognition for all subsequent cases, though during
the study two upgrades of the voice recognition software
were implemented.
The system allows the console surgeon to move the
uterus in individual movements up and down, in and out,
left and right. Furthermore, up to three saved positions can
be recorded to allow easy return of the manipulator to
specific points chosen by the surgeon. After setting up and
adjusting the ViKY UP
TM
, the uterus can be repositioned
by pressing a foot pedal or simple verbal commands
without the need for a perineal assistant. Safety is ensured
by a surgeon-initiated ‘‘stop’’ override voice command or
foot-switch ‘‘stop’’ override, and by an inbuilt override that
stops the device if any external pressure is felt on the
device due to contact with the patient or any other sur-
rounding objects.
The object of this study was to prospectively collect data
in a pilot observational case series to demonstrate the
safety and effectiveness of ViKY UP
TM
for uterine or
vaginal vault manipulation during robotic-assisted gyne-
cological surgery.
Data were recorded immediately after surgery on a
written data sheet in the operating theatre. Demographic
data included age, body mass index (BMI), weight of
uterus or myomas extracted, uterine sound length and
parity. Intra-operative data included: the time to connect
Viky UP
TM
to the V-Care
TM
manipulator, skin-to-skin
operating time, inadvertent detachments of ViKY UP
TM
and the need to resort to a perineal assistant. Subjective
data were collected for the surgeon’s perception of the
effectiveness of visualization, mobility, range of movement
and voice control responsiveness. Intra-operative compli-
cation data were collected for uterine perforation, vaginal
and cervical lacerations, excessive bleeding or blood
transfusion and injury to bladder or bowel.
ViKY UP
TM
is a CE-marked product (June 2010) and
therefore this study is considered to be a Post Market
Surveillance study (non-interventional) and classifies as a
service evaluation not requiring ethical review in the UK.
This study did not incur any extra cost to the department.
For statistical analysis all data were entered into
Excel
TM
and analyzed using simple descriptive statistics
looking for and taking into account unexpected outliers in
the analysis.
J Robotic Surg
123
Author's personal copy
Results
The 36 cases comprised 31 hysterectomies, two myomec-
tomies, two sacrocolpopexies for vaginal vault prolapse
and one severe endometriosis excision. Mean age, BMI and
uterine weight were 48 years, 25.7 kg/m
2
and 231 g (ran-
ges 29–64, 21–39.4 and 64–1,732, respectively).
In 27 cases, ViKY UP
TM
was voice-controlled and in
nine foot-controlled. Adequate visualization, mobiliza-
tion and range of movements were possible in 81, 78
and 61 % of cases, with most of the problems arising in
uteri heavier than 350 g. No response problems were
encountered in the foot-controlled cases, whilst in 2
out of the 27 voice-controlled cases the ViKY
UP
TM
occasionally failed to respond to first request.
However, repetition of the command resulted in correct
function.
The mean time taken to attach ViKY UP
TM
to the
V-Care manipulator was 4.3 min (range 1–32). The mean
procedure (skin to skin) duration was 142 min (range
50–232). ViKY UP
TM
became detached, meaning a peri-
neal assistant was required, in three cases (8 %), whilst the
V-Care
TM
came out of the uterine cavity in one case.
Pneumoperitoneum was well maintained in all cases and
there was good delineation of the vaginal fornixes.
No intra-operative complications were observed for
uterine perforation, vaginal laceration, cervical tear, or
bladder, ureteric or bowel injury in any of the cases. In
addition, no cases required blood transfusion and there
were no conversions to open surgery.
Fig. 1 ViKY UP
TM
set-up
Fig. 2 ViKY UP
TM
ring
J Robotic Surg
123
Author's personal copy
Discussion
In our experience the use of a uterine manipulator, whether
it be by perineal assistant, a fixed hydraulic platform or
surgical robot, makes most benign gynecological mini-
mally invasive procedures easier. The use of the third
robotic arm can also give a measure of uterine manipula-
tion but the combination of both uterine and third arm
manipulation really optimizes the ability to get the best
surgical view. The third arm can also be freed up for
helping with fine anatomical dissection and not just as a
general retractor. Uterine manipulation also allows the
uterus to be pushed into the patient more easily and con-
sequently the ureters are displaced anatomically further
from the uterine pedicles where they are otherwise at risk
of compromise during hysterectomy.
Demographically, the women in our study have a rela-
tively low mean BMI of 25.7, in comparison with that
which might be seen in some other countries like the USA
[3]. We did operate on women with a BMI up to 39.4 and
did not find that increased BMI was a problem in terms of
mobility or range of movement of the device due to direct
conflict with the larger thighs of high-BMI women. Our
technique evolved to ensure that thighs were abducted as
much as possible to create as flat a surface as possible for
placing the ViKY UP
TM
ring against the perineum and this
also had the effect of widening the distance between the
thighs and avoiding instrument conflict.
The mean uterine weight of 231 g (and one case of
1,732 g) shows that we were operating on significantly
enlarged uteri and stretching the capability of the device to
its limit. It did become apparent in the early stages, how-
ever, that uteri of [350 g had reduced range of movement
and visualization. This in some ways is purely an inherent
property of the large uterus itself, and not a reflection on
the device’s reduced ability to deal with the large uterus.
However, the safety software in the device means that it
will not torque the uterus as much into the patients’ thighs
as a perineal assistant would, and this results in a reduction
in range of movement compared to what is achievable by a
hand-held manipulator. That being said, uteri up to
approximately 350 g posed no range of movement or
visualization problems whatsoever.
Several strategies were implemented to overcome the
large uteri issue, including switching to the larger medium-
sized ring instead of the extra-small version to improve the
inherent range of movement of the device. To accommo-
date the larger ring at the perineum, thigh abduction has to
be maximized as described above. The sensitivity of the
software’s recognition of external contact with the patient
was also decreased so that range of movement was also
improved by safely allowing more torque of the device
against the patient at the extremes of manipulation.
Furthermore, no device detachments occurred in the latter
part of the series with these adjustments and subjectively
there were no range of movement, mobility or visualization
issues in the final nine cases. From a safety perspective, the
ViKY UP
TM
performed well, as we experienced no intra-
operative complications caused by the device throughout
the whole pilot study.
The upgrade to third-generation voice recognition software
improved responsiveness. There are still some tips and tricks
that need to be observed with voice control, including the
need to remember to pause before giving a command or else
the system does not respond, and to adjust the voice control
sensitivity scale to allow optimum response depending on the
natural assertiveness of the surgeon’s voice.
Further consideration is currently being given to
attaching ViKY UP
TM
to alternative manipulators. A new
adaptor connecting to the Advincula Arch
TM
by Cooper
Surgical
TM
is currently being trialed to see if this improves
range of movement with large uteri.
In terms of set-up, the learning curve is fast and ViKY
UP
TM
docking time does not add more than a mean of
4.3 min to the operating time. It is easy and intuitive to use
and assemble. Since modifying the technique, we have
found the ViKY UP
TM
to be an important addition to our
surgery. Da Vinci
TM
surgery gives improved view, preci-
sion and ergonomics and it seems the logical next step to
include stable, surgeon-controlled uterine manipulation to
the package to improve the surgeon’s rhythm and view and
to remove the problem of communication with a perineal
assistant. In addition, as the ViKY UP
TM
can also be used
as a laparoscopic camera holder, it has more than one role
in the department, making it more cost-effective. The cost
of the device in the USA will be about US$75,000. Cost
data were not collected to assess potential savings resulting
from not requiring a perineal assistant.
This pilot study does have some limitations. The fact
that cases were not consecutive must introduce an element
of selection bias into the results. Cases were more likely to
take place when EndoControl staff were present or when
the case was not a teaching or demonstration case. A
randomized controlled trial is required with multiple sur-
geons comparing the use of ViKY to a control group with a
perineal assistant. Operating times, peri-operative out-
comes and cost data could be compared.
Conclusion
ViKY UP
TM
is the first attempt at extending the role of
surgical robots to uterine manipulation, which is one of the
most crucial components of gynecological minimally
invasive surgery. As with any new technology, there is a
learning curve that has been more pronounced for us in this
J Robotic Surg
123
Author's personal copy
pilot study than for surgeons who will subsequently use the
system. Our initial experience with the ViKY UP
TM
has
been very encouraging. It does not appear to compromise
patient safety, leads to a more fluid surgical experience for
the robotic surgeon, and is the inevitable next step in the
development of gynecological robotics.
Acknowledgments The work was carried out with educational
grant funding from the manufacturer of ViKY UP
TM
, EndoControl
TM
,
La Tronche, France and an honorarium was paid to the surgeon by
Mantis, UK
TM
.
Conflict of interest None.
References
1. Gobern JM, Novak CM, Lockrow EG (2011) Survey of robotic
surgery training in obstetrics and gynecology residency. J Minim
Invasive Gynecol 18(6):755–760
2. Swan K, Kim J, Advincula AP (2010) Advanced uterine manip-
ulation technologies. Surg Technol Int 20:215–220
3. Nawfal AK, Orady M, Eisenstein D et al (2011) Effect of body
mass index on robotic-assisted total laparoscopic hysterectomy.
J Minim Invasive Gynecol 18(3):328–332
J Robotic Surg
123
Author's personal copy
