Reprints of: Robotic colorectal surgery: Evolution and future

Accepted Manuscript

Reprints of: Robotic colorectal surgery: Evolution and future Evan Weitman MD , Mona Saleh , Jacques Marescaux MD , Terri R. Martin MD , Garth H. Ballantyne MD PII: DOI: Reference:

S1043-1489(18)30062-9 https://doi.org/10.1053/j.scrs.2018.11.013 YSCRS 658

To appear in:

Seminars in Colon & Rectal Surgery

Please cite this article as: Evan Weitman MD , Mona Saleh , Jacques Marescaux MD , Terri R. Martin MD , Garth H. Ballantyne MD , Reprints of: Robotic colorectal surgery: Evolution and future, Seminars in Colon & Rectal Surgery (2016), doi: https://doi.org/10.1053/j.scrs.2018.11.013

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ACCEPTED MANUSCRIPT Seminars in Colon and Rectal Surgery 27 (2016) 121–129

Contents lists available at ScienceDirect

Seminars in Colon and Rectal Surgery journal homepage: www.elsevier.com/locate/yscrs

Robotic colorectal surgery: Evolution and future

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Evan Weitman, MDa, Mona Saleha, Jacques Marescaux, MDb, Terri R. Martin, MDa, Garth H. Ballantyne, MDa,n a

Department of General Surgery, New York Medicine School of Medicine, New York, NY 10010 Research Institute Against Cancer of the Digestive System (IRCAD), European Institute of Telesurgery (EITS) and International Institute for Omage-Guided Surgery HIU), Strasbourg, France

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The introduction of laparoscopic cholecystectomy changed the approach to abdominal surgery revealing the patient-specific advantages of minimally invasive approaches to gastrointestinal diseases. Unfortunately, inherent limitations of laparoscopy impeded widespread utilization of laparoscopic surgery in advanced procedures such as laparoscopic colectomy. Even as prospective and randomized trials demonstrated outcomes advantages for the patient, few surgeons introduced laparoscopic colectomy into their practice. Robotic surgery has offered solutions to these inherent limitations of laparoscopic surgery. Yulan Wang and Computer Motion introduced the first FDA approved robotic surgery assistant, AESOP. This robot responded to foot controls and subsequently oral commands providing tremor free reliable video-laparoscopic camera control. As video-laparoscopic colorectal surgery evolved, Colorectal Surgeons were plagued with the intrinsic limitations of laparoscopic surgery, such as motion reversal and motion amplification of the surgical instruments caused by the fulcrum effect of the abdominal wall trocar. Using Department of Defense grants and venture capital funding, two surgical technology companies, Computer Motion and Intuitive Surgery developed robotic surgical systems to overcome these limitations, Zeus and da Vinci, respectively. Although these robotic surgical systems were intended to perform remote battle-field surgery with the surgeon stationed on an aircraft carrier or remote MASH Hospital, state licensing issues and malpractice concerns prompted both companies to focus on surgery with the patient, surgeon and robot in the same operating room. Zeus gained FDA approval first and Da Vinci followed shortly after. Eventually patent conundrums proved only solvable by Intuitive buying out Computer Motion leading to a consolidation of the technology from both companies into the subsequent generations of Da Vinci. More recently, as Intuitive's patents begin to expire, new robotic surgery companies are entering the market with surgical robots targeting specific niches in the future robotic surgery market. In particular, MedRobotics, for example, will soon introduce a surgical robot given FDA approval for transanal resections of neoplastic lesions. Similarly, Titan will enter the market with a surgical robot at a substantially lower price-point that the da Vinci. Clearly, surgical robotic options for colorectal patients will continue to expand in the near future. The long-term use of these technologies, of course, will require a long period of prospective and randomized clinical trials. Published by Elsevier Inc.

The evolution of robotic surgery The advent of laparoscopic surgery—Laparoscopic cholecystectomy In 1901, the first laparoscopic surgery was performed on a dog by Georg Kelling in Hamburg, Germany.1 Kelling used the Nitze

Disclosures: The authors have no conflict of interests in writing this article. None of the authors own stock, act as consultants, receive honoraria or any other type of financial support from any company related to this article. n Corresponding author. E-mail address: [email protected] (G.H. Ballantyne). http://dx.doi.org/10.1053/j.scrs.2016.04.002 1043-1489/Published by Elsevier Inc.

cystoscope for visualization of the peritoneal cavity. Almost a decade later, Kelling and others performed the first laparoscopic surgeries on human patients; however, the technology was significantly limited by poor visualization. In 1985, the field of laparoscopy was revolutionized by the introduction of the charge couple device (CCD) camera, which allowed for projection of the image onto a video monitor substantially improving visualization of the operative field. Erich Muhe utilized this new innovation to perform the first laparoscopic cholecystectomy in 1985 and was shortly thereafter followed by Philippe Mouret in France in 1987.2,3 In the United States, Reddick and Olsen4 developed the techniques generally used subsequently by American Surgeons and opened

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the first laparoscopic training center for General Surgeons in Marietta, GA.

Early experience with laparoscopic colectomy

Motion amplification The fulcrum effect of the trocars also adds an additional hindrance to surgical technique. Typically, about two-third of the laparoscopic surgical instrument is within the abdomen and about one-third outside. As a result, a 1-in downward motion of the instrument handle in this case generates a 2-in upward deflection of the instrument's tip. Similarly, this fulcrum effect amplifies any resting tremor present in the surgeon's hands. This motion amplification also contributed in the reluctance of surgeons to perform advanced laparoscopic operations. Parallel instruments The trocars add still an additional limitation in the use of the laparoscopic instruments. Because the trocars are fixed in place, they limit the mobility of the laparoscopic instruments. Ergonomics for the laparoscopic instruments require that the two working instruments approach either other at near a right angle. And about 451 above the horizon. Since the trocars cannot move, two laparoscopic instruments only meet at or near these angles in a small sphere within the abdomen. In laparoscopic cholecystectomy this is only a minimal nuisance since the trocars can be positioned such that this ideal sphere of function can readily be centered around the structures of Calot's triangle. When doing a colectomy which involves dissection throughout half of the abdomen or more, the two instruments spend significant periods of time outside of this sphere of ideal performance and are often nearly parallel making cutting, tying, and dissection difficult.

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Jacobs et al.5 published the first Laparoscopic Right Colectomy in 1991. They predicted: “Although laparoscope-assisted colonic surgery may still be considered a procedure in evolution, we feel that in time it has the potential to be as popular as laparoscopic cholecystectomy.” Shortly after this, Dennis Fowler accomplished the first laparoscopic left colectomy using a proto-type of the Endo-GIA developed by the United States Surgical Corporation.6 Early series of laparoscopic colectomy suggested that a laparoscopic approach to colorectal operations would offer specific benefits to patients in terms of short-term clinical outcomes. Our early series of our first 50 laparoscopic colectomies at the West Haven Veterans Health Administration Medical Center indicated that laparoscopic colectomy decreased operative blood loss, decreased post-operative pain as measured by narcotics use, and shortened hospital length of stay compared to open operations.7 We also demonstrated in a subsequent article that cardiovascular function during laparoscopic colectomy was improved by the mild acidosis associated with the carbon dioxide pneumoperitoneum and the frequent use of the Trendelenberg position.8 Subsequent, prospective and randomized trials supported these conclusions and also found that patients returned to a normal quality of life more rapidly.9,10 Long-term follow-up of colonic cancer patients randomized between laparoscopic and open cancer resections did not show a worse outcome for patients treated with laparoscopic operations.11 Despite the apparent advantages of minimally invasive approaches to colorectal diseases, few colon, and rectal surgeons embraced Laparoscopic Colectomy or introduced it into their clinical practice.

Motion reversal As mentioned above, the laparoscopic trocars through which surgical instruments are introduced during laparoscopic operations act as a fulcrum and reverse the motions of the instruments (Ballantyne). As a result, movement of the instrument handle down causes the tip of the instrument to move up. Many surgeons found this paradoxical motion difficult to overcome and increased their reluctance to adopt laparoscopic colorectal surgery.

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The inherent limitations of laparoscopic colectomy

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Despite the patient-specific outcome advantages of minimally invasive colectomy, few surgeons introduced Laparoscopic Colectomy into their practice. The increased complexity of colectomy compared to cholecystectomy, amplified the practical problems of laparoscopic techniques making the learning curve for laparoscopic colectomy long and steep.12–14

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Two-dimensional imaging The CCD camera, instrumental in accelerating the adoption of Laparoscopy Cholecystectomy because of its better visualization ultimately limited adoption of Laparoscopic Colectomy. The laparoscopic video image is two dimensional. Many surgeons are hesitant to approach the complex anatomy of colorectal operations relying only on a two-dimensional image. Although the surgeon can learn to compensate for the loss of binocular vision through depth cues such as lighting, known size of objects in relation to one another and texture gradients, many were reluctant to learn these new skills and to subject their patients to prolonged operations during their learning curve.15 Studies by Birkett16 documented the increased stress and tension experienced by surgeons when using two-dimensional video images to perform complex tasks such as laparoscopic operations. Humans evolved dependent on binocular stereoscopic vision. Although the cerebral cortex can perceive three dimensions from two-dimensional images, it requires excessive “processing time” leading to stress, tension and fatigue.16,17

Ergonomics There is a growing literature regarding orthopedic injuries sustained by laparoscopic surgeons, because of the ergonomically incorrect postures they must often assume in performing laparoscopic operations.18,19 Often the laparoscopic surgeon finds himself looking at a monitor in one direction while his instruments are pointed in another. Similarly, the surgeon often must elevate his hands and shoulders because of the length of the instruments. All of these unnatural motions lead to muscle fatigue and often orthopedic injuries. Loss of proprioception In open operations, surgeons use a full array of senses to discern and understand the three-dimensional anatomy and pathology on which they are operating. As mentioned above, surgeons loose three-dimensional imaging. In addition, as their hands are no longer within the abdomen, they also loose proprioception, a loss of three-dimensional orientation. One often sees a laparoscopic surgeon struggling to find the location of a newly inserted instrument. Increased motions to accomplish tasks Ara Darzi at Imperial College in London performed motion analysis of simple surgical tasks being performed using open techniques and instruments versus the same tasks being performed laparoscopically and with laparoscopic instruments.20 These studies found that these tasks could be performed with the same degree of precision with either technique but that

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this magnified image originated in the ability of the human camera holder to maintain a steady hold of the camera and to anticipate where the surgeon next wanted to look. As a result, it soon became apparent that the projected laparoscopic image was subject to the camera-holder's motion, attention and endurance. In cases where the camera holder has significantly less training than the operative surgeon, the case is often lengthened due to frequent redirection by surgeon. Yulun Wang and Computer Motion, Inc., addressed this problem with the first FDA approved surgical robot in the United States. Computer Motion's innovative robotic arm for holding the video scope, known as Automated Endoscopic System for Optimal Positioning (AESOP), was introduced into clinical trials in 1993. The technology for AESOP was originally designed by Wang with a NASA grant for the US space program and its adaptation to a camera holder was later approved for surgery by the FDA in 1994. The initial version of AESOP was controlled by the surgeon via a foot switch or hand control. Subsequent versions of AESOP utilized voice activation.23 AESOP was demonstrated as an effective tool in solo-surgeon laparoscopic colectomy.24 However, AESOP had its own limitations. The voice feedback required for AESOP camera movement was slower than an experienced camera driver. To address this, computer motion developed a head tracking system by which the surgeon could re-direct the view of the camera through eye motions.25 Surgeons using AESOP overcame this limitation by often attempting to complete dissection in a single visual field before moving the camera to another visual field. AESOP became the modular building block for computer motions robotic surgery platform, Zeus.

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Fig. 1. Michele Gagner, MD sitting at an early prototype of the Zeus surgeon's console suturing a mammary artery to coronary artery bypass anastomosis in a pig. Moji Ghodoussi, a computer motion engineer, sits by his right hand and Nick Smedira, cardiac surgeon at the Cleveland, sits near his left hand @ 1995 (photograph courtesy of Michele Gagner, MD).

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performing the tasks laparoscopically required significantly more motion and time. In terms of time and motion, traditional open surgery is more efficient than laparoscopic techniques.

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Hand-assisted laparoscopic colectomy as a partial solution to the tactile limitations of laparoscopic colectomy Laparoscopy allows for a less invasive approach to colectomy, which provides specific outcome advantages such as less pain, less blood loss, and shorter hospital lengths of stay. Yet, as described above, standard laparoscopic techniques also diminish the surgeon's sensory experience with regard to three-dimensional imaging and proprioception. Despite the patient-specific outcome advantages documented for laparoscopic colectomy, very few surgeons incorporated laparoscopic colectomy into their practice. In laparoscopic colectomy, an incision is ultimately made for extraction of the resected segment of colon. Ballantyne and Leahy21reasoned that since this incision was mandated for specimen extraction why not use it to introduce a hand into the abdomen to facilitate dissection, enhance tactile feedback and re-introduce proprioception for the surgeon in a “hand-assisted” laparoscopic colectomy. To this end, Leahy developed and patented Dexterity, a sleeve-like device that served to maintain the pneumoperitoneum while the surgeon introduced his hand into the abdomen, which was secured in the wound with a wound protector. The senior author performed the first hand-assisted colectomies with this device. Subsequently, this device was marketed under the name Handport. In 2000, the hand-assisted laparoscopic surgery (HALS) described outcomes from 68 consecutive operations.22 Litwin and colleagues argued that handassisted laparoscopic colectomy provided several distinct advantages over pure laparoscopy, including better ability to retract and explore as well as the ability to apply immediate hemostasis when necessary. Although hand-assisted techniques facilitate performance of minimally invasive colectomy, market penetration in the United States remained poor. Surgeons still found Laparoscopic Colectomy too difficult to perform on a routine basis. AESOP: First use of robotics to address the limitations of laparoscopic colectomy Minimally invasive surgery expanded rapidly with the visualization provided by the CCD camera. A problem encountered with

ZEUS: Tele-robotic surgery with three robotic AESOP arms Computer motion developed a robotic surgery platform using three AESOP's as modules (Fig. 1).26,27 The one AESOP arm held the voice-controlled camera and two modified AESOPs held the robotic—laparoscopic instruments. The surgeon controlled the motion of the robotic arms from a console that could be placed in the operating room or remotely anywhere in the world.28 Michele Gagner worked with early Zeus prototypes validating the dexterity required for appropriate surgical precision (see photograph). This concept of telerobotic surgery with the surgeon in one location and the patient in another was validated both by Marescaux and Anvari using a Zeus. The limitation of telerobotic surgery between remote locations resides is the speed of light and the speed at which the surgeon's console communicates back and forth with the remote surgical robot. The surgical console sends a signal to the remote robot that it should move the camera or an instrument. The remote robot performs the task and sends back the video image and a systems update to the surgeon's console. The surgeon is visually updated as to the robot's remote actions with the video image. As the console is removed further and further from the surgical robot, the time interval between the action by the surgeon, the implantation of the action and the return of the video signal increases. The maximum delay time for this complete cycle deemed safe based on experimental trials was about 300 ms. Marescaux et al.29 performed the first transcontinental laparoscopic cholecystectomy on a patient at Mount Sinai Medical Center in New York City from the IRCAD in Strasbourg, France.30,31 This operation was successfully performed with a latency of 150 ms using a dedicated trans-Atlantic fiber optic cable. Similarly, Anvari et al.32 performed operations on a regular basis in a remote hospital in northern Canada from his hospital in Ontario, Canada. Again, a dedicated fiber-optic cable was used to connect the console to the remote surgical robot.

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Department of defense and robotics for remote battle-field surgery The department of defense has supported with grants the development of telerobotic surgery in order to facilitate remote battlefield surgery.33 This issue of latency proves the current limitation of implementing life saving robotic operations on the battle-field. The initial solution was to pass the signals back and forth via geosynchronous satellites.34 The latency of the signal transit time back forth proved beyond the 500 ms cut off for mistake free surgery. Even a 250 ms delay in data transmission significantly increases the time surgeons require to standard surgical tasks.35 A more workable system proved to be bouncing the signal off an unmanned aerial vehicle. The master (surgeon's console) signals made the round trip circuit to the robot (slave) and back within 20 ms and the video signal within 200 ms.36 Subsequently, computer motion developed another approach that remains promising, using the Internet. Interestingly, the latency of transmission of the Internet varies little with the distance between Internet connections and would permit safe remote surgery via the Internet.

Robotic surgery as a solution to the inherent limitations of laparoscopic colectomy The inherent limitations of two-dimensional video–laparoscopic surgery, the fulcrum effect of the trocars and the poor ergonomics detailed above add to the difficulty of performing operations such as minimally invasive colectomies.40 Robotic surgery offers solutions to many of these problems, offering advantages such as a stable camera platform that does not require a human to hold, surgical instruments with up to seven degrees of freedom, no motion reversal and no motion amplification. In colectomy, generally, the increased freedom of movement of telerobotic instruments (as a result of tip-to-tip control inherent to da Vinci) allow for an easier dissection. Another distinct advantage of the Xi da Vinci four-arm robotic surgery system is the ability for a surgeon to operate with minimal assistance. Initial experience with robotic colectomy

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The genesis of da Vinci Many current telerobotic surgery concepts were developed with financial assistance from the US Department of Defense, which hoped that such technology would allow surgeons in a remote, secure locations to operate on military personnel wounded in the battle-field, since the vast majority of soldiers die before reaching a medical facility.37 Himpens and Cadierre performed the first human operation with a prototype of the da Vinci in 1997, a robot-assisted cholecystectomy (Fig. 2). Using master (surgeon)/slave (robot) software, the da Vinci (Intuitive Surgical) Si Robotic Surgery System with three robotic arms was approved by the FDA in 2000.38 The da Vinci utilizes hand controls and five foot pedals to control various aspects of surgical practice including camera focus and disengagement and positioning of instruments. Motion scaling is surgeon controlled with this system, down to 5:1 scaling facilitating micro-surgery. The da Vinci also filters out surgeon resting tremors using fast fourier transforms (FFTs). In 2002, a fourth robotic arm was FDA approved for the da Vinci and often acts as a retractor that the surgeon may reposition as needed. Seemingly the most important aspect of the da Vinci system is the ability to perform “telepresence surgery.”39 Here, as the surgeon looks into the binoculars in the control console, the surgeon is inserted “into” the patient in the three-dimensional operative

field. It is this component of the da Vinci system that allows one to conceive of its use in the battlefield. More recently, Intuitive has introduced the Xi platform, which facilitates initial coupling of the robot to the laparoscopic trocars and increased access to multiple quadrants of the abdomen without re-docking the robot.

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Fig. 2. Jacques Himpens and Guy Bernard Cardierre performing the first robotic human operation with a da Vinci prototype, a robotic cholecystectomy, in 1997 (photograph courtesy of Jacques Himpens, MD).

Lateral to medial dissection Ballantyne performed the first robot colectomy in November, 2000, using a three arm Si da Vinci duplicating his standard lateral to medial laparoscopic colectomy technique.41 Initial experience in Hackensack, New Jersey, with the Si da Vinci for 12 robotic colectomies using a lateral to medial dissections demonstrated that robotic colectomy could be performed safely with outcomes at least similar to standard laparoscopic colectomy. Nonetheless, the mechanics of the robotic system made the lateral to medial dissection cumbersome because of the gearing ratios of the robotic arm. Rotation of the cecum medially and cephalad required multiple re-settings of the hand controls of the retracting robotic instrument.42 Medial to lateral dissection proved a more efficient approach. Initial experience with robotic colectomy Medial to lateral dissection Jeff Milsom initially developed the medial to lateral approach for laparoscopic colectomy when he moved to the Cleveland Clinic. Victor Fazio, Chief of Colon & Rectal Surgery at the Cleveland Clinic, challenged Milsom to duplicate laparoscopically the No Touch Technique for colectomies developed by Turnbull at the Cleveland Clinic.43 Milsom et al.44 successfully developed this technique making it his standard approach for laparoscopic colectomy.45 Many other surgeons adopted this approach around the world. Piero Giulianotti was one of the first surgeons performing robotic surgery operations and established the first European Robotic Surgery Training Center in Grossetto, Italy. At his courses, D'Annibale et al.46 routinely performed robotic medial to lateral dissections as their technique of choice for robotic colectomy. With the assistance of Alessio Pigazzi, who had trained in General Surgery with Milsom at Cornell in New York City, Ballantyne adopted the medial to lateral approach and subsequently made this the basis of instruction for robotic colectomy at the Intuitive Surgical Northeastern American Training Center at Hackensack University Medical Center Retrospective comparison of these two robotic techniques at Hackensack disclosed no significant difference in patient outcomes between the two groups, including in total OR time, surgical time, mortality, morbidity, number of lymph nodes harvested, and post-operative length of

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Fig. 3. Ballantyne performing first reported da Vinci single incision laparoscopic surgery (SILS) right hemicolectomy through the upper abdominal mid-line extraction site on 3 March 2009. Ballantyne using the Si three-armed da Vinci performed a medial to lateral dissection.

Fig. 4. Intuitive surgical single port system (SPL) uses the distal articulation of the instruments and camera to overcome the problems of co-axial orientation and to gain mechanical advantage for surgical tasks. In addition, the shaft of the system offers extreme flexibility and rigidity when required (photograph courtesy of Intuitive Surgical, Inc.).

laparoscopic instruments. More recently, in 2013, Morelli et al.52 in Pisa, Italy, reported performing a single incision robotic right colectomy using the da Vinci single-site platform (Fig. 4).

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surgery.38 Additional studies by Pigazzi et al.47 at the City of Hope added support to the safety of this approach.

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Robotic single incision right hemi-colectomy In 2008, Cleveland Clinic performed the first single incision/ single port laparoscopic right hemi-colectomy for removal of an unresectable cecal polyp on an obese woman.48 As previously utilized for hand-assisted laparoscopic colectomy, the mandatory specimen extraction site for colectomies offers a gateway for single incision laparoscopic operations typically a 3–5 in vertical incision at the umbilicus. The pneumoperitoneum is maintained with commercially available wound ports, such as Gel Port, through which the trocars are inserted. The limitation of this technique is the close placement of neighboring trocars, which forces the laparoscopic instruments to be parallel. As discussed above, when parallel, the instruments lose their mechanical advantage making usually simple surgical tasks such as dissection or knot tying very difficult. The da Vinci offered a solution to this problem thereby facilitating single-incision minimally invasive colectomy. At Hackensack University Medical center, Sommer et al.49 accomplished the first robotic single incision right hemicolectomy on 3 March 2009 (Fig. 3). About the same time, DeNoto at North Shore-Long island Jewish Hospital performed a series of three Single Incision Robotic Colectomies.50 We used a Gel Port handaccess system in a 5 cm supra-umbilical midline incision. We accomplished the medial to lateral robotic right hemicolectomy using three trocars inserted through the Gel Port. The articulation of the da Vinci instruments utilizing their seven degrees of movement overcame most of the issues caused by the close placement of the three trocars. An additional feature of the da Vinci further improved the mechanical advantage of the instruments. The da Vinci surgeon's console permits reassigning of the surgical instruments to the two hand controls. By crossing the instruments near the level of the abdominal wall further separation of the instrument tips was gained.51 The surgeon used the right hand controls to activate the left instrument and the left hand controls to operate the right instruments. In the three-dimensional video image, the surgeon appeared to control the instrument in the right side of the video image with his right hand and the instrument in the left side of the image with his left hand. The combination of the seven degrees of freedom for motion of the instrument tips and the separation of the instrument tips by crossing the shafts greatly facilitated the dissection. This technique cannot be duplicated with

Hospital credentialing and privileging for robotic surgery

The introduction of laparoscopic cholecystectomy into clinical practice precipitated a re-examination by American surgery of how new surgical techniques and operations should be introduced into clinical practice. Under the guidance of Kenneth Forde from Columbia Presbyterian Medical Center, New York State Department of Health took the lead in setting specific standards.53 In an official memorandum, the New York State Department of Health wrote that in order to gain hospital privileges to perform laparoscopic cholecystectomy, the surgeon must demonstrate: (1) Certification (or eligibility) by the American Board of Surgery, (2) credentialing in open cholecystectomy, common bile duct exploration, and liver procedures, (3) completion of a “practicum” with elements of didactic course work, inanimate laboratory, animal laboratory, objective testing, and certification, (4) assistance at laparoscopic surgery (minimum of 5–10 procedures), and (5) a form of proctoring (performance under direct supervision of a surgeon already privileged) (minimum number: 10–15 procedures).54 These recommendations were widely adopted by various national surgical societies. As a result, recommendations similar to these were endorsed by various surgical societies such as Society of American Gastrointestinal Endoscopic Surgeons (SAGES) and adopted by most hospitals in the United States for laparoscopic cholecystectomy.55 These types of credentialing and privileging criteria were also widely applied to other new surgical techniques, including robotic surgery, as they were introduced into clinical practice.56,57 Tele-preceptoring and tele-proctoring These credentialing and privileging requirements introduced a new concept of preceptoring and proctoring surgeons in their early experience with new surgical operations, techniques and technology. At some institutions, these requirements for preceptoring and proctoring presented a challenge because there were few experts in advanced laparoscopic and robotic operations. Indeed, bringing in outside experts from other institutions to preceptor and to proctors proved expensive for the hosting institution and time

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Robotic natural orifice transluminal endoscopic surgery (NOTES)

The Titan SPORT A more cost-effective robotic surgery platform? Titan Medical Inc. is currently moving towards their first patient trials using the single port orifice robotic technology

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consuming for the invited expert. Nonetheless, onsite preceptoring may decrease complications during the initial experience with a new technology or surgical technique. Sgambati and Ballantyne58 preceptored the initial experience of—surgeons with laparoscopic colectomy without significant complications. Yulun Wang, first at Computer Motion and subsequently at Intouch Health, developed technological solutions that permitted the expert surgeon to preceptor or proctor the novice surgeon from a remote location, usually their own hospital. Computer motion utilized the telepresence systems of Zeus that enabled remote separation of the surgeon's console from the surgical robot and patient. Computer Motion called this system Socrates and the FDQA approved its use as a telecollaboration device in 2001.59 This device allowed a telementor to remotely connect to the operating room and share audio and video signals, control camera movements, and annotate anatomy from the remote surgeon's console.35 Kavoussi et al.60 validated this concept of remote teleproctoring in laboratory and clinical operations using a telepresence surgical robot. All operations were completed successfully.60 These technologies and patents transferred to intuitive surgery when intuitive acquired computer motion. Intouch Health collaborated with Storz in designing a telementoring and teleproctoring system as part of the Storz OR1 digitally integrated operating room system. This permitted the expert surgeon to observe remotely the progress of the operation on a lap top computer via the Internet. Both interior and exterior views were available. With this system the expert surgeon could monitor the operation and offer advice, i.e., proctor the operation, but could not over-ride control of the surgical instruments, i.e., preceptor the operation.

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Fig. 5. Titan's single port orifice robotic technology (SPORT) surgical system, which provides three-dimensional imaging and two working surgical instruments with a broad range of motions (photograph courtesy of Titan Medical, Inc.).

Natural orifice transluminal endoscopic surgery (NOTES) is a surgical technique where endoscopes are placed and surgery is performed through natural orifices in the human body. NOTES has been accomplished through the mouth, nose, vagina, or anus allowing surgery to be performed without visible external scars. NOTES has been limited by the technology of available endoscopes. These limitations include the lack of endoscopes that are flexible enough for the required extreme angulations and the limited visualization of the surgical field provided by current endoscopes. These obstacles to NOTES surgery are shared with single port laparoscopy (SPL). Because of the diameter of natural orifices and single ports, traditional laparoscopic instruments and the laparoscope assume very close co-axial orientations. This co-axial alignment makes simple surgical tasks difficult and, often, impossible. For the purposes of overcoming some of the obstacles posed by NOTES and single port laparoscopy, the da Vinci and new surgical robots soon coming to market offer distinct advantages. The distal articulations and seven degrees of freedom for motion of the da Vinci surgical instruments overcome the limitations of co-axial alignment. A recent five-patient experience combined the da Vinci robot (intuitive surgery) with NOTES to perform transvaginal NOTES hysterectomy and demonstrated feasibility in gynecologic surgeries. Nonetheless, da Vinci was not specifically designed for NOTES or SPL.61 Newer surgical robots designed specifically for the challenges of single incision port (SPL) surgery may further facilitate these procedures. There are at least 12 new robotic systems being developed for single port laparoscopy (SPL). These robotic platforms have demonstrated enhanced dexterity and feasibility in animal models.62–64 The MedoRobotics Flex system (Fig. 5) shows many of the features of this new class of surgical robots. In each, a camera and two laparoscopic instruments pass out of the end of the endoscope-like system in a manner very similar to the channels of an endoscope. In these systems, however, the camera and instruments flex away from each other gaining mechanical advantage (Fig. 5).

The future of robotic surgery The future of robotic surgery will be shaped by the introduction of new robotic surgical platforms and the evolution of computerbased surgical technologies. New robotic surgery platforms are poised for release into the American market in the immediate future. Several new robotic systems have already gained FDA approval and will likely enter the American market in the immediate future. Future systems under development with merge computer-based technologies to improve surgical simulation and to commence an era of augmented reality surgery.

Fig. 6. Combined imaging superimposing three-dimensional reconstructions of patient-specific digital data from CT scans or ultrasounds onto the three-dimensional da Vinci surgeon's console binocular three-dimensional video image (courtesy of Jacques Marescaux, MD).

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Simulations of robotic surgery for surgical resident training

Augmented reality in robotic surgery In developing the technology for surgical simulation as described above, Marescaux also realized that the da Vinci super computers could herald a new age of augmented reality robotic operations.76 Marescaux and his team have developed first generation augmented reality capabilities. They have been building upon the ground work described above for surgical simulation. In their approach, they use patient-specific, color-coded, anatomical reconstructions developed for their simulations to augment the surgeon's perception of three-dimensional anatomy and anatomical structures during the operation. In this system, the threedimensional, color-coded reconstruction of the patient-specific anatomy is projected onto the three dimensional binocular, three-dimensional operative visual field (Fig. 7).77 As the surgeon looks at the hepato-duodenal ligament, for example, the three dimensional reconstruction is super-imposed on the binocular video image revealing, before dissection commences, exactly the location and course of the common bile duct, common hepatic ducts, cystic duct reside and hepatic arterial and venous circulation. Gill and colleagues have also been developing techniques of imposing geometrically correct images on the laparoscopic image. Although only in its infancy, surgical simulation and augmented reality surgery significantly add precision in identification of anatomy in safe dissection.78 Augmented reality systems will advance rapidly because of its importance to the American Mars Mission.

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Surgical residents have always spent a great deal of time practicing knot tying. More recently video simulations permit surgery residents to practice their laparoscopic surgery skills using a laparoscopic surgery simulation device. Indeed, surgical residents in the United States must pass the Fundamentals of Laparoscopic Surgery, a set of video games that measure the resident’s level of skill in performing specific surgery tasks, for board certification.67 With the da Vinci, these training simulations have been taken to a new level of sophistication.68 The Mimic dVTrainer comes as an add-on for the Xi da Vinci surgeon’s console. This also provides a variety of games that help the resident master specific surgical skills. In the near future, surgical residents will be required to pass the Fundamentals of Robotic Surgery based on these games for board certification.69 Despite the increasing sophistication of these training simulators, no study has validated clinical skill transfer from the simulator to the patient.70

performing complex procedures and failed to show a significant advantage in performance advantage.

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(SPORT) surgical system (Fig. 6). Sport requires only a 25 mm single-incision yet offers three-dimensional visualization and interactive instruments that will be marketed for minimally invasive abdominal surgical procedures.65 In addition to previously described benefits of minimally invasive surgeries for the patient, Titan states that their technology will provide improved dexterity for the surgeon with multi-articulating instruments as well as an easier and shorter learning curve.66 Moreover, Titan predicts that their surgical robot will enter the market at substantially lower cost than current robotic systems. The expectation is that this will permit the further dissemination of the benefits of minimally invasive robotic surgery to smaller hospitals throughout the United States.

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Simulated operations in robotic surgery

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The da Vinci uses super computers to translate the motion of the surgeon's hands into mechanical motion of the robotic surgical instruments. Marescaux, at the IRCAD in Strasbourg, has pioneered the strategy of using these already present super computers to add surgical simulation and augmented reality to minimally invasive surgery. Based on computer simulated training models for airplane pilots, Satava has proposed that surgeons should perform practice operations for complex procedures on computer generated simulations of the individual patient.71 Marescaux and colleagues have developed augmented reality systems to facilitate this concept. In this strategy, patient-specific digital data from CT scans, MRIs and PET scans are fed into the da Vinci's super computers. From this data, the da Vinci generates three-dimensional simulation of patient-specific anatomy.72 Like airplane pilots practicing landings for the difficult approach to Hong Kong's runaways, the surgeon practices the hepatectomy or pancreatectomy on the computer simulation. The computer color codes the anatomy in a manner similar to anatomy books: arteries are red, veins blue, biliary ducts orange, etc. As aberrant anatomy becomes demonstrated through the practice dissections, the surgeon can adapt their surgical approach for the patient's individual anatomy and pathology. This permits the surgeon to identify anomalies such as an absent cystic duct in the simulation before dissecting Calot's triangle in the patient. In warm up exercises for patient-specific simulated rehearsals of carotid artery stenting, Willaert et al.73 significantly improved operative performance. Similarly, Satava and Urologists at the University of Washington School of Medicine observed significant performance improvement in a group of 51 surgical residents after a virtual reality warm-up for routine surgical tasks.74 In contrast, O'Leary et al.75 evaluated published studies evaluating the effect of physical rehearsal or warm-ups before

The Mars mission and surgical simulation

Long confined to the pages of science fiction, NASA is currently developing a mission to send humans to Mars in the 2030s (NASA's Journey to MARS, https://www.nasa.gov/content/nasas-journeyto-mars, Accessed 23 December, 2015). Because of the young age of the astronauts, the probability of one of the astronauts developing appendicitis or other surgical emergency of young adults is significantly high enough that NASA must plan for this event. Indeed, simulated appendectomies with surgeon and patient separated by substantial distances have been the basis of training exercises using a remote base in the Artic.79 The cost of sending a surgeon to Mars, who would take up one of the seats in the space vehicle, is too great. General Satava's, a general surgeon, solution to this problem is surgical simulation. Satava80 recruited Anvari, a laparoscopic/robotic surgeon from the University of Toronto, to train the NASA astronauts in initiation of a pneumoperitoneum and insertion of laparoscopic trocars.81 In Satava's plan, the other astronauts would next attach a surgical robot and insert its surgical instruments into the abdomen. The operation would then be performed by a surgeon on Earth who is remotely controlling the robotic surgery instruments on Mars. The major impediment to this approach is again the latency period between the Surgeon's console sending a control signal to the remote robot, the robot performing the task, and the return signal to the surgeon's console updating the video image as well as the electronic signal updating the computer on the threedimensional position of each instrument and camera. Because of the speed of light and the distance between Earth and Mars, this latency period is too long to perform an operation. Satava's solution to this problem is surgical simulation. In Satava's model, digital data from a CT scanner or other imaging devices available in the Mars station is used by computers both in the surgeon's console on Earth and the surgical robot on Mars to construct an astronaut-specific simulation of his anatomy. The

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Fig. 7. Professor Marescaux of the IRCAD European Institute of Telesurgery (EITS) and International Institute for Image-Guided Surgery in Strasbourg, France has pioneered efforts at developing Augmented Reality Surgery. This series of CT scan image reconstructions demonstrates some of this process. A): The CT scan documents the anatomy and the pathological findings in the patients and then color codes it as might be seen in an anatomy textbook. B): Using these color-coded images the surgeon plans his operation. C): Volumetric measurements are made in liver resections are planned. D, E & F): During the actual operation, the color coded patient-specific CT scan images are superimposed on the 3-dimensional video image projected with the binocular system of the da Vinci Surgeon’s Console. This permits the surgeon to anticipate reaching or avoiding important anatomic structures during his dissection. (Courtesy of Professor Marescaux).

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surgeon on Earth operates on the simulation on Earth. The computer instructs the surgical robot on Mars what actions to take. The Mars robot performs the task and then sends back an update of the video image and the three-dimensional location of the surgical instruments. The data is exchanged continuously. As a result, the surgeon performs the operation on a simulation of the patient, which lags several seconds behind the actual procedure on Mars. The astronauts on Mars, of course, are trained to deal with any unexpected problems.

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