Learning Curve of Robotic-Assisted Anastomosis: Shorter than the Laparoscopic Technique? An Educational Study

Learning Curve of Robotic-Assisted Anastomosis: Shorter than the Laparoscopic Technique? An Educational Study

Accepted Manuscript Learning curve of robotic assisted anastomosis: Shorter than the laparoscopic technique? An educational study Benoit Lucereau, MD,...

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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.

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Learning curve of robotic assisted anastomosis: Shorter than the laparoscopic technique? An educational study.

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Benoit LUCEREAU, MD, MSc1, Fabien THAVEAU, MD, PhD1, Anne LEJAY, MD, PhD1,

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Mathieu ROUSSIN, MD1, Yannick GEORG, MD, MSc,1 Frédéric HEIM, PhD2, Jason T LEE,

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MD3, Nabil CHAKFE, MD, PhD1

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1. Department of Vascular Surgery and Kidney Transplantation, University Hospital of

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Strasbourg, Strasbourg, France.

2. Laboratoire de Physique et Mécanique des Textiles, Université de Haute-Alsace,

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Mulhouse, France

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3. Department of Vascular Surgery, Stanford University Medical Center, Stanford, USA

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Corresponding author:

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Fabien THAVEAU, MD, PhD

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Department of Vascular Surgery and Kidney Transplantation,

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Nouvel Hôpital Civil, BP 426, 67091 Strasbourg Cedex, France.

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Tel: (33) 3 69 55 09 27

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Fax: (33) 3 69 55 17 83

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E-mail address: [email protected]

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Original article

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Short title: Learning curve of robotic assisted anastomosis: Shorter than the laparoscopic technique? An educational study.

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Word count:

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Abstract: 270 words

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Article: 2296 words

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ABSTRACT

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Achieving aortic anastomosis in laparoscopic surgery remains a technical challenge. The

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Da Vinci® robot could theoretically counteract this issue by minimizing the technical

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challenge. The aim of this study was to compare the learning curves of performing

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vascular anastomoses by trainees without any experience using purely laparoscopic

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versus robotic-assisted techniques.

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OBJECTIVE

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41 MATERIALS AND METHODS

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Surgery residents were randomly included in the laparoscopic group (group A, n=3) and

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the robotic group (group B, n=3). They performed 10 end-to-end anastomoses on 18-

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mm-diameter tubular e-PTFE grafts. The parameters recorded were duration to

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complete the anastomosis and an indirect sealing quality evaluation (ISQE) defined as

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the following ratio: Nnumber of stitches with a distance of less than 4 mm/Ttotal

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number of stitches.

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RESULTS

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The mean duration to perform the anastomosis decreased from 2340 s (±64) for the

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first anastomosis to 651 s (±248) for the last in group A (p<0.05) and from 1989 s

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(±556) to 801 s (±120) in group B (p<0.05).

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The mean ISQE increased from 74% (±18) for the first anastomosis to 98% (±3) for the

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last in group A (p<0.05) and decreased from 100% to 98% (±2) in group B (NS).

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The mean duration to perform the first anastomosis was lower in group B than in group

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A (p<0.05). The mean duration to perform the last anastomosis was not significantly

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different between the groups.

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Sealing tended to be better in group B for the first anastomosis compared to group A.

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Minimally invasive laparoscopic technique training demonstrates a learning curve to

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perform vascular anastomoses. The robotic-assisted technique tended to improve

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suturing skills and should be considered as a valuable tool to reduce the technical

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learning curve.

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INTRODUCTION

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Among these techniques, laparoscopy was proposed for the surgical care of aortic

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disease but did not have the same popularity as endovascular techniques.

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Dion et al. first proposed and carried out a laparoscopic approach for aortobifemoral

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bypass in 1993 2. Coggia et al. developed the totally laparoscopic technique and

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currently have one of the most important French experiences3 for both occlusive and

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aneurysm aortic diseases. Mid-term and long-term outcomes are similar between

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laparoscopic and open surgery4,5. Despite codified technical and convincing results6,

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there has only been a slight spread of laparoscopy; in 2005, only 195 laparoscopic

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procedures were performed in France out of 24,854 aorto-iliac revascularizations7. The

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emergence and spread of endovascular therapies led to a decrease in open surgery

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indications; thus, the opportunity to learn laparoscopic techniques increased. Unlike

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other specialties within laparoscopic training that start with easy cases, few simple

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surgical procedures are currently available in vascular surgery. Tissue dissection,

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bleeding management, aortic clamping and anastomosis completion in a "closed" space

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are technically challenging for surgeons who have to go through a stage of "re-learning"

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the environment.

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In the early 2000s, a new robotic laparoscopic technique appeared. The Da Vinci robot*

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(Intuitive Surgical, Sunnyvale, CA, USA) has been exponentially developed in general

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surgery, urology and gynaecology because of an easier learning curve than laparoscopy.

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In the field of aortic surgery, a robotic system should make the use of laparoscopy easier,

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particularly in the achievement of vascular sutures.

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Minimally invasive techniques have changed surgical management of vascular patients1.

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Our goal was to determine whether there are differences in learning curves between

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laparoscopic and robotic techniques to complete a safe proximal end-to-end

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anastomosis in the field of minimally invasive aortic surgery.

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MATERIALS AND METHODS

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was set up with three junior trainees (mean age of 26 years) with no experience in

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laparoscopic and open surgery because it was their first year of surgical residency. The

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second group was assigned to the Da Vinci® robot (group B) with three junior trainees

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(mean age of 29 years); two of them were in the third year and one was in the fourth

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year of surgical residency. All of them had prior experience in open surgery, but none

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were experienced in laparoscopy. Ten end-to-end running sutures with a CV-3 Gore-

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Tex® 18-mm needle (WL Gore, Inc., Flagstaff, AZ, USA) anastomosis on an 18-mm-

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diameter GORE-TEX® Stretch vascular graft (WL Gore and associates, Inc, Flagstaff, AZ,

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USA) were to be performed by each resident as evenly as possible. In particular, each

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suture should include equally spaced stitches not farther than 10 mm from the edge of

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the prosthesis. Ten end-to-end anastomoses were performed by each resident as evenly

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as possible. In particular, each suture should include equally spaced stitches that are not

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farther than 10 mm from the edge of the prosthesis. Each surgeon performed two hemi-

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running sutures (posterior and anterior) to complete the anastomosis. Eight half-keys

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were necessary to realize the knot.

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We evaluated two types of criteria:

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-Quantitative criteria: duration to complete the posterior wall anastomosis, the anterior

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wall anastomosis, the knot and the total duration to complete the entire anastomosis.

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The robot was used in the operating room after a surgical procedure as a dry lab, so the

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installation time was not taken into account in the total duration.

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-Qualitative criteria: indirect seal quality evaluation (ISQE) was defined as the following

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ratio: Nnumber of stitches with a distance less than 4 mm/ Ttotal number of stitches).

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All broken CV3 Gore-Tex® sutures were recorded by the robot and pelvic trainer.

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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

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curves of the completion of the posterior and anterior wall knots and the overall

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anastomosis, first in each group and then between groups, we performed a linear mixed

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model, including a "group" effect (group A and B), a "time" effect (anastomosis 1-10), a

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"subjects" effect, and an interaction between "group" and "time". The "subjects" effect is

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a random effect.

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The statistical tests of interest were as follows:

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- Time, which will assess whether the completion speed decreases over time

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- Group, which will assess whether the implementation speed is different from the first

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anastomosis

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- The interaction between "group" and "time", which will assess whether the reduction

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in production time is higher in group A than in group B.

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Significance was defined as p <0.05.

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To evaluate the tightness, the statistical analysis was performed using a Poisson model

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with an offset.

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RESULTS

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30 anastomoses.

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Quantitative Analysis

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In group A, the mean time for completion of the posterior wall decreased from 1321 ±

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75 sec for completion of the first anastomosis to 329 ± 172 sec for the tenth anastomosis

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(p <0.05) (Figure 1). In group B, the mean time for completion of the posterior wall

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decreased from 1087±439 sec for completion of the first anastomosis to 379± 87 sec for

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the tenth anastomosis (p <0.05).

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Upon comparing the results between the two groups, no significant difference was found

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for completion of the posterior wall.

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In group A, the mean time for completion of the anterior wall decreased from 560 ± 165

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sec for completion of the first anastomosis to 254 ± 102 sec for the tenth anastomosis

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(Figure 2) (p <0.05). In group B, the mean time for completion of the anterior wall

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decreased from 739±173 sec for completion of the first anastomosis to 293±76 sec for

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the tenth anastomosis (p <0.05).

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Upon comparing the results between the two groups, no significant difference was found

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for completion of the anterior wall.

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In group A, the mean time for completion of the knot decreased from 458 ± 169 sec for

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completion of the first anastomosis to 65 ± 9 sec for the tenth anastomosis (p <0.05)

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(Figure 3). In group B, the mean time for completion of the knot decreased from 161±36

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sec for completion of the first anastomosis to 129±35 sec for the tenth anastomosis (p

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<0.05).

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Group A made 29 anastomoses (one per procedure withdrawal), and Group B performed

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Upon comparing the results of the two groups, a significant (p<0.05) difference was

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found on the first anastomosis in favour of group B and in favour of group A on the tenth

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anastomosis.

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in 651 s (± 248) (Figure 4) (p <0.05); group B made its first anastomosis in 1989 s (±

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556) and the tenth anastomosis 801 s (± 120) (p <0.05).

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Comparing the results of the two groups, the total time to complete the anastomosis was

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significantly shorter in group B than in group A for the first anastomosis (p<0,05).

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Qualitative Analysis

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In groups A and B, all sutures were performed with regularity; no stitches had a width of up to 10 mm.

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In group A, the ISQE increased from 74±18% (first anastomosis) to 98±3% (tenth

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anastomosis) (Figure 5). There was no significant difference between the first and tenth

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anastomosis. In group B, the ISQE in the first anastomosis was 100% (± 0) and 98% (±

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2) in the tenth anastomosis. There was no significant difference demonstrated between

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the first seal and the tenth anastomosis.

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Upon comparing the ISQE between each group, no significant difference was found.

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Nevertheless, there was a trend in favour of group B for the first anastomoses.

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In group A, there was no yarn breakage during the study. In group B, on the first

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anastomosis, three CV3 Gore-Tex® sutures ruptured, two on the second and one on the

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third anastomosis. Then, no breakage was observed.

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DISCUSSION

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learning these new technical skills explains the low expansion rate of this surgery.

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Laparoscopy creates a closed space in 2-D vision, reversed management, no ergonomic

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position, dissociation between eye-hand coordination and reduced instrument

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movement degrees. Robot technology should compensate for these constraints and help

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surgeons overcome difficulties with the laparoscopic technique. Urologists and digestive

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surgeons investigated the difference in the learning curve between robotics and

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laparoscopy

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Similarly, for minimally invasive surgery for aortic anastomosis (which appears to be

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the main technical difficulty

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facilitation. However, for completion of an anastomosis with the robot and laparoscopy,

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Nio et al. showed that the robot does not decrease the learning curve. We believe that

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we used a more sophisticated robot, offering more degrees of freedom and better vision

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than AESOP 13.

we believe that the robot provides technical

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Minimally invasive techniques have changed the face of open surgery. However,

Yohannes et al. described a large performance improvement with training on the

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robot 8. After comparing different suture exercises and dexterity on the robot and pelvic

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trainer, they observed a learning curve in laparoscopic and robotic methods, but the

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learning curve was faster on the robot with inexperienced surgeons. According to these

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results, in our study considering the total time for residents to complete the first

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anastomosis, learning with the robot is faster than learning the laparoscopic technique.

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In both groups, we observed a significant decrease in completion time of each

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part of the anastomoses despite a low number of junior trainees. Nevertheless, we did

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not find any differences between the two groups for anterior and posterior wall

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suturing. However, with the total anastomosis time, the robotic technique offers faster

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handling than laparoscopy. In a prospective study of 34 students, Stefanidis et al.

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demonstrated that the robot had a faster learning curve than laparoscopy7 9 when using

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a porcine Nissen fundoplication model. At the end of the exercise, junior trainees had to perform a knot, which is

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technically challenging because it requires all degrees of freedom to reproduce human

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hand movement in addition to surgical experience. In our study, the seven degrees of

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freedom of the robot allowed group B to complete the knot more quickly (The difference

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observed on the tenth anastomosis can be explained by the statistical analysis; we

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compared the slope of the curve, and it is higher with the laparoscopic technique). In a

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prospective study comparing laparoscopy and robotics, Chandra et al. demonstrated

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that novice surgeons performed complex tasks such as knots better with robotics than

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with the laparoscopic technique 10.

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ISQE is a ratio developed to objectively determine the quality of an anastomosis.

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It was defined after an in vitro test. End-to-end anastomoses with different gaps

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between stitches (3, 4 and 5 mm) were subjected to a flow of water under pressure.

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Sealing was obtained with points that were less than 4 mm apart. Even with the absence

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of scientific value, this ratio has allowed us to observe an increase in the regularity of

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anastomoses, a decrease in the number of broken CV3 Gore-Tex® sutures and, indirectly,

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an objective learning curve. Moreover, even if there was no difference in terms of sealing

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between the two groups, the robot seems to be easier at the beginning in order to

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achieve a quicker waterproof anastomosis.

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The easier needle-driver manipulation, needle position anticipation, and learning

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hand-eye dissociation and dexterity allowed this improvement in each group. Freedom

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of the robotic instruments, 3-D vision and the lack of tremors improved the learning

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curve of group B. The robot does not offer force feedback. We observed suture breakage

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on the first anastomosis (not affecting anastomosis completion time). However, by the

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fourth anastomosis, the operators were able to compensate for this lack of force

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feedback by sight and habit. The choice of an in vitro end-to-end anastomosis is based on our own surgical

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experience. Although the literature does not demonstrate the superiority of a technique

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(end-to-end or end-to-side), these anastomoses seem to offer better hemodynamic

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results and a reduction in false aneurysms14,15. Because we perform most of our

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proximal anastomoses in end-to end mode, in cases of occlusive disease or aneurysms,

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our choice for the model was this suture technique.

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Several limiting factors were observed in this study. Even with a small number of

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junior trainees in both groups, the number of anastomoses performed was enough to

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achieve a statistically significant evaluation of both techniques. Although the number of

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anastomoses per participant was sufficient to observe a learning curve, extending this

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study to increase the number of junior trainees and include a group of senior trainees

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may be interesting and valuable.

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One of the challenges of this new model was to objectively assess the

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anastomoses. For this purpose, we selected surgeons without technical knowledge that

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allowed us to avoid the apprehension of senior surgeons in using this technique.

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Contrary to our original assumption, the learning curve of the robotic surgical

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anastomosis was fast in spite of the inexperience of the residents. Dexterity quickly

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obtained with the robotic technique counterbalances the apprehension of the machine.

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We chose to evaluate two criteria that seem relevant to the study: quantitative

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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

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develop a score that will allow us to evaluate the evolution of residents and create a

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threshold that would allow them to perform the procedure in vivo. Simulation therefore

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enables development of skills in order to improve surgical performance 16. Currently, all

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of our residents use this model to assess their progress and practice the techniques.

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Furthermore, with the increasing availability of the robot, this model is easy to

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reproduce in a training centre, enabling a diffusion model.

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CONCLUSION

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to be quicker than that of laparoscopic surgery. Compared to laparoscopy, the robot

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allowed faster, more accurate and easier learning of technical skills on the first

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anastomoses. Robotics may offers the opportunity for surgeons to more quickly acquire

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skills to perform a technique that is deemed difficult and, therefore, may provide better

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reproducibility.

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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

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Associate, Inc.

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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.

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Figure 5: Evolution of ISQE in group A and B.

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Figure 4: Evolution of the total time completion of anastomoses for group A and group B.

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