Robotic Assistance Confers Ambidexterity to Laparoscopic Surgeons

Robotic Assistance Confers Ambidexterity to Laparoscopic Surgeons

Accepted Manuscript Title: Robotic Assistance Confers Ambidexterity to Laparoscopic Surgeons. Author: Souzana Choussein, Serene S. Srouji, Leslie V. F...

843KB Sizes 192 Downloads 93 Views

Accepted Manuscript Title: Robotic Assistance Confers Ambidexterity to Laparoscopic Surgeons. Author: Souzana Choussein, Serene S. Srouji, Leslie V. Farland, Ashley Wietsma, Stacey A. Missmer, Michael Hollis, Richard N. Yu, Charles N. Pozner, Antonio R. Gargiulo PII: DOI: Reference:

S1553-4650(17)30397-7 http://dx.doi.org/doi: 10.1016/j.jmig.2017.07.010 JMIG 3198

To appear in:

The Journal of Minimally Invasive Gynecology

Received date: Revised date: Accepted date:

17-12-2016 28-6-2017 6-7-2017

Please cite this article as: Souzana Choussein, Serene S. Srouji, Leslie V. Farland, Ashley Wietsma, Stacey A. Missmer, Michael Hollis, Richard N. Yu, Charles N. Pozner, Antonio R. Gargiulo, Robotic Assistance Confers Ambidexterity to Laparoscopic Surgeons., The Journal of Minimally Invasive Gynecology (2017), http://dx.doi.org/doi: 10.1016/j.jmig.2017.07.010. 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.

Choussein 1

Robotic assistance confers ambidexterity to laparoscopic surgeons.

2

Souzana Choussein, M.D.1, Serene S. Srouji, M.D.1, Leslie V. Farland ScD2, Ashley

3

Wietsma, M.D.3, Stacey A. Missmer ScD1,4, Michael Hollis , B.S.3, Richard N. Yu,

4

M.D., PhD.3, Charles N. Pozner, M.D.5, Antonio R. Gargiulo, M.D.1

1

5 6

1

7

and Reproductive Biology, Brigham and Women’s Hospital, Harvard Medical School,

8

Boston, Massachusetts

9

2

Center for Infertility and Reproductive Surgery, Department of Obstetrics, Gynecology

Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston,

10

Massachusetts

11

3

12

Massachusetts

13

4

14

Massachusetts; Channing Division of Network Medicine, Brigham and Women's Hospital

15

and Harvard Medical School, Boston, Massachusetts

16

5

17

School, Boston, Massachusetts; Department of Emergency Medicine, Brigham and

18

Women's Hospital, Harvard Medical School, Boston, Massachusetts.

Department of Urology, Boston Children's Hospital, Harvard Medical School, Boston,

Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston,

Neil and Elise Wallace STRATUS Center for Medical Simulation, Harvard Medical

19 20

Corresponding author: Antonio R. Gargiulo, MD

21

Center for Infertility and Reproductive Surgery, Brigham and Women’s Hospital,

22

Harvard Medical School, 75 Francis St., ASB1-3, Boston, MA, 02115;

23

Tel: +1-617-732-4285; Fax: +1-617-975-0870; email: [email protected]

Page 1 of 26

Choussein

2

24

Disclosures: Dr. Gargiulo serves as a Consultant for Medicaroid, Inc. and OmniGuide

25

Holdings, Inc. Drs. Choussein, Srouji, Wietsma, Yu, Farland, Missmer, Hollis and Pozner

26

have no conflicts of interest or financial ties to disclose.

27

Funding: Nothing to report.

28 29

Precis: Robot-assisted laparoscopy eliminates the operative handedness observed in

30

conventional laparoscopy, conferring virtual ambidexterity to surgeons in training.

31 32

ABSTRACT

33

Study objective: To examine whether a robotic surgical platform can complement the

34

fine motor skills of the non-dominant hand, compensating for the innate difference in

35

dexterity between the surgeon’s hands, thereby conferring virtual ambidexterity.

36

Design: Crossover intervention study.

37

Design classification: Level II-1 evidence.

38

Setting: Centers for medical simulation of two tertiary care hospitals of Harvard Medical

39

School.

40

Participants: Three different cohorts of subjects were included: 1) surgical novices

41

(medical graduates with no robotic/laparoscopic experience) 2) surgeons in training

42

(PGY3-4 residents and fellows with intermediate robotic and laparoscopic experience)

43

and 3) advanced surgeons (attending surgeons with extensive robotic and laparoscopic

44

experience).

45

Interventions: Each study group completed three dry lab exercises based on exercises

46

included in the Fundamentals of Laparoscopic Surgery (FLS) curriculum. Each exercise

47

was completed four times: using their dominant and non-dominant hand, on a standard

Page 2 of 26

Choussein

3

48

laparoscopic FLS box trainer and in a robotic dry lab set-up. Participants were

49

randomized to the handedness and setting order in which they tackled the tasks.

50

Measurements and Main Results: Performance was primarily measured as time to

51

completion, with adjustments based on errors. Means of performance for the dominant

52

versus non-dominant hand for each task were calculated and compared using a repeated

53

measures ANOVA test.

54

A total of 36 subjects were enrolled study-wide (12 per group). In the laparoscopic

55

setting, the overall time to completion for all three tasks with the dominant hand was

56

significantly different from that with the non-dominant hand (439.4s vs. 568.4s

57

respectively; p=.0008). The between-hand performance difference was nullified with the

58

robotic system (374.4s vs. 399.7s;p=.48). Evaluation of performances for each individual

59

task also revealed a statistically significant disparate performance between hands for all

60

three tasks when the laparoscopic approach was utilized (p=.003, p=.02, p=.01

61

respectively). No between-hand difference was observed when the tasks were performed

62

robotically. When the above analysis was performed within the three surgical experience

63

cohorts, the performance advantage of robotic technology remained significant for the

64

surgical novices and intermediate level experience groups.

65

Conclusion: Robot-assisted laparoscopy may eliminate the operative handedness

66

observed in conventional laparoscopy, allowing for virtual ambidexterity. Such

67

ergonomic advantage is particularly evident on surgical trainees. Virtual ambidexterity

68

may represent an additional aspect of surgical robotics that facilitates mastery of

69

minimally-invasive skills.

Page 3 of 26

Choussein 70

Keywords: robotic surgery, laparoscopic surgery, intraoperative handedness,

71

ambidexterity, daVinci surgical system

4

72 73

Presented at the 45th AAGL Annual Global Congress On Minimally Invasive

74

Gynecology, Orlando, FL. November 14-18, 2016 (oral presentation, Plenary Robotics

75

Session).

76 77

Page 4 of 26

Choussein

5

78

INTRODUCTION

79

Ambidexterity has been identified as a critical factor in the achievement of laparoscopic

80

psychomotor surgical skill proficiency, and constitutes a desirable attribute for all

81

surgeons.[1-3] In terms of efficiency optimization, this is a particularly useful adjunct in

82

minimally invasive surgery, where the capabilities of instrument switching or body

83

position readjustment are limited. This often necessitates the use of the surgeon’s non-

84

dominant hand for delicate and precise tasks.[4] True ambidexterity, however is rare [5],

85

and possibly nonexistent.[6]

86

The robotic surgical platform has provided several ergonomic advancements to the field

87

of minimally invasive surgery, including the physiologic use of the surgeon’s wrist,

88

tremor filtration, motion scaling and three-dimensional vision. These advantages have

89

contributed to its increasing acceptance and growth as an alternative minimally invasive

90

surgical option. These same advantages have been proposed as the main factors that

91

shorten the learning curve of surgical skills: an important benefit, given the relatively

92

extensive learning period required to acquire these skills using laparoscopic platforms.

93

[7, 8] Access to virtual reality simulation, employing commercially available integrated

94

training protocols is another aspect of robotic surgery that has been shown to facilitate

95

negotiation of the surgical learning curve.[9] In summary, several aspects of robotic

96

surgery contribute to technical proficiency being achieved through a shorter and more

97

patient-centered learning curve compared to other types of invasive and minimally

98

invasive surgical techniques. Virtual ambidexterity in the robotic setting may constitute

99

an additional factor explaining the "enabling" role of computer-assisted laparoscopy and

100

its truncated learning curve.

Page 5 of 26

Choussein

6

101 102

There are two studies that previously examined the impact of the robotic platform on

103

surgeon’s handedness. However, none of them used experience-based stratification of the

104

study population, and neither introduced a laparoscopic component, as they both

105

examined open vs. robotic approaches. [10, 11]

106

With the majority of surgical operations now being performed via minimally invasive

107

routes, a study assessing the impact of robotic-assistance on hand dominance as

108

compared to laparoscopy appears more relevant than prior published literature that only

109

used an open surgery arm of comparison.

110

Given the aforementioned gap, the current study aims to examine whether robotic

111

systems, as compared to laparoscopy, can augment fine motor skills of the non-dominant

112

hand, compensating for surgeon’s innate difference in dexterity between each hand, and

113

thus conferring “virtual” ambidexterity.

114 115

MATERIALS AND METHODS

116

Subjects and Design

117

This was a crossover intervention study conducted at the Neil and Elise Wallace

118

STRATUS Center for Medical Simulation of Brigham and Women’s Hospital and at

119

Boston Children’s Hospital; both Harvard affiliated academic medical centers in Boston.

120

Brigham and Women’s Hospital and Boston Children’s Hospital Institutional Review

121

Board approvals were obtained. Volunteers were solicited from the Obstetrics &

122

Gynecology and Urology Departments of the aforementioned hospitals.

Page 6 of 26

Choussein

7

123

An email invitation was extended to the eligible staff members of the aforementioned

124

departments and their satellites, and participation was determined based on matched

125

availability (of the potential participant on the one end and the required facility on the

126

other). The study population was composed of three groups: Group 1: Surgical novices

127

with no robotic or laparoscopic experience i.e medical graduates with no residency

128

training (Surgery-naive subjects); Group 2: Surgeons in training (PGY 3-4 residents and

129

fellows with intermediate robotic and laparoscopic experience); and Group 3: Advanced

130

surgeons (attending surgeons with extensive robotic and laparoscopic experience).

131

Novice group was comprised of surgically untrained medical graduates serving as

132

Research Fellows at Obstetrics & Gynecology and Urology Departments of the

133

aforementioned hospitals. All of the residents and fellows included in this study (as

134

Group 2) had completed structured, stepwise curriculum requirements which included

135

standardized robotic simulation exercises, case observations, and stepwise involvement at

136

the console on live patient surgeries. At the time of their involvement on the study, all

137

had completed the basic requirements and had been fully involved in live console

138

surgery. Similarly, they had had several years of exposure to laparoscopic surgery, as part

139

of the standardized curricula for Accreditation Council for Graduate Medical Education

140

(ACGME)-accredited Obstetrics and Gynecology and Urology residency and fellowship

141

programs. Surgeons in Group 3 held robotic privileges at their institutions and reported

142

performing a minimum of 250 robotic cases and a minimum of 250 laparoscopic cases at

143

the time of enrollment. Individuals who self-reported as ambidextrous were excluded

144

from the study. All enrolled subjects watched a short video tutorial developed by an

145

expert surgeon. The video used a step-by-step process to demonstrate each task –

Page 7 of 26

Choussein

8

146

performed both laparoscopically and robotically-, and oriented participants to the

147

instruments used, ideal body positioning, and skills specific to the robot such as master

148

clutching. Each participant completed a short questionnaire at enrollment that collected

149

information about their demographics, current surgical case loads and prior experience

150

with surgical simulators and computer games.[12]

151

To assess differences in hand dexterity between the laparoscopic and robotic surgical

152

approach, each subject performed two sets (laparoscopic and robotic) of three exercises

153

inspired by skill tests required for the Fundamentals of Laparoscopic Surgery (FLS)

154

certification. Only those FLS skill tests that can be performed both laparoscopically and

155

with the robot were utilized. These are: the peg transfer (PT), the precision cutting (PC),

156

and the intracorporeal suturing (IS). Such skill tests were modified to serve the unilateral

157

performance requirement of the study. Other FLS skill tests not included in our study

158

were the endoloop placement and the extracorporeal suturing/knot tying.[8] Construct

159

validity of the FLS model has been demonstrated for robotic surgery. [5, 13] Exercises

160

were completed on a standard FLS box trainer (Limbs and Things, Savannah, GA)

161

located in a medical simulation center, for the laparoscopic arm. For the robotic arm,

162

exercises were completed in a robotic dry lab set-up. This involved the use of all the

163

components of the robot (surgical console, patient-side cart, EndoWrist instruments, and

164

vision cart) and the lower tray of a standard FLS laparoscopic box trainer, containing the

165

FLS test disposables.

166

We utilized a modified version of the PT task, eliminating the bi-manual subcomponents

167

of the original FLS curriculum, so that one hand at a time could be evaluated.

168

Specifically, each subject was asked to grasp six rubber objects placed on a pegboard,

Page 8 of 26

Choussein

9

169

one at a time, with a Maryland grasper and place them on a peg on the opposite side of

170

the board. (Figure 1.) The PC task required participants to cut out a circle from a 4x4

171

gauze piece suspended between clips, by cutting between two premarked circular

172

tracings. Participants were instructed to use a Maryland grasper in one hand to provide

173

traction and exposure on the gauze and to place it at the best possible angle to the cutting

174

hand being evaluated. No instrument exchange between hands was allowed. (Figure 2.)

175

Being largely bimanual, the IS task was also modified to serve our study aim. Participants

176

were required to drive a 2.0 Silk suture of 15cm length through two marks on a stationary

177

Penrose drain, starting the task with the designated hand being examined. Both hands

178

were occupied with curved needle-drivers. Once the needle was passed, the participants

179

were required to tie two double throws and one single throw by tying with the hand under

180

examination and the other hand holding the suture with the needle. (Figure 3.) These

181

modifications of the original FLS skill tests allowed for each task to be performed using

182

the dominant or the non-dominant hand, one at a time. Each participant completed each

183

task both laparoscopically and robotically on the same day. Robotic procedures were

184

performed using the da Vinci Surgical System (Intuitive Surgical Inc, Sunnyvale, CA).

185

Participants were randomized to which hand (dominant vs. nondominant) and setting

186

(laparoscopic vs. robotic) was completed first; there was no alternation in setting and all

187

three tasks were performed in-series prior to moving to the remaining setting.

188

Performance Assessment

189

To assess the differential in hand performance afforded by the laparoscopic versus the

190

robotic approach, the raw time for task completion was recorded. A time penalty was

191

applied for errors or lack of precision according to Table 1.

Page 9 of 26

Choussein 10 192

Statistical Analysis

193

The sample size of our study with paired subjects was sufficient to detect a 10% mean

194

difference (in seconds) between the subject’s dominant and non-dominant hand. This

195

threshold was chosen a priori to reflect the minimum difference between hands and

196

between laparoscopic and robotic modality that would be clinically meaningful with

197

respect to surgery (here quantified by the skills tests) duration. Given this minimum

198

detectable clinically meaningful difference, we calculated the sample size requiring a

199

minimum of 80% power and an α-level=0.05, using a repeated measures ANOVA

200

statistical approach.

201

Given the crossover study design [14] and the randomization of handedness and setting

202

order in which the participants tackled the tasks, there is little concern about any

203

confounding that remains between groups.[15] Mean values of performance using

204

dominant versus non-dominant hand in the laparoscopic and the robotic setting were

205

compared using a repeated measures ANOVA to take into account correlation between

206

measurements. Analyses were stratified by level of training. Sensitivity analyses were

207

conducted using generalized estimating equations (GEE) with robust “sandwich”

208

standard error estimates for linear regression. Findings from this sensitivity analysis were

209

not different from the original analysis and thus the repeated measures ANOVA results

210

are presented in the manuscript and all tables.

211 212

RESULTS

213

A total of 36 subjects were enrolled in the study with 12 in each group, each with four

214

timed measurements. Among novices, one was unable to complete the laparoscopic IS

Page 10 of 26

Choussein 11 215

task and thus, that individual’s results were excluded from the entire study. Gender and

216

handedness distribution among groups as well as prior experience with computer games

217

and simulators are shown in Table 2. The majority of our sample was male (62.5%) and

218

right-handed (98.2%). Approximately half of our subjects had previous experience with

219

laparoscopic or robotic simulators, not including our novice group which was simulator-

220

naive. Forty three percent reported prior experience with computer games, however

221

experience with computer games was most commonly reported among the novice group.

222

Surgical case load (either laparoscopic or robotic) and time since last surgical case

223

(applicable only to intermediate and advanced experience groups) are also noted. Among

224

the intermediate group, the average number of cases/week was 2.7 and the reported time

225

since last case ranged between 0 and 96 weeks, with a median of 12.5 weeks. Among the

226

expert group, average number of cases/week was 3.7; all of them reported performing a

227

surgery within the preceding two weeks.

228

Table 3 displays an assessment of the overall completion time of all three of the technical

229

tasks combined using laparoscopic and robotic approaches. In the laparoscopic setting,

230

the cumulative execution time with the dominant hand was significantly shorter than with

231

the non-dominant hand (439.4s vs. 568.4s respectively; p=.0008). This difference was

232

nullified when the technical tasks were performed on the robot (dominant: 374.4s vs.

233

non-dominant: 399.7s; p=.48). Of note, the median overall time to completion with either

234

the dominant or non-dominant hand was almost identical when the subjects used the

235

robot (dominant: 322s vs. non-dominant: 324s). Cumulatively, the mean difference in

236

raw time scores between the two hands for all three tasks was also significantly shorter

Page 11 of 26

Choussein 12 237

when the robot was utilized as compared to laparoscopic performance respectively (76.9s

238

vs. 167.8s; p<.0001).

239

Evaluation of each task individually also revealed a statistically significant difference in

240

performance between hands for all PT, PC, IS when the laparoscopic approach was

241

utilized (p=.003, p=.02, p=.01 respectively). No statistically significant between-hand

242

difference was observed when the tasks were performed robotically. (Table 4)

243

When stratifying by experience, the minimization of handedness afforded by the robotic

244

platform remained statistically significant among novice and intermediate operators.

245

In particular, we observed a statistically significant between-hand difference in the

246

laparoscopic setting performance of both novices and intermediate-level operators

247

(dominant: 666.0s vs. non-dominant: 988.6s; p=.01 and dominant: 351.5.0s vs. non-

248

dominant: 437.8s; p=.02, respectively) but not of the expert group (dominant: 319.6s vs.

249

non-dominant: 313.7; p=.82) No difference in relative hand performance was observed

250

for the novice and intermediate subjects when the tasks were performed robotically;

251

however, a difference was noted for the expert group. (dominant: 251.8s vs. non-

252

dominant: 297.3; p=.004). (Table 5)

253 254

DISCUSSION

255

For surgeons, it has been argued that ambidexterity represents a professional advantage,

256

if not an implicit requirement. [16, 17] Robotic surgical platforms appear to complement

257

motor skills of the non-dominant upper limb, thereby conferring virtual ambidexterity.

258

This is another piece of the puzzle to explain, in a scientific way, the "enabling" nature of

259

robot-assisted surgery.[10, 11] Virtual ambidexterity may represent an additional aspect

Page 12 of 26

Choussein 13 260

of surgical robotics that facilitates mastery of minimally-invasive skills through a

261

truncated, patient-friendly learning curve.

262

Technological innovations, health care cost considerations and patients’ expectations of

263

modern surgery, have all contributed to make minimally invasive surgery, the gold

264

standard for most intra-abdominal operations. Yet, the skill set needed for advanced

265

laparoscopy is hard to master due to the fundamental ergonomic challenges associated

266

with working through a fulcrum (anterior abdominal wall), the lack of three-dimensional

267

vision, and a reduced range of motion as a result of the inability to use wristed action

268

movements. Due to these limitations, even the surgeon’s innate dexterity cannot be fully

269

exhibited, as he or she negotiates the learning curve.[18, 19] Being hard to learn,

270

laparoscopy is harder to teach through the classic “see one, do one, teach one” model.

271

Robotic surgery is poised to address these limitations. To take it a step further,

272

eliminating intraoperative handedness can be expected to positively impact the surgical

273

learning curve, particularly benefitting surgical trainees and surgeons at the early stages

274

of their robotic learning curve, as shown by our data.

275

Studies demonstrating enhanced dexterity with the use of a robotic surgical system over

276

traditional laparoscopy have frequented the literature.[6, 18, 20] In an attempt to quantify

277

the purported advantage of robotic approaches vs. laparoscopy, Moorthy et al. reported a

278

nearly 50% increase in dexterity when employing the robot; attributing this to the tremor

279

cancellation, motion scaling and seven degrees of freedom (i.e specific, defined modes in

280

which a mechanical system can move) afforded by the robot.[18] Also, there is published

281

evidence that bimanual object manipulation is mediated by callosal fibers that

282

interconnect the cerebral hemispheres and that there is a preferential activation of this

Page 13 of 26

Choussein 14 283

human “mirror” system in surgeons operating with the robotic system compared with

284

those performing conventional laparoscopy.[21]

285

As previously mentioned, the impact of a robotic surgical system on a surgeon’s

286

handedness has been examined.[10, 11] Mucksavage et al. conducted manual dexterity

287

assessments of 19 robotic novices using open and robotic approaches to perform the

288

Purdue Pegboard test – in which participants must place as many peg assemblies into the

289

board as possible within a 30-second interval- and a needle targeting test where

290

participants were asked to hit as many bull’s eye paper targets as possible within 10

291

seconds. The performance scores for each hand were statistically different when the open

292

approach was used; however this difference was nullified when the tasks were performed

293

robotically.[11] In a similarly designed study, Badalato et al. concluded that robotic

294

surgery is capable of eliminating handedness among relative novices who performed

295

basic manual dexterity skill tests modified from FLS using the open and the robotic

296

technique.[10]

297

In the era of minimally invasive surgery, comparing the facilitation of ambidexterity

298

between laparoscopic skills and robotic skills is more germane than any comparison with

299

an open approach. Our study is the first to specifically address this question.

300

This study revealed a statistically disparate performance between hands for all three tasks

301

when the laparoscopic approach was utilized. The use of the robot resulted in leveling of

302

performance between the dominant and the non-dominant hand. Equilibration of hand

303

performance has been attributed to enhanced performance of the non-dominant hand as a

304

result of either tremor filtration or motion scaling.[22] Published evidence has established

305

that motion scaling rather than tremor filtration, is primarily responsible for the enhanced

Page 14 of 26

Choussein 15 306

accuracy observed with robotic assistance with more prominent gains in the non-

307

dominant, innately less dexterous, hand.[20, 23]

308

We felt that the multidimensional skill set and versatile technical attributes required

309

during an actual surgical operation are better reflected when combining the results of all

310

three tasks; that was the rationale for calculating and analyzing cumulative execution

311

time. Even in this context, the significant between-hand difference in overall time to

312

completion that was noted when the tasks were performed laparoscopically, was negated

313

when switching to the robotic setting.

314

These results are consistent with the findings of the aforementioned pertinent studies.

315

None of the pre-existing studies, however, has used an experience-based stratification of

316

the study population. At a time where a philosophy of patient-centered medicine is

317

shaping the way we can ethically teach surgery, we strongly believed that this type of

318

study should stratify subjects by surgical experience. Assuming that pure novices and

319

robotic experts occupy the two edges of the robotic surgery experience spectrum, there

320

should be an intermediate one in between them to span it entirely. This is, at its best,

321

represented by senior residents and fellows, and that was the rational for selecting the

322

intermediate study groups as such.

323

In the laparoscopic setting, we found a statistically significant between-hand difference

324

in the performance of both novices and intermediate-level operators. This difference was

325

not identified in the expert group. In the robotic setting, no difference in relative hand

326

performance was observed in the novice and intermediate subjects. However, a difference

327

was found in the expert group.

Page 15 of 26

Choussein 16 328

The inverted pattern observed in the novice-intermediate groups compared to the expert

329

group substantiates previously published work indicating that the performance advantage

330

of robotic technology is more profound for novices than for experts. [6] Re-emergence of

331

handedness among experts in the robotic setting may be reflective of benefit

332

maximization emanating from optimal use of the robotic platform. Once out of the

333

robotic learning curve, both hands still perform better than at conventional laparoscopy,

334

but the dominant hand takes the lead again. Indeed, the dominant hand robotic time of the

335

expert group was the shortest time reported in our study. One could also argue that the

336

intracorporeal suturing task poses a significantly increased level of difficulty to the

337

novice and intermediate-experience groups compared to the expert one, for which may

338

not necessarily comprise an adequately challenging module. It is possible that, had more

339

complex tasks been employed, even experts would have experience a persistent enabling

340

effect of virtual ambidexterity. However, for the purpose of this study, we thought that it

341

was important to limit the comparison to exercises based on a previously validated

342

curriculum, that could be expected to be completed by all three levels of operators.

343

Our study was strengthened by randomizing the order of performance by hand (right or

344

left) and setting (laparoscopic or robotic). This counterbalanced approach controlled for

345

any learning or warming up effects emanating from the completion of the first trial of

346

each session,[15] and likely contributed to the avoidance of a type II error. This was

347

especially important as we found no between-hand difference in the laparoscopic

348

performance of experts. The crossover design of the study,[14] enabled each participant

349

to serve as his or her own control, eliminating the confounding factors of gender, number

350

of cases performed, time since last case, and experience with computer games.[12, 24] Of

Page 16 of 26

Choussein 17 351

note, even within the context of a subgroup analysis of participants with computer game

352

experience, performance patterns remained the same.

353

There are limitations to our study. Although procedure time is considered an acceptable

354

performance metric, it is likely only a proxy indicator of performance, since it does not

355

account for skillful and proper performance. To mitigate this effect, a time penalty was

356

employed where applicable to encourage precise execution. There is published literature

357

where manual dexterity -defined as manual speed and ambidexterity- is measured by

358

utilizing the sums and differences of the right and left hand performance times (only).

359

Based on that, we extrapolated performance time to manual dexterity.[19] Given that the

360

robot-assisted technology is aimed at improving surgical precision and dexterity rather

361

than reducing task time, however, we may have underestimated or failed to reflect the

362

extent of the robotic enabling effect. It is likely that the benefits of robotic assistance will

363

be more profound when the path length and smoothness of task execution are evaluated

364

as well.[25] Also, although the utilized skill drills have been validated to be performed

365

with both hands, they all had be modified to serve the purpose of our study. However, as

366

our study was designed to compare between-hand performance and not laparoscopic and

367

robotic systems nor overall surgical competence per se, implications of these limitations

368

on our conclusions must be insubstantial.

369 370

Conclusion

371

Our study demonstrates that robotic-assistance confers ambidexterity to surgeons in

372

training, compared to conventional laparoscopy. Further investigation is warranted to

Page 17 of 26

Choussein 18 373

define the ultimate clinical value of this particular robotic attribute with respect to actual

374

operative outcomes and patient safety in the surgical learning curve.

375 376

Acknowledgments: The authors would like to thank the staff of the Neil and Elise

377

Wallace STRATUS Center for Medical Simulation at Brigham and Women’s Hospital

378

for their cooperation and overall assistance with study logistics.

379

Page 18 of 26

Choussein 19 380

References

381

1.

382 383

training and evaluation of laparoscopic skills. Am J Surg. 1998;175:482-487. 2.

384 385

3.

Skinner A, Auner G, Meadors M, et al. Ambidexterity in laparoscopic surgical skills training. Stud Health Technol Inform. 2013;184:412-416.

4.

Nutan J. State of the Art Atlas and Textbook of Laparoscopic Suturing. Jaypee Brothers Publishers, 2006.

388 389

Rosser JC, Rosser LE, Savalgi RS. Skill acquisition and assessment for laparoscopic surgery. Arch Surg. 1997;132:200-204.

386 387

Derossis AM, Fried GM, Abrahamowicz M, et al. Development of a model for

5.

Elneel FH, Carter F, Tang B, et al. Extent of innate dexterity and ambidexterity

390

across handedness and gender: Implications for training in laparoscopic

391

surgery. Surg Endosc. 2008;22:31-37.

392

6.

Chandra V, Nehra D, Parent R, et al. A comparison of laparoscopic and robotic

393

assisted suturing performance by experts and novices. Surgery.

394

2010;147:830-839.

395

7.

Mehta S, Dasgupta P, Challacombe BJ. Robotic reconstructive urology:

396

possibilities for the urological surgeon beyond the prostate. BJU Int.

397

2010;106:1247-1248.

398

8.

Moore LJ, Wilson MR, Waine E, et al. Robotic technology results in faster and

399

more robust surgical skill acquisition than traditional laparoscopy. J Robot

400

Surg. 2015;9:67-73.

Page 19 of 26

Choussein 20 401

9.

Culligan P, Gurshumov E, Lewis C, et al. Predictive validity of a training

402

protocol using a robotic surgery simulator. Female Pelvic Med Reconstr Surg.

403

2014;20:48-51.

404

10.

Badalato GM, Shapiro E, Rothberg MB, et al. The da vinci robot system

405

eliminates multispecialty surgical trainees' hand dominance in open and

406

robotic surgical settings. JSLS. 2014;18.

407

11.

innate hand dominance. J Endourol. 2011;25:1385-1388.

408 409

Mucksavage P, Kerbl DC, Lee JY. The da Vinci((R)) Surgical System overcomes

12.

Grantcharov TP, Bardram L, Funch-Jensen P, et al. Impact of hand dominance,

410

gender, and experience with computer games on performance in virtual

411

reality laparoscopy. Surg Endosc. 2003;17:1082-1085.

412

13.

Stefanidis D, Hope WW, Scott DJ. Robotic suturing on the FLS model

413

possesses construct validity, is less physically demanding, and is favored by

414

more surgeons compared with laparoscopy. Surg Endosc. 2011;25:2141-

415

2146.

416

14.

Basic Study Design (Chapter 5). In: Friedman LM, Furberg CT, DeMets DL,

417

Eds. Fundamentals of Clinical Trials. 4th ed. New York: Springer; 2010: 79-

418

80).

419

15.

Repeated Measures Designs. In: Shaughnessy JJ, Zechmeister EB, Zechmeister

420

JS, eds. Research Methods in Psychology. 5th ed. New York: McGraw Hill;

421

2000.

Page 20 of 26

Choussein 21 422

16.

Liebert PS. Surgeons don't have to be ambidextrous. The New York Times:

423

http://www.nytimes.com/1987/02/20/opinion/l-surgeons-don-t-have-to-

424

be-ambidextrous-128587.html (date last accessed: 12/14/15). 1987.

425

17.

Wilder JR. The tyranny of one-handed doctors. The New York Times. :

426

http://www.nytimes.com/1987/02/06/opinion/the-tyranny-of-one-

427

handed-doctors.html?_r=0 (date last accessed: 12/14/15), 1987.

428

18.

surgery. Surg Endosc. 2004;18:790-795.

429 430

19.

431 432

Yang JY, Son YG, Kim TH, et al. Manual Ambidexterity Predicts Robotic Surgical Proficiency. J Laparoendosc Adv Surg Tech A. 2015;25:1009-1018.

20.

Prasad SM, Prasad SM, Maniar HS, et al. Surgical robotics: impact of motion scaling on task performance. J Am Coll Surg. 2004;199:863-868.

433 434

Moorthy K, Munz Y, Dosis A, et al. Dexterity enhancement with robotic

21.

Bocci T, Moretto C, Tognazzi S, et al. How does a surgeon's brain buzz? An

435

EEG coherence study on the interaction between humans and robot. Behav

436

Brain Funct. 2013;9:14.

437

22.

Maniar HS, Council ML, Prasad SM, et al. Comparison of skill training with

438

robotic systems and traditional endoscopy: implications on training and

439

adoption. J Surg Res. 2005;125:23-29.

440

23.

Damiano RJ, Jr., Reichenspurner H, Ducko CT. Robotically assisted endoscopic

441

coronary artery bypass grafting: current state of the art. Adv Card Surg.

442

2000;12:37-57.

443 444

24.

Jenison EL, Gil KM, Lendvay TS, et al. Robotic surgical skills: acquisition, maintenance, and degradation. JSLS. 2012;16:218-228.

Page 21 of 26

Choussein 22 445

25.

Garcia-Ruiz A, Gagner M, Miller JH, et al. Manual vs robotically assisted

446

laparoscopic surgery in the performance of basic manipulation and suturing

447

tasks. Arch Surg. 1998;133:957-961.

448 449 450 451 452

Figure 1. Task 1: Peg transfer (PT) in the (a) robotic and (b) laparoscopic setting.

453

Figure 2. Task 2: Precision cutting (PC) in the (a) robotic and (b) laparoscopic setting.

454

Figure 3. Task 3: Intracorporeal suturing (IS) in the (a) robotic and (b) laparoscopic

455

setting.

456 457

Page 22 of 26

Choussein 23 458

Table 1. Penalty Scoring system TASK Peg transfer

Precision cutting Simple suture with intracorporeal knot

PENALTY Double of average peg transfer time (based on successful transfers only), per each peg dropped 5 sec for every mm of inner or outer circle transected No penalty was applied; task was considered completed when the suture was precisely placed through the two marks and all knots were tied

459 460 461 462

Page 23 of 26

Choussein 24 463

Table 2. Characteristics of study subjects Total Surgical experience, N (%) Gender Female Male Hand dominance Right Left Experience with computer games Yes No Time since last time played <1 yr 1-5 yr >5 yr Among those who play, Mean (SD); hours/week Prior exposure to laparoscopic/robotic technical skills (trainer box/simulatorbased) lab training Yes No Time since last exposure <1 yr >1 yr Cases/week Mean (SD) Weeks since last case Mean (SD)

Novices

Intermediates

Advanced

35

11 (31.4)

12 (34.3)

12 (34.3)

13 (37.1) 22 (62.9)

3 (27.3) 8 (72.6)

8 (66.7) 4 (33.3)

2 (16.7) 10 (83.3)

34 (98.2) 1 (2.9)

11 (100.0) 0 (0.0)

11 (91.7) 1 (8.3)

12 (100.0) 0 (0.0)

15 (42.9) 19 (54.3)

7 (63.6) 4 (36.4)

3 (25.0) 8 (66.8)

5 (41.7) 7 (58.3)

7 (46.7) 2 (13.3) 6 (40.0)

3 (27.3) 2 (18.2) 2 (18.2)

2 (16.7) 0 (0.0) 1 (8.33)

2 (16.7) 0 (0.0) 3 (25.0)

5.3 (9.0)

8.43 (12.15)

3.83 (3.62)

1.00 (0.71)

17(48.6) 17 (48.6)

-11 (100.0)

10 (83.3) 1 (8.3)

7 (58.3) 5 (41.7)

15 (88.2) 2 (11.8)

----

9 (75.0) 1 (8.3)

6 (50.0) 1 (8.3)

2.70 (3.07)

3.73 (2.55)

29.7 (38.5)

0.46 (0.72)

3.3 (2.8) -13.8 (29.3)

464

Page 24 of 26

Choussein 25 465

466 467 468 469 470 471

Table 3. Total performance time using laparoscopic and robotic approaches Non-Dominant Dominant hand, p-value hand, Mean (SD) Mean (SD) Total Lap time, sec

439.4 (244.4)

568.37 (378.2)

0.0008

Total Robotic time, sec

374.43 (229.6)

399.69 (199.3)

0.48

Table 4. Performance time for individual tasks using laparoscopic and robotic approaches Peg transfer

Lap time, sec Robotic time, sec

Dominant hand, Mean (SD)

Non-Dominant hand, Mean (SD)

p-value

46.4 (22.0)

60.2 (33.4)

0.003

48.57 (17.4)

49.03 (22.2)

0.91

Precision cutting

Lap time, sec Robotic time, sec

Dominant hand, Mean (SD)

Non-Dominant hand, Mean (SD)

p-value

190.7 (95.9)

224.43 (135.8)

0.02

145.0 (90.3)

141.57 (57.4)

0.81

Simple suture with intracorporeal knot

Lap time, sec Robotic time, sec

Dominant hand, Mean (SD)

Non-Dominant hand, Mean (SD)

p-value

202.26 (156.7)

283.74 (253.1)

0.01

180.86 (159.2)

209.09 (143.3)

0.33

472 473

Page 25 of 26

Choussein 26 474 475

Table 5. Total performance time using laparoscopic and robotic approaches stratified by level of experience

Group 1 Total Lap time, sec Total Robotic time, sec Group 2 Total Lap time, sec Total Robotic time, sec Group 3 Total Lap time, sec Total Robotic time, sec

Dominant hand, Mean (SD)

NonDominant hand, Mean (SD)

666.0 (196.5)

988.6 (326.1)

609.1 (267.3)

642.6 (164.1)

351.5 (228.7)

437.8 (265.5)

281.9 (110.3)

279.3 (79.8)

319.6 (147.7)

313.7 (93.9)

0.82

251.8 (70.5)

297.3 (75.6)

0.004

p-value

0.01 0.51

0.02 0.92

476 477

Page 26 of 26