Accepted Manuscript Learning curve of robotic assisted anastomosis: Shorter than the laparoscopic technique? An educational study Benoit Lucereau, MD, MSc, Fabien Thaveau, MD, PhD, Anne Lejay, MD, PhD, Mathieu Roussin, MD, Yannick Georg, MD, MSc, Frédéric Heim, PhD, Jason T. Lee, MD, Nabil Chakfe, MD, PhD PII:
S0890-5096(16)30004-8
DOI:
10.1016/j.avsg.2015.12.001
Reference:
AVSG 2663
To appear in:
Annals of Vascular Surgery
Received Date: 3 July 2015 Revised Date:
9 December 2015
Accepted Date: 15 December 2015
Please cite this article as: Lucereau B, Thaveau F, Lejay A, Roussin M, Georg Y, Heim F, Lee JT, Chakfe N, Learning curve of robotic assisted anastomosis: Shorter than the laparoscopic technique? An educational study, Annals of Vascular Surgery (2016), doi: 10.1016/j.avsg.2015.12.001. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT 1
Learning curve of robotic assisted anastomosis: Shorter than the laparoscopic technique? An educational study.
2 3 4
Benoit LUCEREAU, MD, MSc1, Fabien THAVEAU, MD, PhD1, Anne LEJAY, MD, PhD1,
5
Mathieu ROUSSIN, MD1, Yannick GEORG, MD, MSc,1 Frédéric HEIM, PhD2, Jason T LEE,
6
MD3, Nabil CHAKFE, MD, PhD1
RI PT
7 8
1. Department of Vascular Surgery and Kidney Transplantation, University Hospital of
9
Strasbourg, Strasbourg, France.
2. Laboratoire de Physique et Mécanique des Textiles, Université de Haute-Alsace,
11
Mulhouse, France
12
3. Department of Vascular Surgery, Stanford University Medical Center, Stanford, USA
13 14
Corresponding author:
15
Fabien THAVEAU, MD, PhD
16
Department of Vascular Surgery and Kidney Transplantation,
17
Nouvel Hôpital Civil, BP 426, 67091 Strasbourg Cedex, France.
18
Tel: (33) 3 69 55 09 27
19
Fax: (33) 3 69 55 17 83
20
E-mail address:
[email protected]
M AN U
TE D
EP
21
SC
10
Original article
23 24 25
Short title: Learning curve of robotic assisted anastomosis: Shorter than the laparoscopic technique? An educational study.
26
Word count:
27
Abstract: 270 words
28
Article: 2296 words
29 30 31 32
AC C
22
ACCEPTED MANUSCRIPT 33 34 35
ABSTRACT
36
Achieving aortic anastomosis in laparoscopic surgery remains a technical challenge. The
37
Da Vinci® robot could theoretically counteract this issue by minimizing the technical
38
challenge. The aim of this study was to compare the learning curves of performing
39
vascular anastomoses by trainees without any experience using purely laparoscopic
40
versus robotic-assisted techniques.
RI PT
OBJECTIVE
SC
41 MATERIALS AND METHODS
43
Surgery residents were randomly included in the laparoscopic group (group A, n=3) and
44
the robotic group (group B, n=3). They performed 10 end-to-end anastomoses on 18-
45
mm-diameter tubular e-PTFE grafts. The parameters recorded were duration to
46
complete the anastomosis and an indirect sealing quality evaluation (ISQE) defined as
47
the following ratio: Nnumber of stitches with a distance of less than 4 mm/Ttotal
48
number of stitches.
EP
49
TE D
M AN U
42
RESULTS
51
The mean duration to perform the anastomosis decreased from 2340 s (±64) for the
52
first anastomosis to 651 s (±248) for the last in group A (p<0.05) and from 1989 s
53
(±556) to 801 s (±120) in group B (p<0.05).
54
The mean ISQE increased from 74% (±18) for the first anastomosis to 98% (±3) for the
55
last in group A (p<0.05) and decreased from 100% to 98% (±2) in group B (NS).
56
The mean duration to perform the first anastomosis was lower in group B than in group
57
A (p<0.05). The mean duration to perform the last anastomosis was not significantly
58
different between the groups.
AC C
50
ACCEPTED MANUSCRIPT 59
Sealing tended to be better in group B for the first anastomosis compared to group A.
60 CONCLUSION
62
Minimally invasive laparoscopic technique training demonstrates a learning curve to
63
perform vascular anastomoses. The robotic-assisted technique tended to improve
64
suturing skills and should be considered as a valuable tool to reduce the technical
65
learning curve.
SC M AN U TE D EP AC C
66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100
RI PT
61
ACCEPTED MANUSCRIPT 101 102 103
INTRODUCTION
104
Among these techniques, laparoscopy was proposed for the surgical care of aortic
105
disease but did not have the same popularity as endovascular techniques.
106
Dion et al. first proposed and carried out a laparoscopic approach for aortobifemoral
107
bypass in 1993 2. Coggia et al. developed the totally laparoscopic technique and
108
currently have one of the most important French experiences3 for both occlusive and
109
aneurysm aortic diseases. Mid-term and long-term outcomes are similar between
110
laparoscopic and open surgery4,5. Despite codified technical and convincing results6,
111
there has only been a slight spread of laparoscopy; in 2005, only 195 laparoscopic
112
procedures were performed in France out of 24,854 aorto-iliac revascularizations7. The
113
emergence and spread of endovascular therapies led to a decrease in open surgery
114
indications; thus, the opportunity to learn laparoscopic techniques increased. Unlike
115
other specialties within laparoscopic training that start with easy cases, few simple
116
surgical procedures are currently available in vascular surgery. Tissue dissection,
117
bleeding management, aortic clamping and anastomosis completion in a "closed" space
118
are technically challenging for surgeons who have to go through a stage of "re-learning"
119
the environment.
120
In the early 2000s, a new robotic laparoscopic technique appeared. The Da Vinci robot*
121
(Intuitive Surgical, Sunnyvale, CA, USA) has been exponentially developed in general
122
surgery, urology and gynaecology because of an easier learning curve than laparoscopy.
123
In the field of aortic surgery, a robotic system should make the use of laparoscopy easier,
124
particularly in the achievement of vascular sutures.
AC C
EP
TE D
M AN U
SC
RI PT
Minimally invasive techniques have changed surgical management of vascular patients1.
ACCEPTED MANUSCRIPT 125
Our goal was to determine whether there are differences in learning curves between
126
laparoscopic and robotic techniques to complete a safe proximal end-to-end
127
anastomosis in the field of minimally invasive aortic surgery.
RI PT
128 129 130 131 132
AC C
EP
TE D
M AN U
SC
133 134
ACCEPTED MANUSCRIPT 135 136 137
MATERIALS AND METHODS
138
was set up with three junior trainees (mean age of 26 years) with no experience in
139
laparoscopic and open surgery because it was their first year of surgical residency. The
140
second group was assigned to the Da Vinci® robot (group B) with three junior trainees
141
(mean age of 29 years); two of them were in the third year and one was in the fourth
142
year of surgical residency. All of them had prior experience in open surgery, but none
143
were experienced in laparoscopy. Ten end-to-end running sutures with a CV-3 Gore-
144
Tex® 18-mm needle (WL Gore, Inc., Flagstaff, AZ, USA) anastomosis on an 18-mm-
145
diameter GORE-TEX® Stretch vascular graft (WL Gore and associates, Inc, Flagstaff, AZ,
146
USA) were to be performed by each resident as evenly as possible. In particular, each
147
suture should include equally spaced stitches not farther than 10 mm from the edge of
148
the prosthesis. Ten end-to-end anastomoses were performed by each resident as evenly
149
as possible. In particular, each suture should include equally spaced stitches that are not
150
farther than 10 mm from the edge of the prosthesis. Each surgeon performed two hemi-
151
running sutures (posterior and anterior) to complete the anastomosis. Eight half-keys
152
were necessary to realize the knot.
153
We evaluated two types of criteria:
154
-Quantitative criteria: duration to complete the posterior wall anastomosis, the anterior
155
wall anastomosis, the knot and the total duration to complete the entire anastomosis.
156
The robot was used in the operating room after a surgical procedure as a dry lab, so the
157
installation time was not taken into account in the total duration.
158
-Qualitative criteria: indirect seal quality evaluation (ISQE) was defined as the following
159
ratio: Nnumber of stitches with a distance less than 4 mm/ Ttotal number of stitches).
160
All broken CV3 Gore-Tex® sutures were recorded by the robot and pelvic trainer.
AC C
EP
TE D
M AN U
SC
RI PT
A laparoscopic group with a pelvic trainer (Karl Storz, Tullingen, Germany) (group A)
ACCEPTED MANUSCRIPT 161 Statistical analysis was performed using a hierarchical model. To evaluate the learning
163
curves of the completion of the posterior and anterior wall knots and the overall
164
anastomosis, first in each group and then between groups, we performed a linear mixed
165
model, including a "group" effect (group A and B), a "time" effect (anastomosis 1-10), a
166
"subjects" effect, and an interaction between "group" and "time". The "subjects" effect is
167
a random effect.
168
The statistical tests of interest were as follows:
169
- Time, which will assess whether the completion speed decreases over time
170
- Group, which will assess whether the implementation speed is different from the first
171
anastomosis
172
- The interaction between "group" and "time", which will assess whether the reduction
173
in production time is higher in group A than in group B.
174
Significance was defined as p <0.05.
175
To evaluate the tightness, the statistical analysis was performed using a Poisson model
176
with an offset.
SC
M AN U
TE D
EP AC C
177 178
RI PT
162
ACCEPTED MANUSCRIPT 179 180 181
RESULTS
182
30 anastomoses.
183
Quantitative Analysis
184
In group A, the mean time for completion of the posterior wall decreased from 1321 ±
185
75 sec for completion of the first anastomosis to 329 ± 172 sec for the tenth anastomosis
186
(p <0.05) (Figure 1). In group B, the mean time for completion of the posterior wall
187
decreased from 1087±439 sec for completion of the first anastomosis to 379± 87 sec for
188
the tenth anastomosis (p <0.05).
189
Upon comparing the results between the two groups, no significant difference was found
190
for completion of the posterior wall.
191
In group A, the mean time for completion of the anterior wall decreased from 560 ± 165
192
sec for completion of the first anastomosis to 254 ± 102 sec for the tenth anastomosis
193
(Figure 2) (p <0.05). In group B, the mean time for completion of the anterior wall
194
decreased from 739±173 sec for completion of the first anastomosis to 293±76 sec for
195
the tenth anastomosis (p <0.05).
196
Upon comparing the results between the two groups, no significant difference was found
197
for completion of the anterior wall.
198
In group A, the mean time for completion of the knot decreased from 458 ± 169 sec for
199
completion of the first anastomosis to 65 ± 9 sec for the tenth anastomosis (p <0.05)
200
(Figure 3). In group B, the mean time for completion of the knot decreased from 161±36
201
sec for completion of the first anastomosis to 129±35 sec for the tenth anastomosis (p
202
<0.05).
AC C
EP
TE D
M AN U
SC
RI PT
Group A made 29 anastomoses (one per procedure withdrawal), and Group B performed
ACCEPTED MANUSCRIPT 203
Upon comparing the results of the two groups, a significant (p<0.05) difference was
204
found on the first anastomosis in favour of group B and in favour of group A on the tenth
205
anastomosis.
206 In total, group A made the first anastomosis in 2340 s (± 64) and the tenth anastomosis
208
in 651 s (± 248) (Figure 4) (p <0.05); group B made its first anastomosis in 1989 s (±
209
556) and the tenth anastomosis 801 s (± 120) (p <0.05).
210 211
Comparing the results of the two groups, the total time to complete the anastomosis was
212
significantly shorter in group B than in group A for the first anastomosis (p<0,05).
SC
Qualitative Analysis
M AN U
213 214 215 216
RI PT
207
In groups A and B, all sutures were performed with regularity; no stitches had a width of up to 10 mm.
218
In group A, the ISQE increased from 74±18% (first anastomosis) to 98±3% (tenth
219
anastomosis) (Figure 5). There was no significant difference between the first and tenth
220
anastomosis. In group B, the ISQE in the first anastomosis was 100% (± 0) and 98% (±
221
2) in the tenth anastomosis. There was no significant difference demonstrated between
222
the first seal and the tenth anastomosis.
223
Upon comparing the ISQE between each group, no significant difference was found.
224
Nevertheless, there was a trend in favour of group B for the first anastomoses.
225
In group A, there was no yarn breakage during the study. In group B, on the first
226
anastomosis, three CV3 Gore-Tex® sutures ruptured, two on the second and one on the
227
third anastomosis. Then, no breakage was observed.
228 229 230 231 232 233 234
AC C
EP
TE D
217
ACCEPTED MANUSCRIPT 235 236 237 238 239
DISCUSSION
240
learning these new technical skills explains the low expansion rate of this surgery.
241
Laparoscopy creates a closed space in 2-D vision, reversed management, no ergonomic
242
position, dissociation between eye-hand coordination and reduced instrument
243
movement degrees. Robot technology should compensate for these constraints and help
244
surgeons overcome difficulties with the laparoscopic technique. Urologists and digestive
245
surgeons investigated the difference in the learning curve between robotics and
246
laparoscopy
247
Similarly, for minimally invasive surgery for aortic anastomosis (which appears to be
248
the main technical difficulty
249
facilitation. However, for completion of an anastomosis with the robot and laparoscopy,
250
Nio et al. showed that the robot does not decrease the learning curve. We believe that
251
we used a more sophisticated robot, offering more degrees of freedom and better vision
252
than AESOP 13.
we believe that the robot provides technical
TE D
11,12),
M AN U
and observed an improved technical skill because of the robotics.
EP
8-10
SC
RI PT
Minimally invasive techniques have changed the face of open surgery. However,
Yohannes et al. described a large performance improvement with training on the
254
robot 8. After comparing different suture exercises and dexterity on the robot and pelvic
255
trainer, they observed a learning curve in laparoscopic and robotic methods, but the
256
learning curve was faster on the robot with inexperienced surgeons. According to these
257
results, in our study considering the total time for residents to complete the first
258
anastomosis, learning with the robot is faster than learning the laparoscopic technique.
AC C
253
259
In both groups, we observed a significant decrease in completion time of each
260
part of the anastomoses despite a low number of junior trainees. Nevertheless, we did
261
not find any differences between the two groups for anterior and posterior wall
ACCEPTED MANUSCRIPT 262
suturing. However, with the total anastomosis time, the robotic technique offers faster
263
handling than laparoscopy. In a prospective study of 34 students, Stefanidis et al.
264
demonstrated that the robot had a faster learning curve than laparoscopy7 9 when using
265
a porcine Nissen fundoplication model. At the end of the exercise, junior trainees had to perform a knot, which is
267
technically challenging because it requires all degrees of freedom to reproduce human
268
hand movement in addition to surgical experience. In our study, the seven degrees of
269
freedom of the robot allowed group B to complete the knot more quickly (The difference
270
observed on the tenth anastomosis can be explained by the statistical analysis; we
271
compared the slope of the curve, and it is higher with the laparoscopic technique). In a
272
prospective study comparing laparoscopy and robotics, Chandra et al. demonstrated
273
that novice surgeons performed complex tasks such as knots better with robotics than
274
with the laparoscopic technique 10.
M AN U
SC
RI PT
266
ISQE is a ratio developed to objectively determine the quality of an anastomosis.
276
It was defined after an in vitro test. End-to-end anastomoses with different gaps
277
between stitches (3, 4 and 5 mm) were subjected to a flow of water under pressure.
278
Sealing was obtained with points that were less than 4 mm apart. Even with the absence
279
of scientific value, this ratio has allowed us to observe an increase in the regularity of
280
anastomoses, a decrease in the number of broken CV3 Gore-Tex® sutures and, indirectly,
281
an objective learning curve. Moreover, even if there was no difference in terms of sealing
282
between the two groups, the robot seems to be easier at the beginning in order to
283
achieve a quicker waterproof anastomosis.
AC C
EP
TE D
275
284
The easier needle-driver manipulation, needle position anticipation, and learning
285
hand-eye dissociation and dexterity allowed this improvement in each group. Freedom
286
of the robotic instruments, 3-D vision and the lack of tremors improved the learning
ACCEPTED MANUSCRIPT 287
curve of group B. The robot does not offer force feedback. We observed suture breakage
288
on the first anastomosis (not affecting anastomosis completion time). However, by the
289
fourth anastomosis, the operators were able to compensate for this lack of force
290
feedback by sight and habit. The choice of an in vitro end-to-end anastomosis is based on our own surgical
292
experience. Although the literature does not demonstrate the superiority of a technique
293
(end-to-end or end-to-side), these anastomoses seem to offer better hemodynamic
294
results and a reduction in false aneurysms14,15. Because we perform most of our
295
proximal anastomoses in end-to end mode, in cases of occlusive disease or aneurysms,
296
our choice for the model was this suture technique.
M AN U
SC
RI PT
291
Several limiting factors were observed in this study. Even with a small number of
298
junior trainees in both groups, the number of anastomoses performed was enough to
299
achieve a statistically significant evaluation of both techniques. Although the number of
300
anastomoses per participant was sufficient to observe a learning curve, extending this
301
study to increase the number of junior trainees and include a group of senior trainees
302
may be interesting and valuable.
EP
TE D
297
One of the challenges of this new model was to objectively assess the
304
anastomoses. For this purpose, we selected surgeons without technical knowledge that
305
allowed us to avoid the apprehension of senior surgeons in using this technique.
306
Contrary to our original assumption, the learning curve of the robotic surgical
307
anastomosis was fast in spite of the inexperience of the residents. Dexterity quickly
308
obtained with the robotic technique counterbalances the apprehension of the machine.
AC C
303
309
.
310
We chose to evaluate two criteria that seem relevant to the study: quantitative
311
and qualitative (Time and ISQE). These criteria allow observation of an evolution in
ACCEPTED MANUSCRIPT learning minimally invasive techniques. The educational portion of this study is to later
313
develop a score that will allow us to evaluate the evolution of residents and create a
314
threshold that would allow them to perform the procedure in vivo. Simulation therefore
315
enables development of skills in order to improve surgical performance 16. Currently, all
316
of our residents use this model to assess their progress and practice the techniques.
317
Furthermore, with the increasing availability of the robot, this model is easy to
318
reproduce in a training centre, enabling a diffusion model.
SC M AN U TE D EP AC C
319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353
RI PT
312
ACCEPTED MANUSCRIPT 354 355 356
CONCLUSION
357
to be quicker than that of laparoscopic surgery. Compared to laparoscopy, the robot
358
allowed faster, more accurate and easier learning of technical skills on the first
359
anastomoses. Robotics may offers the opportunity for surgeons to more quickly acquire
360
skills to perform a technique that is deemed difficult and, therefore, may provide better
361
reproducibility.
RI PT
SC M AN U TE D EP AC C
362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396
Although the results appear similar in both techniques, the robotic learning curve seems
ACCEPTED MANUSCRIPT Acknowledgement: All prosthesis and yarns were provided free of charge by WL Gore and
398
Associate, Inc.
SC M AN U TE D EP AC C
399 400 401 402 403 404 405 406 407 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444
RI PT
397
ACCEPTED MANUSCRIPT REFERENCES 1-Lin JC. The role of robotic surgical system in the management of vascular disease. Ann Vasc Surg. 2013;27(7):976-83
449 450
2- Dion YM, Katkhouda N, Rouleau C et al. Laparoscopy-assisted aortobifemoral bypass. Surg Laparosc Endosc 1993 ; 3 : 425-9
451 452
3- Coggia M, Bourriez A, Javerliat I, et al .Totally Lapararoscopic aortobifemoral bypass : a new and simplified approach. Eur J Vasc Endovasc Surg 2002 ; 24 :274-5
453 454
4-Fukui S, Alberti V, Mallios A, et al. Early and mid-term results of total laparoscopic bypass for aortoiliac occlusive lesions. J Cardiovasc Surg (Torino). 2012; 53: 235-9
455 456
5-Cochennec F, Javerliat I, Di Centa I et al. A comparison of total laparoscopic and open repair of abdominal aortic aneurysms. J Vasc Surg 2012; 55: 1549-53
457 458 459
6- Coscas R, Maumias T, Capdevila C et al. Mini-invasive treatment of abdominal aortic aneurysms: current roles of endovascular, laparoscopic, and open techniques. Ann Vasc Surg. 2014;28(1):123-31
460 461
7- L B. Evaluation de la chirurgie vasculaire par coelioscopie. In: professionnels séda, editor.: Haute Autorité de Santé; 2009. p. 6
462 463
8- Yohannes P, Rotariu P, Pinto P et al. Comparison of robotic versus laparoscopic skills: is there a difference in the learning curve? Urology. 2002; 60: 39-45
464 465 466
9- Stefanidis D, Wang F, Korndorffer JR et al. Robotic assistance improves intracorporeal suturing performance and safety in the operating room while decreasing operator workload. Surg Endosc. 2010; 24: 377-82
467 468
10- Chandra V, Nehra D, Parent R, et al. A comparison of laparoscopic and robotic assisted suturing performance by experts and novices. Surgery 2010; 147: 830-9
469 470
11- Rouers A., Meurisse N., Lavigne J.P. et al, Potential benefits of laparoscopic aortobifemoral bypass surgery. Acta Chir Belg. 2005;105:610–615
471 472 473
12- Kolvenbach R., Puerschel A., Fajer S., et al. Total laparoscopic aortic surgery versus minimal access techniques: review of more than 600 patients. Vascular. 2006;14:186– 192
474 475 476 477 478 479 480
13- Nio D1, Bemelman WA, Balm R, et al. Laparoscopic vascular anastomoses: does robotic (Zeus-Aesop) assistance help to overcome the learning curve? Surg Endosc. 2005;19(8):1071-6
AC C
EP
TE D
M AN U
SC
RI PT
445 446 447 448
14- Brewster DC, Darling RC. Optimal methods of aortoiliac reconstruction. Surgery. 1978; 84(6):739-48
ACCEPTED MANUSCRIPT 15- Mikati A1, Marache P, Watel A and al. End-to-side aortoprosthetic anastomoses: long-term computed tomography assessment. Ann Vasc Surg. 1990; 4(6):584-91
EP
TE D
M AN U
SC
RI PT
16- Lendvay TS, Brand TC, White L et al. Vitrual reality robotic surgery warm-up improves task performance in a dry laboratory environment : a prospective randomized controlled study. J Am Coll Surg. 2013; 216(6) :1181-92
AC C
481 482 483 484 485 486 487
ACCEPTED MANUSCRIPT LEGENDS: Figure 1: Evolution of time completion of the posterior wall for group A and group B. Figure 2: Evolution of time completion of the anterior wall for group A and group B. Figure 3: Evolution of time completion of the knot for group A and group B.
EP
TE D
M AN U
SC
Figure 5: Evolution of ISQE in group A and B.
RI PT
Figure 4: Evolution of the total time completion of anastomoses for group A and group B.
AC C
488 489 490 491 492 493 494 495 496 497 498 499 500 501
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT