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J Robotic Surg (2015) 9:179186

DOI 10.1007/s11701-015-0513-4

ORIGINAL ARTICLE

Virtual reality robotic surgery simulation curriculum to teach


robotic suturing: a randomized controlled trial
Daniel J. Kiely1,2 Walter H. Gotlieb3 Susie Lau3 Xing Zeng4 Vanessa Samouelian2

Agnihotram V. Ramanakumar5 Helena Zakrzewski1 Sonya Brin3


Shannon A. Fraser6 Pira Korsieporn7 Laura Drudi8 Joshua Z. Press9

Received: 6 March 2015 / Accepted: 28 April 2015 / Published online: 16 May 2015
Springer-Verlag London 2015

Abstract The objective of this randomized, controlled sutured for 10 min using the da Vinci Surgical System.
trial was to assess whether voluntary participation in a Performances were videotaped, anonymized, and subse-
proctored, proficiency-based, virtual reality robotic sutur- quently graded independently by three robotic surgeons. 27
ing curriculum using the da Vinci Skills SimulatorTM participants were randomized. 23 of the 27 completed both
improves robotic suturing performance. Residents and at- the pre- and post-test, 13 in the training group and 10 in the
tending surgeons were randomized to participation or non- control group. Mean training time in the intervention group
participation during a 5 week training curriculum. Robotic was 238 136 min (SD) over the 5 weeks. The primary
suturing skills were evaluated before and after training outcome (improvement in GOALS? score) and the sec-
using an inanimate vaginal cuff model, which participants ondary outcomes (improvement in GEARS, total knots,
satisfactory knots, and the virtual reality suture sponge 1
task) were significantly greater in the training group than
This manuscript was presented at the Society of Gynecologic
the control group in unadjusted analysis. After adjusting for
Oncology 45th Annual Meeting on Womens Cancer, Tampa, FL,
USA, March 23, 2014 and at the Society of Gynecologic Oncology of lower baseline scores in the training group, improvement in
Canada 35th Annual General Meeting. June 13, 2014. Niagara Falls, the suture sponge 1 task remained significantly greater in
ON, Canada. the training group and a trend was demonstrated to greater
improvement in the training group for the GOALS? score,
Condensation: In this randomized controlled trial, learners
randomized to participation in a virtual reality robotic suturing GEARS score, total knots, and satisfactory knots.
curriculum showed a trend towards greater improvement when scored
on their ability to suture an inanimate vaginal cuff model using the da Keywords Randomized controlled trial  Patient
Vinci Surgical System. simulation  Computer simulation  Graduate medical
ClinicalTrials.gov: NCT01811095, www.clinicaltrials.gov. education  Robotics  Operative surgical procedures

Electronic supplementary material The online version of this


article (doi:10.1007/s11701-015-0513-4) contains supplementary
material, which is available to authorized users.
5
& Daniel J. Kiely Epidemiology, McGill University, Montreal, Canada
danieljameskiely@gmail.com 6
General Surgery, Jewish General Hospital, McGill
1
University, Montreal, Canada
Experimental Surgery, McGill University, Montreal, Canada 7
2
Obstetrics and Gynecology, McGill University, Montreal,
Gynecologic Oncology, University of Montreal, Montreal, Canada
Canada 8
3
Vascular Surgery, McGill University, Montreal, Canada
Gynecologic Oncology, Jewish General Hospital, McGill 9
University, Montreal, Canada Division of Oncology and Pelvic Surgery, Pacific
4
Gynecology Specialists, Seattle, USA
Gynecologic Oncology, Royal Victoria Hospital, McGill
University, Montreal, Canada

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180 J Robotic Surg (2015) 9:179186

Introduction technical skills or global rating scales [11]. There was a


strong trend to higher pass rate on the global rating scale in
Robotic suturing is an important skill for the aspiring the training group [11].
robotic surgeon, which must be performed with precision Our study aimed to contribute further to this literature
and efficiency. Robotic suturing skills may possibly be by evaluating type 2 training validity of the da Vinci
developed outside of the operating room through surgical Skills SimulatorTM where the outcome was ability to suture
simulation. Interest in simulation is on the rise due to an inanimate model of the vaginal cuff. Our intervention
several current trends including increasing emphasis on was a focused, proficiency-based, virtual reality robotic
patient safety and operating room efficiency, increasing suturing curriculum. We chose a proficiency-based cur-
complexity of surgery, decreased trainee work hours, and riculum because this allows tailoring the amount of
greater medico-legal risk [1, 2]. simulation training required per trainee to achieve a pre-set
Multiple studies have demonstrated the face, content, goal for skill. Increasingly, proficiency-based curriculums
construct, and concurrent validity of the da Vinci Skills are being recognized as the gold standard in the simulation
simulator [37]. Predictive validity refers whether perfor- literature [1217].
mance with the simulator can predict future performance of
the task in reality or in another simulation, with or without
intervening training [8, 9]. An additional form of validity Materials and methods
merits definition: training validity. Training validity refers
to the extent to which training with the simulator improves Ethics and eligibility criteria
ability to perform a task. This may be considered a subset
of predictive validity which explicitly requires training Ethics approval was obtained from the McGill Faculty of
between baseline and final assessment. Training validity Medicine Institutional Review Board. Residents or at-
has three basic subtypes, depending on outcome: type 1, tending surgeons in the department of Obstetrics and
the outcome is the same simulation task used for training; Gynecology, Urology, General Surgery, or Cardiac Surgery
type 2, the outcome is a different simulation, ideally one were eligible. The study was conducted in the spring of
which is considered more realistic; and type 3, the outcome 2013. Funding was obtained from the Jewish General
is the actual real-life task which is the goal of training. To Hospital, Department of Gynecologic Oncology Research
our knowledge, there are no studies published to date Fund and by a Masters Award from the Canadian Insti-
assessing the strongest type of training validity for robotic tutes of Health Research.
surgery, type 3. Hung et al. [10] studied type 2 training
validity for the da Vinci Skills SimulatorTM where the
outcome was ability to operate using the actual da Vinci Randomization
robot on models constructed from ex vivo animal tissue in
three exercises: partial nephrectomy, cystotomy and cys- A random sequence for 40 participants was generated by an
totomy repair, and bowel resection. The training group associate not otherwise involved in the study using an
performed ten weekly training sessions with each session online random number generator with randomly permuted
including the completion of 17 pre-selected virtual reality blocks of 4 or 6 with a 1:1 ratio of training group to control
exercises using the da Vinci Skills SimulatorTM [10]. group within each block. The associate then wrote the
Although the training group did not show significantly group allocation (train or control) on an index card, cov-
greater scores for final performance on the ex vivo animal ered the card with carbon copy paper, and sealed both in a
tissue exercises than the control group, greater performance sequentially numbered, opaque envelope to ensure alloca-
was achieved by the subset of participants who started with tion concealment [18]. Randomization occurred just prior
scores in the lower 50th percentile [10]. Similarly, Vaccaro to the first pre-test of the study.
et al. performed a randomized controlled trial assessing the
effect of virtual reality training (9 exercises, completed to Pre- and post-test
proficiency or at least 10 attempts) on ability to perform an
inanimate task involving incising and suturing chicken Ability to perform robotic suturing was evaluated using an
breasts (again, type 2 training validity) [11]. Both control inanimate vaginal cuff model, with assessments done at
and intervention groups improved, but the only statistically baseline and then 5 weeks later after completing the
significant difference between groups was in the time to simulation curriculum (or continuing with routine clinical
incision [11]. There were no significant differences in total duties). The study pre-test session included the following:
time, suturing time, objective structured assessment of (1) a 10 min robotic suturing task involving suturing an

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J Robotic Surg (2015) 9:179186 181

Fig. 1 The da Vinci Surgical System set-up with training arms and the inanimate vaginal cuff model

inanimate model with the actual da Vinci Surgical System achieve the completed score (equivalent to attaining all
and (2) completion of the suture sponge 1 task using the da component scores C60 % and overall score green
Vinci Skills SimulatorTM. For suturing the inanimate checkmark) non-consecutively on 2 occasions for the
model, we used the model of the vaginal cuff described by following tasks: camera targeting 1, camera targeting 2,
Finan [19], constructed from a beer huggie to represent suture sponge 1, suture sponge 2, suture sponge 3 and to
the vaginal cuff, a block of wood for positioning, and complete the horizontal suturing defect (HSD) task ten
balloons to represent the bladder and rectum, and to distend times. Participants in the training group set their own hours
the vaginal cuff. Prior to the pre-test, participants were for training. Given the voluntary nature of the study, there
given a verbal overview of how to use the da Vinci sur- was no obligation to train and participants were free to try
gical system. They were then instructed to suture closed the other simulation exercises outside the curriculum, although
vaginal cuff model using figure of eight stitches with participants were made aware of, and encouraged to
square knots composed of a double throw and then three achieve all the goals of the proficiency curriculum. Par-
single throws. This task was recorded using the camera of ticipants were informed that, on average, it was estimated
the da Vinci Surgical System. The post-test was identical that it would take 5 h to attain all the goals of the profi-
to the pre-test. The vaginal cuff model along with the set- ciency curriculum and that the suggested training schedule
up used on the testing day is shown in Fig. 1. Supple- was 1 h per week for 5 weeks. The study coordinator (DK),
mentary file 1 shows a demonstration of the task of su- at the time experienced in robotic virtual reality simulation
turing the vaginal cuff model. but not actual robotic surgery, was present for all training
sessions and offered suggestions for improvement.
Training intervention
Outcomes
The training group was assigned to a proficiency-based
robotic surgery simulation curriculum which took place The primary outcome was skill in performing the task of
over a 5 week period between pre- and post-test sessions, suturing the vaginal cuff model. This was assessed by three
and was completed in addition to usual clinical duties or blinded raters (two gynecologic oncologists and one gyne-
residency training. We used the da Vinci Skills Simulator cologic oncology fellow, all experienced in robotic surgery)
tasks and the goals of the training curriculum were to using the GOALS? score. This score is composed of the five

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182 J Robotic Surg (2015) 9:179186

domains of the GOALS score developed for assessing skill in Assessed for eligibility
laparoscopy which include autonomy, efficiency, tissue (n = 30)

handling, depth perception, and bimanual dexterity [20] plus


Excluded (n = 3)
two additional metrics developed specifically for robotics,
Not meeting inclusion criteria
precision and awareness of camera and instruments [10]. To (n = 1)
blind evaluators, all videos were coded and then rearranged Lost to follow-up
(n = 2)
in random order using a random number generator by a
member of the study team not involved in evaluations.
Scoring of the videos began only after completion of all
testing. Prior to scoring, the study coordinator explained the Randomized (n = 27)

domains of the GOALS? score to the evaluators and en-


couraged them to try to use the entire range of available Allocated to Allocated to control
intervention (n = 14) (n = 13)
scores from 1 to 5, as appropriate. Although we were not
aware of the GEARS score when designing our trial, the Completed pre-test (n=13) No da Vinci Skills Simulator

Allocation
training (n=12)
GOALS? includes 7 domains, 6 of which form the GEARS Participated in proficiency-
based curriculum but did not Engaged in some training
score [21]. Thus, our data allowed us to calculate the GEARS achieve all goals (n = 8) with da Vinci Skills Simulator
outside of study (n=1)
score as a secondary outcome of the study. Completed proficiency-based
The secondary outcomes were the number total knots and curriculum (n = 5)

satisfactory knots performed during the inanimate model


suturing task and scores in the virtual reality suture sponge 1 Lost to follow up Lost to follow up (n = 3)
simulator task on the pre-test and post-test dates. For scoring Follow up (n =0) (unable to attend post-
of total knots, if a knot was partially completed at the 10 min test)

stop time, it was scored as follows: 0.4, if the first double


throw was completed and cinched down and then, an addi-
tional 0.2 for each single throw cinched down. Satisfactory
knots were defined as knots that the rater would not cut out
Analyzed (n = 13) Analyzed (n = 10)
and re-suture during live surgery. The maximum score for
satisfactory knots was equal to the total knots score. If a Excluded from analysis:
(n = 1) (Absent from pre-
partial knot was judged satisfactory, the score for that partial test)
knot (e.g. 0.4) was retained as part of the satisfactory knot
score. Evaluators also assessed whether there was an injury Fig. 2 CONSORT diagram
to the bowel or bladder as assessed by perforation of the
balloons representing those structures. Following comple- testing date, regardless of whether the target sample size
tion of the post-test, participants from obstetrics and gyne- was obtained.
cology, as well as one gynecologic oncologist and one
gynecologic oncology fellow who also tried the task, were Statistical analysis
asked to complete a questionnaire assessing the realism (face
and content validity) of the inanimate vaginal cuff model as a Statistical analysis was conducted using SPSS. Ordinal
tool for learning robotic suturing. data (GOALS? score, GEARS score, and their compo-
nents) were analyzed using non-parametric tests (Wilcoxon
signed rank test for within group comparisons and Wil-
Sample size calculations coxon rank sum test for between group comparisons). The
GOALS? and GEARS score were treated as continuous
Sample size calculations for the trial were performed with data for multivariate regression. Continuous data (virtual
PASS 11 [22] using a non-parametric sample size calcu- reality simulator scores, total knots, and satisfactory knots)
lator assuming a mean improvement of scores and a stan- were analyzed using t tests.
dard deviation equal to 10 % of the maximum GOALS?
score in the training group versus no improvement in
scores in the control group, with a power of 0.08 and a Results
p value of 0.05 as the cut-off for statistical significance.
This calculation indicated the need for a sample size of 38, Our consort diagram is shown in Fig. 2. A total of 23 par-
with 19 participants in each group. Due to logistic con- ticipants contributed results for analysis based on attendance
straints, the trial was designed to stop after the pre-set final at both the pre- and post-test sessions, 13 in the training group

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J Robotic Surg (2015) 9:179186 183

Table 1 Baseline characteristics of the participants


Training group (n = 13) Control group (n = 10) p value

Training level 8 residents 9 residents Not


5 attendings 1 attendings applicable
Training level of residents 2 fourth year residents 1 fourth year resident Not
1 third year resident 6 third year residents applicable
3 second year residents 1 second year resident
2 first year residents 1 first year resident
Specialty 10 obstetrics and 5 obstetrics and Not
gynecology gynecology applicable
3 general surgery 3 general surgery
0 urology 2 urology
0 cardiac surgery 0 cardiac surgery
Mean age (range) 35 (2655) 30 (2734) 0.11
Mean number of robotics cases as primary console surgeon (range) 0 (0) 0 (0) 1.00
Mean number of robotics cases with some time on console (range) 0.7 (06) 1.2 (06) 0.97
Mean number of robotics cases as assistant (range) 0.8 (010) 3.3 (010) 0.12
Mean hours trained with laparoscopic simulators prior to study 11.3(080) 22.9 (160) 0.22
(range)
Mean hours trained with robotic simulators prior to study (range) 0.85 (03) 2.6 (020) 0.33
Mean baseline simulator score, suture sponge 1 (range) 49.0 (385) 74.5 (4494) 0.009
Mean baseline GOALS? score (range) 15.1 (7.3331.0) 21 (12.029.7) 0.020

and 10 in the control group. Table 1 shows the baseline score (p = 0.002), the GEARS score (p = 0.002), total
characteristics of the participants. Despite a rigorous ran- knots (p \ 0.001), satisfactory knots (p \ 0.001), and the
domization protocol, there were imbalances between groups suture sponge 1 score (p \ 0.001) (Table 2). The control
likely due to the small size of the trial and the lack of group also showed statistically significant improvements in
stratification by baseline scores. The training group, on av- the GEARS score (p = 0.041), total knots (p \ 0.001) and
erage, tended to be older, contained more attending physi- satisfactory knots (p = 0.004). Unadjusted analysis com-
cians, had less robotic surgery experience, less robotic paring the magnitude of the improvement in the training
simulation experience, and significantly lower pretest scores group to that of the control group showed statistically
for both the virtual reality simulator task (suture sponge 1) significantly greater improvement in the training group for
and the inanimate model task (GOALS? score). the GOALS? score, the GEARS score, total knots, satis-
The mean total time spent training with the da Vinci factory knots, and the suture sponge 1 score (Table 3).
Skills Simulator over the 5 week study period was 238 min At baseline, the training group had significantly lower
among the training group participants (range 15600 min). GOALS? scores (p = 0.020) and GEARS scores (p = 0.023)
Five of the 13 study participants achieved all the training than the control group. However, at the post-test, no statisti-
goals of the proficiency curriculum, with a mean time of cally significant differences were found between groups in the
272 min (range 175600 min). The three shortest training GOALS? scores (p = 0.455) or the GEARS scores
times were among participants who did not complete the (p = 0.598), suggesting that participation in the curriculum
curriculum. One participant in the control group performed allowed the training group to catch up to the control group.
approximately 3 h of robotic simulation training with the Training group participants with baseline GOALS?
da Vinci Skills SimulatorTM during the study period scores less than 14 out of 35 tended to have greater im-
outside of the study protocol. One participant in the provements (mean 8.5, n = 8) than those with scores
training group and two participants in the control group greater than 14 (mean 3.0, n = 5) with a p value of 0.067.
assisted at robotic surgery during the study period, in- A multivariate analysis was then conducted (Table 4),
cluding one participant in the control group who had the controlling for baseline scores with a regression model
opportunity to suture the vaginal cuff in live surgery twice containing pre-score and group allocation as independent
during the study period. variables and improvement in score as the dependent
The training group showed statistically significant im- variable. In this analysis, group allocation (training or
provements between pre-test and post-test in the GOALS? control) was no longer a statistically significant predictor of

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Table 2 Pre-scores and post-scores in the training and control groups


Type of score Group Pre-score Post-score p value
(post-score vs. pre-score)
Average Range Average Range

GOALS? score (max 35) Training group 15.1 7.3331.0 21.4 1229.7 0.002*
Control group 20.6 13.330.3 22.8 16.731.3 0.052
GEARS score (max 30) Training group 12.7 6.3326.7 18.4 9.6726.3 0.002*
Control group 17.4 1126 19.4 13.327 0.041*
Total knots Training group 1.65 05.6 3.38 1.935.73 \0.001*
Control group 2.45 0.934.87 3.42 1.936.4 \0.001*
Satisfactory knots Training group 1.04 05.07 2.73 1.134.4 \0.001*
Control group 2.02 0.934.2 2.87 15.6 0.004*
Suture sponge 1 score (max 100) Training group 49.0 385 90.7 77100 \0.001*
Control group 74.5 4494 77 6394 0.599
* Statistically significant at a p value \0.05

Table 3 Differences between


Type of score Average difference in scores (post-test minus pre-test) p value
post-scores and pre-scores in the
training and control groups Training group Control group

GOALS? score ?6.4 ?2.2 0.037*


GEARS score ?5.7 ?2.0 0.027*
Total knots ?1.73 ?0.97 0.029*
Satisfactory knots ?1.69 ?0.85 0.041*
Suture sponge 1 ?41.7 ?2.5 \0.001*
* Statistically significant at a p value \0.05

Table 4 Multivariate linear


Outcome variable (post-test minus pre-test) Independent variable 1 Independent variable 2
regression models to control for
pre-score while assessing the Group allocationa Pre-score
impact of group allocation on
improvement in score Standardized beta p value Standardized beta p value

Change in GOALS? score ?0.23 0.26 -0.48 0.02


Change in GEARS score ?0.26 0.20 -0.42 0.05
Change in total knots ?0.32 0.12 -0.37 0.07
Change in satisfactory knots ?0.22 0.26 -0.50 0.02
Change in suture sponge 1 score ?0.298 0.001 -0.765 \0.001
a
Training group coded as 1, control group coded as 0

change in GOALS? score (p = 0.26), change in GEARS cuff, extent of capturing essential anatomy, extent of cap-
score (p = 0.20), change in total knots (p = 0.12), or turing essential surgical challenges, utility for training, and
change in satisfactory knots (p = 0.26). Group allocation utility for assessment. However, ratings for proximity of
did remain a highly statistically significant predictor of the bowel and bladder, appearance of the bowel, and ap-
change in suture sponge 1 score, even after controlling for pearance of the bladder were lower: median ratings 3, 2.5,
baseline score (p = 0.001). and 3.5, respectively, suggesting that this aspect of the
Face and content validity of the vaginal cuff model were model was less realistic.
supported by surveys completed by 13 obstetrics and gy- Comparison of the scores provided by the three
necology participants, one gynecologic oncologist, and one evaluators demonstrated high internal consistency for the
gynecologic oncology fellow. Their input showed median GEARS score, GOALS?, efficiency, total knots, and sat-
ratings of four out of a maximum five for the domains of: isfactory knots (Kendalls coefficient of concordance 0.85,
shape of the vaginal cuff, resistance to suture of the vaginal 0.84, 0.75, 0.93, 0.83, respectively). Statistically significant

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correlations were found between the GOALS? score and participants with lower baseline GOALS? scores. This
the suture sponge 1 score on the same day, providing could have important implications for development of future
evidence of concurrent validity (Spearmans q 0.510, training curricula which are more appropriately tailored
p value \0.001). Suture sponge 1 pre-test score was sig- based on the participants pre-training skill level.
nificantly correlated with GOALS? score at the post-test The high inter-observer agreement for the GEARS score
(Spearmans q 0.451, p value 0.031), providing evidence of provides further evidence regarding the validity of this
predictive validity, with or without training. Strong corre- scale by an independent group. Furthermore, the high inter-
lations were found between the GOALS? score and total observer agreement for total knots and satisfactory knots
knots (Spearmans q 0.875, p value \0.001), and between and their correlation with the GEARS score suggest these
GOALS? score and satisfactory knots (Spearmans individual measurements may provide simpler substitutes
q 0.853, p value \0.001). No statistically significant dif- for the GEARS scale in the limited setting of assessing
ferences were found in injury to bowel or bladder between suturing ability. Finally, our study provides some valida-
groups or within groups at pre- versus post-test. tion of the vaginal cuff model as a training tool with face
and content validity.
In conclusion, participation in a well-defined virtual
Discussion reality training curriculum results in a trend of improved
ability to perform robotic suturing as assessed using an
Our results are in agreement with those of two other ran- inanimate task. However, statistical significance was not
domized controlled trials assessing virtual reality simula- demonstrated for the primary outcome, improvement in the
tion using the da Vinci Skills Simulator which suggest: a GOALS? score. Although our trial has limitations, taken
trend to improve in ability to perform inanimate tasks in the context of two other randomized controlled trials
robotically, less than perfect translation from virtual reality with similar results [10, 11], it suggests the need to develop
to inanimate tasks, and greatest benefit for participants with improved virtual reality exercises and supports inanimate
minimal to no prior robotic simulation or robotic surgery models as a worthwhile complement to virtual reality.
experience [10, 11]. Rather than reflecting inherent
limitations of the da Vinci Skills Simulator, which remains
a platform with great flexibility and potential, this may Conflict of interest Authors Kiely, Gotlieb, Lau, Zeng, Samoue-
rather indicate limitations of the current virtual reality lian, Ramanakumar, Zakrzewski, Brin, Fraser, Korsieporn, Drudi, and
exercises. Nevertheless, the gap in translation between Press declare that they have no conflict of interest.
virtual reality and inanimate model tasks provides support
Informed consent Informed consent was obtained from all study
for the development of inanimate robotic surgical skill participants.
curricula [23] and advanced inanimate robotic surgical
simulations [24, 25] as a possible intermediate step be- Compliance with ethical standards All procedures performed in
tween virtual reality and live surgery on patients. this study were in accordance with the ethical standards of the McGill
Faculty of Medicine Institutional Review Board and with the 1964
The main limitations of our study include baseline im- Helsinki declaration and its later amendments.
balances in pre-test scores between groups and recruitment
which did not attain our target sample size. In addition, there
were some training group participants with short training References
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