Evolving Role and Current State of Robotics in Minimally Invasive Gynecologic Surgery

Review Article

Evolving Role and Current State of Robotics in Minimally Invasive Gynecologic Surgery Arnold P. Advincula, MD, and Karen Wang, MD From the Department of Obstetrics and Gynecology, University of Michigan Medical Center, Ann Arbor, (Dr. Advincula) and Beth Israel Medical Center, New York, New York (Dr. Wang).

ABSTRACT Advancements in conventional laparoscopy afford gynecologists the ability to treat disease with minimally invasive interventions. Procedures such as hysterectomy are still performed predominantly via laparotomy. Instrumentation, complex disease, and steep learning curves are often cited as obstacles to minimally invasive surgery. The advent of robotic technology may provide a means to overcome the limitations of conventional laparoscopy through the use of 3-dimensional imaging and more dextrous and precise instruments. Current studies clearly demonstrate the feasibility and safety of applying robotics to the entire spectrum of gynecologic procedures. Rigorous scientific studies and long-term data are needed to determine the appropriate applications of robotics in gynecology. Numerous questions still exist pertaining to costs, credentialing and privileging, and training. Journal of Minimally Invasive Gynecology (2009) 16, 291–301 Ó 2009 AAGL. All rights reserved. Keywords:

Robotics; Laparoscopy; Computer-assisted surgery

The evolution and use of the term ‘‘robot’’ has a long and interesting history. In its simplest form, it is defined by the Robotic Institute of America as ‘‘a machine in the form of a human being that performs the mechanical functions of a human but lacks sensitivity. [1].’’ A device that met this definition was developed as early as 1495 by Leonardo da Vinci. It was a mechanical armored knight used to amuse royalty. Although other examples of early robots exist in history, the concept of robotics did not enter the popular consciousness until the early 1900s. The term ‘‘robot’’ was originally coined in 1920 by playwright Karel Capek in his satirical drama Rossum’s Universal Robots. He derived the word robot from the Czech rabota, meaning serf or laborer. In the play, there was an evolution of the robots with increasing capabilities and the eventual revolt of these robots against their human counterparts.

Financial Disclosure: Dr. Advincula is a consultant for Intuitive Surgical, Inc., Sunnyvale, California. The authors have no commercial, proprietary, or financial interest in the products or companies described in this article. Corresponding Author: Arnold P. Advincula, MD, Department of Obstetrics and Gynecology, University of Michigan Medical Center, L 4000 Women’s Hospital, 1500 E. Medical Center Dr., Ann Arbor, MI 48109. E-mail: [email protected] Submitted November 19, 2008. Accepted for publication March 6, 2009. Available at www.sciencedirect.com and www.jmig.org 1553-4650/$ - see front matter Ó 2009 AAGL. All rights reserved. doi:10.1016/j.jmig.2009.03.003

Soon thereafter, Isaac Asimov published a collection of short stories. This eventually led to his well-popularized 3 laws of robotics: a robot may not injure a human being or through inaction allow a human being to come to harm; a robot must obey the orders given it by human beings except where such orders would conflict with First Law; and a robot must protect its own existence as long as such protection does not conflict with the First or Second Law [2]. Although robots began as theoretical constructs devised from science fiction novels, they soon became a reality in the automobile industry in 1958 when General Motors introduced the Unimate to assist in production [3]. Since then, robots have been used in a variety of applications including deep-sea and space exploration, industrial tasks, and entertainment, to name a few. Almost 30 years later, robotics was introduced in the field of medicine. In 1985, a robotic arm was modified to perform a stereotactic brain biopsy with 0.05-mm accuracy [4]. The original model, known as the PUMA 560, was used for neurosurgical stereotactic maneuvers under computed tomographic guidance. Similarly, a robotic system called the PROBOT was created to aide in the transurethral resection of the prostate gland with guidance from a preoperatively constructed 3-dimensional image [5]. In 1992, a device called ROBODOC was being used in orthopedic surgery to perform total hip replacements [6]. The surgeon supplied the dimensions and measurements based on presurgical images, and the ROBODOC performed the procedure based on that information.

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A common theme to these early designs was the way in which the robots functioned. They were developed to function autonomously with a preoperative plan or in a supervisory role. This passive role soon evolved into a more active role with an immersive environment that became known as robotic telepresence technology. The concept of robotic telepresence technology was initiated through the collaborative efforts of the Stanford Research Institute, the Department of Defense, and the National Aeronautics and Space Administration [7]. The impetus for this concept was the need to provide immediate operative care to wounded soldiers on the battlefield from a remote location. Initial prototypes involved robotic arms that could be mounted on an armored vehicle to facilitate remote battlefield surgery. Soon this technology was commercialized, and robots were no longer just passive devices in surgery but could be actively controlled in civilian operating rooms. Based on this interest in remote robotic operation, the Pentagon Defense Advanced Research Projects Agency funded development of AESOP (Automated Endoscopic System for Optimal Positioning; Computer Motion, Inc, Galeta, California) [3]. Intended to replace a surgical assistant in laparoscopic surgery, AESOP consists of a voice-activated system and a robotic arm for endoscopic camera control. Although robotic telepresence technology was initially created for use in cardiac surgery [8], before long, these developments were applied to the field of gynecology. Herein, we highlight the evolution of robots in surgery and the critical role that gynecologists had in evaluation of the technology. Evolution of Robots in Medicine HERMES The first attempt to increase the control of the surgeon in using automation over the surgical field was a voice-activated system designed and developed by Computer Motion, Inc. The HERMES system used voice recognition to control the laparoscopic camera, light source, insufflation, printer, phone, operating room lights, and patient table position [9]. A randomized controlled trial by Luketich et al [10] in 2002 of 30 patients undergoing laparoscopic antireflux surgery demonstrated fewer interruptions for instrument adjustment and greater surgeon and operating room staff satisfaction in the HERMESassisted case group compared with the control group. AESOP As one of the early predecessors and first applications of robotic technology in surgery, AESOP (Computer Motion, Inc) was the first surgical robot to be approved by the US Food and Drug Administration (FDA), in 1994. Designed to reduce surgeon fatigue and offer a stable visual field by controlling the camera during laparoscopy, this active robotic device had motorized joints that were voice activated via the HERMES speech recognition program [9,11]. Gynecologists had an early role in the evaluation of this technology. One study by Mettler

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et al [12] compared the system to a surgical assistant holding the laparoscope during gynecologic surgery. The authors found that the time required to perform surgery was shorter with the robotic camera holder because it improved efficiency by allowing the 2 surgeons to use both hands for operating. ZEUS Under the direction of Computer Motion, Inc, AESOP evolved into the Zeus surgical system with the addition of 2 robotic arms. The company originally developed the Zeus minimally invasive surgical robot system in 1999 for use in cardiac operations. In 2001, the FDA approved this surgical system for use in laparoscopic surgery. Constructed as a master-slave device, this 2-component system consisted of a master console where the surgeon sat comfortably and directed the slave robotic instruments. At the console, the surgeon controlled the robotic arms by maneuvering 2 form-fitted handles (similar to a joystick that fits in the palm of the hand) while viewing a flat video monitor. To achieve 3D visualization, polarized glasses were worn by the surgeon [3,9]. Through a computer interface, tremors were eliminated as the surgeon’s hand movements were downscaled over a range of 2:1 to 10:1 (as an example, with every 1 cm of movement of the control handles, the robotic instruments moved 1 mm at the surgical site) [13]. Three remotely controlled robotic arms were mounted on the operating table. These robotic arms operated the camera in a manner similar to that with AESOP but also provided the surgeon with 2 operating arms with interchangeable MicroWrist instruments (Computer Motion, Inc) that more closely mimic the movements of the human wrist when compared with conventional laparoscopic instruments. The potential axes of motion of the surgical instruments were called ‘‘degrees of freedom,’’ of which there are 7: in-and-out movement, axial rotation, opening and closing the instrument, lateral movement at the articulation, vertical movement at the articulation, left movement at each articulation, and right movement at each articulation. This early robotic system represented a significant paradigm shift that moved the surgeon away from the operating room table to a remote console, a theme that would be carried over with future devices. The Zeus surgical system was the first robotic device to truly test the concept of telesurgery, which, defined broadly, is the ability to perform surgery from a distance [14]. In a 45minute operation entitled ‘‘Lindbergh,’’ surgeons in New York, New York, successfully performed a laparoscopic cholecystectomy in a patient in Strasbourg, France, in 2001. This was accomplished with a time delay of less than 200 ms between the controls in New York and the action of the instruments on the patient in Strasbourg. Two communication systems were used to link both the video feed and a telephone link using a fiberoptic service [15,16]. Two years later in 2003, one of the first remote telesurgical services was designed in Canada. Anvari et al [17] created a program by which the Zeus surgical system was set up in

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Robotics in Minimally Invasive Gynecologic Surgery

Hamilton, Ontario, for the surgeon and the robotic arms were positioned on the patient in North Bay, Ontario, 400 km away. They were able to use a preestablished commercial network as a communication link between the 2 locations. Twenty-one laparoscopic surgeries including fundoplications, sigmoid resections, and hemicolectomies were completed successfully with this setup. The 2 surgeons in different locations were able to operate simultaneously with little time delay for communication and signal reception. They reported no substantial complications. Although these 2 examples demonstrate the feasibility of long-distance telesurgery, costs are an important issue. In addition, the Integrated Services Digital Network and the Internet are currently used to transfer information over long distances, thereby making consistency and reliability problematic. Early studies in the gynecologic arena reported successful application of the Zeus surgical system in tubal anastomosis. In 1 prospective study, pregnancy rates were evaluated in 10 patients with previous tubal ligations who underwent laparoscopic tubal anastomosis using the identical technique used at laparotomy [18]. A postoperative tubal patency rate of 89% was demonstrated in 17 of the 19 tubes anastomosed, with a pregnancy rate of 50% at 1 year. There were no complications or ectopic pregnancies. SOCRATES During the same time as it approved Zeus, the FDA also approved Socrates (Computer Motion, Inc). Socrates was a robotic telecollaboration device that facilitated telementoring. The telementor from a remote site used this program to connect with an operating room and share audiovisual signals. Socrates had a telestrator that could annotate anatomy or surgical instructions and a voice-controlled system that could control camera movement and other electronic equipment in the distant operating room [19]. Da Vinci Surgical System Today’s platform of surgical robotics revolves around the da Vinci surgical system (Intuitive Surgical, Inc., Sunnyvale, California), which is the only actively produced and FDAapproved robotic surgical system incorporating an immersive telepresence environment. Intuitive Surgical, Inc, acquired Computer Motion, Inc., in 2003 and subsequently phased out the Zeus surgical system [3]. Similar to the Zeus surgical system, this master-slave device is composed of 3 components. The first component is the surgeon console where the surgeon controls the robotic system remotely (Fig. 1). The console contains large microcomputer motherboards that direct the movement of the robotic arms. A stereoscopic viewer and hand and foot controls are housed in this unit. Seated at the console, the surgeon sees the surgical field through a stereoscopic viewer while maneuvering both hand and foot controls simultaneously. The stereoscopic viewer also has an infrared sensor that deactivates the robotic arms whenever the surgeon moves

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Fig. 1. Surgeon console.(Ó2009 Intuitive Surgical, Inc.)

his or her head out of the console [20]. Foot pedals located at the base of the console facilitate various functions including positioning of the camera, focus adjustment, activation of monopolar or bipolar energy sources, repositioning of the handgrips via a clutch mechanism, and toggling between instruments (a feature specific to the use of 4 robotic arms). The second component of the da Vinci Surgical System is the InSite vision system, which provides 3D stereoscopic imaging via a 12-mm endoscope (Fig. 2). Because the endoscope of the da Vinci Surgical System is composed of 2 parallel 5mm telescopes (0- or 30-degree lenses) that are each capable of sending individual images to the camera head, a 3D view of the surgical field is seen at the console as the 2 images are merged by a computer. The video system provides 10! to 15! magnification and the option of high definition. The images are also projected such that the surgeon’s hands simulate operating instruments over an open surgical field. In addition, the endoscope is programmed to regulate the temperature at the tip to minimize fogging during surgery. The third component of the da Vinci Surgical System is the patient-side cart with EndoWrist instruments and either 3 or 4 robotic arms (Fig. 3). One of the arms holds the laparoscope, and the other 2 or 3 arms hold the various interchangeable EndoWrist instruments, which measure either 5 or 8 mm in diameter. Each grasping instrument has its own preprogrammed maximum pressure and can be used in as many as 10 operations before being replaced [3,9]. These laparoscopic surgical instruments also have the 7 degrees of freedom that replicate the full motion of the surgeon’s hand, thus functioning instinctively and overcoming the fulcrum effect noted in conventional laparoscopy. A myriad of laparoscopic instruments are available including needle drivers, Debakey forceps, and monopolar scissors that are placed through specific telerobotic ports [20]. These instruments enable the surgeon to manipulate, coagulate, dissect, and suture. This system also allows a greater variety of scaled motion for precise and accurate control (5:1, 3:1, or 1:1) while eliminating tremors [3,9,21]. Although articulation is

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Fig. 2. Twelve-millimeter InSite vision system endoscope. (Ó2009 Intuitive Surgical, Inc.)

greatly enhanced, there is an absence of tactile (haptic) feedback to the surgeon manipulating the instruments. Two models currently exist, the original da Vinci Surgical System (known as the Standard) and the newest version, the S System, which was released in 2006. Modifications of the original system include the addition of a fourth surgical arm, longer instruments, increased variety in 5- or 8-mm instruments, an interactive video display, motorized side cart, high-definition viewing, and a more streamlined design [3]. Included in the interactive video display is the ability to telestrate, whereby a surgical assistant is able to guide a remotely seated surgeon during the procedure. Additional panels of images such as radiologic imaging can also be integrated into the operative view of the surgeon seated at the console. Robot-assisted Laparoscopy vs Conventional Laparoscopy As robotic technology has gained popularity in the various surgical specialties, studies comparing laparoscopic vs robotic performance in laboratory drills have emerged. These studies demonstrate improved accuracy, fewer errors, a shorter learning curve, and faster intracorporeal suturing and knot tying [22]. These attributes of robotic assistance provide a means of performing traditional open surgery via minimally invasive methods. In addition, they facilitate successful completion of complex laparoscopic procedures by less skilled or experienced surgeons. Evidence of this robotic advantage was demonstrated by Chang et al [23] in 2003. Those authors compared intra corporeal knot tying, timed drills, and errors with the Zeus robotic system vs. conventional laparoscopy in nonexperienced and experienced laparoscopists. Robotic technology clearly demonstrated faster times in drill performance, fewer errors, and a shorter learning curve. In another study that compared laparoscopic and robotic suturing, robotic assistance enhanced dexterity by 50% as a result of improved articulation and scaled motion, and 3D vision improved dexterity by 60% to 65%. Enhanced visualization reduced skill-based errors by 93% [24].

Fig. 3. A, Patient-side cart with 4 robotic arms. (Ó2009 Intuitive Surgical, Inc.) B, EndoWrist instruments. Two large needle drivers are used in robot-assisted laparoscopic myomectomy. (Ó2009 Intuitive Surgical, Inc.)

Yohannes et al [25] in 2002 conducted the first study to compare the learning curve between manual and robot-assisted tasks. The difference in completion time between the first and last trial determined the learning curve. Two tasks were tested: passing suture through 7 needles on a wooden block in a P configuration to evaluate dexterity and tying 3 intracorporeal sutures (1 surgeon’s knot and 2 subsequent ties). A statistically significant difference and advantage for the dexterity task was demonstrated with robotics.

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Dakin and Gagner [26] compared basic and fine laparoscopic skills when using traditional laparoscopy vs. robotic assistance (Zeus and da Vinci surgical systems). In their study, neither robotic system improved basic skill performance when compared with standard laparoscopy. However, for the fine skills tasks, robotic assistance using the da Vinci Surgical System was the most precise. The participants had, on average, 3 years of laparoscopy experience, and only 2 of the 18 surgeons had ever used either robotic system. No comparison of repetitive use of either robotic system was made. Similarly, in a study of 21 surgeons with various surgical training and skill levels, Sarle et al [27] noted that novice surgeons were able to complete the complex drills at a rate comparable to that of experienced surgeons with the assistance of robotic technology.

important to note that it is not a replacement for minimally invasive procedures or approaches already done well. It is merely another laparoscopic tool that may provide a less invasive way to address gynecologic disease.

Robotics in Gynecology: the Rationale

Hysterectomy

Historically, surgery in gynecology has been accomplished via a vaginal or open abdominal approach. Although laparotomy may seem advantageous for the surgeon at first, with depth perception and tactile feedback from tissue, the large abdominal incision, prolonged hospitalization, increased postoperative analgesic requirements, and higher morbidity are disadvantages for the patient. The days of a surgeon obtaining access to the abdomen only at laparotomy have long passed. Laparoscopic surgery enables faster recovery with shorter hospitalization, improved cosmesis, decreased blood loss, and less postoperative pain [28,29]. Technical advancements have improved modern laparoscopy. These include high-intensity xenon and halogen light sources and improved hand instrumentation and energized devices. This technology has continued to grow rapidly in the area of minimally invasive gynecologic surgery. Despite these technologic advancements and proved benefits, more complex procedures such as management of advanced endometriosis and procedures that require extensive suturing such as myomectomy and sacrocolpopexy typically are still managed predominately by laparotomy. One major obstacle to the more widespread acceptance and application of minimally invasive surgical techniques in gynecologic surgery has been the steep learning curve for surgeons that is associated with many of these advanced procedures. Other limitations of conventional laparoscopy include counterintuitive hand movement (fulcrum effect), an unsteady two-dimensional visual field, and limited degrees of instrument motion within the body as well as ergonomic difficulty and tremor amplification [30]. In an attempt to overcome these obstacles, robotics has been incorporated in the gynecologic resources as a possible solution. Overall, the integration of robotics in gynecology continues to be driven by the intent to improve the surgical capabilities of the surgeon with consistent accuracy and precision in order to perform complex surgery at laparoscopy rather than at laparotomy. While a rationale for implementing robotics in gynecologic surgery is extremely important, it is equally

Hysterectomy is a great example of the application of minimally invasive surgical techniques to a gynecologic procedure. As a result of the evolution of surgical technology, the approaches by which hysterectomy is performed have also evolved. This is seen in the transformation of hysterectomy from both the abdominal and vaginal approach to the laparoscopic-assisted vaginal hysterectomy and, eventually, the laparoscopic supracervical and total laparoscopic hysterectomy [31–33]. Despite these advancements in surgical technique, in 2002, Farquhar and Steiner [34] reported that only 10% of hysterectomies were performed minimally invasively with the assistance of laparoscopy. That same year, Kovac et al [35] demonstrated a 91.8% completed vaginal hysterectomy rate in 407 consecutive women in a resident clinic setting who were assigned prospectively to either an abdominal or vaginal approach based on Society of Pelvic Reconstructive Surgeons guidelines. In a recent study, Wu et al [36] found that of 538 722 hysterectomies performed in 2003 because of benign disease, 66.1% were performed abdominally, 21.8% were performed vaginally, and only 11.8% were performed laparoscopically. Despite the best efforts of vaginal surgery proponents such as Kovac and colleagues and a definite trend toward laparoscopic hysterectomy that has been noted since the 1990s, hysterectomy via laparotomy remains the preferred approach over the less invasive vaginal or laparoscopic approach. Robotics has been viewed as a possible technology to facilitate the trend toward laparoscopy, and in the gynecologic literature, several authors have evaluated robot-assisted laparoscopic hysterectomy and patient outcomes. Diaz-Arrastia et al [37] in 2002 reported one of the earliest experiences with robot-assisted laparoscopic hysterectomy. This series included 16 patients ranging in age from 27 to 77 years. Operative time ranged from 270 to 600 minutes, and blood loss was 50 to 1500 mL (mean, 300 mL). Hospital stay was 2 days (range, 1–3 days). Although their approach was labeled a laparoscopic hysterectomy, all cases in that series were type IIB according to the American Association of Gynecologic

Robotic Applications in Gynecology Currently, the da Vinci Surgical System is the only robotic system that is approved by the FDA for laparoscopic procedures in general surgery, cardiothoracic surgery, urology, and gynecology [3]. It was initially approved in 2000 for general laparoscopic use, and as of April 2005, this surgical system was given FDA clearance for use in gynecologic procedures. We review the current applications and supporting literature in gynecology.

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Laparoscopists (AAGL) classification system for laparoscopic hysterectomy; that is, the posterior culdotomy and ligation of the cardinal and uterosacral ligament complexes were performed vaginally to complete the hysterectomy [38]. Advincula and Reynolds [39] reported the first series of 16 consecutive patients who underwent either an AAGL type IVE hysterectomy (totally laparoscopic removal of the uterus and cervix including vaginal cuff closure) or an LSH III hysterectomy (totally laparoscopic supracervical procedure with removal of the uterine corpus including division of the uterine arteries). The mean uterine weight was 131.5 g (range, 30–327 g). There were no conversions to laparotomy in this series. Specifically, an advantage was noted in patients with scarred or obliterated surgical planes; 13 of the 16 patients had undergone previous pelvic surgery and required intraoperative management of pelvic adhesions to complete the hysterectomy. The same authors carried this advantage over to a series of 6 patients undergoing successful hysterectomy who had a scarred or obliterated anterior cul de sac as a result of previous cesarean deliveries [40]. Lenihan et al [41] recently published a series of 100 benign robotic hysterectomies that included laparoscopyassisted vaginal hysterectomy, total laparoscopic hysterectomy, and laparoscopic supracervical hysterectomy [41]. Unique to their series was the finding that total operative time for hysterectomies studied sequentially stabilized at approximately 95 minutes after 50 cases, and there were no conversions to laparotomy. A study by Kho et al [42] described another large series of patients who underwent robot-assisted laparoscopic hysterectomy at the Mayo Clinic. Ninety-one patients underwent hysterectomy because of primarily benign gynecologic conditions. Similar to the series by Lenihan et al [41], no conversions to laparotomy were necessary. Smaller series of robot-assisted AAGL type IVE cases have been reported by Beste et al [43] and Fiorentino et al [44]. In both studies, operative results were similar to those with conventional laparoscopic hysterectomy. The only study to date comparing robotic hysterectomy with conventional laparoscopy is by Payne and Dauterive [45]. Their experience involved a retrospective review of their last 200 consecutive hysterectomies completed before and after implementation of a robotics program. There were no statistically significant differences in patient characteristics or uterine weight between the 2 groups. The rate of intraoperative conversion to laparotomy was twice that in the prerobotic cohort of 100 patients compared with the robotic cohort (9% vs 4%). Mean blood loss was also significantly reduced in the robotic cohort. However, the incidence of adverse events was the same in both groups. Despite significant advantages with the robotic approach to hysterectomy, Nezhat et al [46] described disadvantages with their early robotic experience. They found the absence of tactile (haptic) feedback, bulkiness of the system, lack of vaginal access, and costs to be limiting factors; however, their experience included only 3 robotic hysterectomies, which were performed very early in their learning curve.

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Reproductive Surgery Myomectomy Endoscopic management of leiomyomas is one of the more challenging procedures in minimally invasive surgery and requires a skilled surgeon. Although 2 prospective trials have shown postoperative morbidity to be less and recovery faster with laparoscopic myomectomy, most procedures are still performed via laparotomy [47,48]. The ability to enucleate leiomyomas and adequately perform a multilayered closure, the associated learning curve, concern about uterine rupture, and the risk of recurrence, which seems to be higher after laparoscopic myomectomy compared with laparotomy, may explain the reluctance to shift to a laparoscopic approach [49]. The use of robot-assisted laparoscopy represents an attempt to overcome the difficulties encountered with the key steps of hysterotomy, enucleation, repair, and extraction during conventional laparoscopy [50]. The earliest published series of robot-assisted laparoscopic myomectomy was from Advincula et al [51]. In their series of 35 patients, mean (SD) myoma weight was 223.2 (244.1) g (95% confidence interval [CI], 135.8–310.6). The mean number of myomas removed was 1.6 (range, 1–5), and the mean diameter was 7.9 6 3.9 cm (95% CI, 6.6–9.1). Mean estimated blood loss was 169 (198.7) mL (95% CI, 99.1–238.4). No blood transfusions were necessary. Mean operating time was 230.8 (83) minutes (95% CI, 201.6–260.0). Median length of stay for these patients was 1 day. Total conversion rate was 8.6%, comparable to other published studies of conventional laparoscopic myomectomy with ranges from 0% through 28.7%. Two of the reported conversions were secondary to an absence of tactile (haptic) feedback, which made enucleation of the leiomyomas difficult. The largest comparative study to date of robotic myomectomy compared with the criterion standard approach of laparotomy is also by Advincula et al [52]. Fifty-eight patients with symptomatic leiomyomas were studied in a retrospective case-matched analysis with 29 patients in each arm. As would be expected, there were no differences in the case-matched variables of age, body mass index, and fibroid weight. Noteworthy were the findings of decreased estimated blood loss (mean, 195.69 [228.55] mL; 90% central range (CR), 50.00–700.00 vs 364.66 [473.28] mL; 90% CR, 75.00–550.00) and length of stay (mean 1.48 [0.95] days; 90% CR, 1.00–3.00) vs 3.62 [1.50] days; 90% CR, 3.00–8.00) compared with the laparotomy group. Both of these differences were statistically significant at p , .05. Complication rates were also lower in the robotic group. Operative time was longer in the robotic group (mean, 231.38 [85.10] minutes; 95% CI, 199.01–263.75) vs 154.41 [43.14] minutes; 95% CI, 138.00–170.82) (p , .05). In a smaller retrospective case-matched study, 15 patients who underwent robotic myomectomy were compared with 35 patients who underwent conventional laparoscopic myomectomy [53]. Mean surgical time was 234 minutes (range, 140–445 minutes) in the robotic group compared with

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203 minutes (range, 95–330 minutes) in the conventional laparoscopy group. Estimated blood loss, length of stay, and postoperative complications were not significantly different between the 2 groups. The authors concluded that in the hands of a skilled surgeon, the robotic approach did not confer any major advantage over conventional laparoscopy. Tubal Anastomosis Because tubal anastomosis requires adequate visualization of the fallopian tube lumen, precise suturing, and careful manipulation of delicate tubes, the use of robotic technology is a natural consideration. Robotic systems confer enhanced visualization and dexterity of instruments along with tremor filtration to facilitate these steps while maintaining minimally invasive techniques. Falcone et al in 2000 used the Zeus surgical system for tubal anastomosis and conducted the first clinical trial in human beings using a robotic system in the field of gynecology [18]. In this prospective study, pregnancy rates were evaluated in 10 patients who had previously undergone tubal ligation and who underwent laparoscopic tubal anastomosis using the identical technique used at laparotomy. A postoperative tubal patency rate of 89% was demonstrated in 17 of the 19 tubes anastomosed, with a pregnancy rate of 50% at 1 year. There were no complications or ectopic pregnancies. Although much has been written by Falcone et al [18] on their early work with the Zeus Surgical System, little has been published as it pertains to today’s platform of surgical robotics. In 2000, Degueldre et al [54] reported their feasibility study in 8 patients who had previously undergone laparoscopic tubal sterilization and who requested tubal reanastomosis. Sixteen tubes were successfully repaired. Mean time that the robotic system was in use was 140 minutes, and mean surgical time was 52 minutes per tube. Five of the 8 patients underwent hysterosalpingography, which demonstrated at least unilateral patency, and 2 pregnancies were reported within 4 months after surgery. The authors noted the absence of tactile feedback to be a disadvantage but, overall, found that operating time compared favorably with that required to perform open microsurgery. Similar operating times were noted in a second study by Cadiere et al [55] that included 28 patients. Two comparative studies have been published in the area tubal reversal. The first by Dharia and Falcone [20] was a feasibility study in a fellowship training program and compared 18 patients who underwent tubal sterilization reversal using the da Vinci surgical system with 10 patients who underwent traditional open microsurgical anastomosis. While operative time was significantly greater in the robotic group, hospitalization time and recovery were significantly shorter in the same group. In both groups, the patency rate was 100%, and the pregnancy rate was 50% [20]. Results from a second retrospective case-control study comparing women undergoing tubal anastomosis via minilaparotomy vs robot assistance was reported in 2007 by Rodgers et al [56]. Results are given in Table 1. Although return to normal activity was shorter with the robotic technique, it required significantly prolonged surgical and anesthesia times.

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Hospitalization time, pregnancy rate, and ectopic pregnancy rate were not significantly different between the 2 groups. Ovarian Transposition Although a much less commonly performed procedure, ovarian transposition is the anatomical relocation of the ovaries from the pelvis to the abdomen. This procedure enables maintenance of ovarian function and preservation of reproductive capacity. The conventional laparoscopic approach has been extensively described in the literature, with more than 46 cases [57]. Use of the robotic approach has been described in 1 case report thus far. The surgeons used this technique in a patient before she received radiotherapy for stage I-B1 cervical squamous cell carcinoma. Postirradiation levels of 4.9 mIU/mL of follicle-stimulating hormone and 2.5 mIU/mL of luteinizing hormone confirmed preservation of ovarian function [58]. The authors concluded that the enhanced 3D visualization and articulation with the EndoWrist instruments facilitated the extensive dissection and suturing needed to complete the procedure.

Oncology A natural progression of robotic technology in gynecology has been to the area of oncology. In 2005, experiences in both Europe and the United States were published. The first, by Marchal et al [59] evaluated 12 malignant neoplasms: 5 endometrial adenocarcinomas and 7 cervical carcinomas. The mean number of pelvic lymph nodes removed was 11 (range, 4–21). No port-site metastasis or recurrences were found at a mean follow-up of 10 months (range, 2–23 months). A second study involved 7 malignant neoplasms: 4 endometrial, 2

Table 1

Comparison of tubal anastomosis using robot assistance vs minilaparotomy

Variable Operative time, min Estimated blood loss ,100 mL Weeks to return to work Pregnancy rate, % No. of pregnancies Ectopic pregnancy rate, % Complication (No. of patients)

a

Statistically significant.

Robot assistance (n 5 26)

Minilaparotomy (n 5 41)

229 (205–252)a 19 (73%)

181 (154–202) 31 (80%)

0.8 (0.5–2.9) 61 19 11 Tachycardia (1)

2.8 (1.0–3.4) 79 47 13 Postoperative fever (1), cellulitis (1), wound separation (1), readmission because of abdominal pain (1), incisional hernia (1), excessive nausea and vomiting (1)

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ovarian, and 1 fallopian tube lesion [60]. The median lymph node count was 15 (range, 4–29). Both early experiences clearly demonstrate the feasibility of applying robotic assistance to laparoscopic cancer staging without an increase in complication rate or compromise to surgical technique. Other feasibility studies have since followed [61–64]. As the application of robotics to gynecologic oncology has evolved, a growing body of evidence to support its use in early-stage cervical cancer treatment has developed. Sert and Abeler [65] in an early comparative study of 7 robot-assisted vs 8 conventional laparoscopic radical hysterectomies demonstrated less bleeding (71 vs 160 mL; p 5 .04) and a shorter hospital stay (4 vs 8 days; p 5 .004) with the robotic approach. All other surgical markers were similar between the 2 groups. In contrast, Nezhat et al [66] performed a similar comparative study of 13 robot-assisted vs 20 conventional laparoscopic radical hysterectomies and found equivalence between the 2 approaches insofar as operative time, estimated blood loss, hospital stay, and oncologic outcome. In a recently published study, Boggess et al [67] in the largest series to date compared 51 consecutive robot-assisted type-III radical hysterectomies with 49 open radical hysterectomies. No differences in patient demographic data were noted; however, there were significant differences between the groups in estimated blood loss, operative time, and lymph node count, all of which favored the robotic group. A lower complication rate and shorter hospital stay were also noted in the robotic cohort. The only comparative study of robot-assisted (n 5 18), conventional laparoscopic (n 5 18), and traditional open radical hysterectomy (n 5 21) is by Magrina et al [68]. These authors found a statistically significant difference in operative time between the 3 groups, with robotics requiring a longer time than conventional laparoscopy (mean, 185 vs 216 minutes) but comparable operative time as with traditional open surgery (mean, 185 vs 157 minutes). Estimated blood loss and median length of hospital stay were also lowest in the robotic group. Robot-assisted endometrial cancer staging has emerged as a promising application. The best study to date, by Boggess et al, [69] compared 321 patients who underwent endometrial cancer staging via 1 of 3 routes: robot-assisted (n 5 103), conventional laparoscopy (n 5 81), and traditional laparotomy (n 5 138). The highest lymph node yield, least estimated blood loss, and shortest hospital stay was found in the robotic cohort. These data suggest that the robotic approach may be preferable to others [69]. As promising as all of the data about both cervical and endometrial cancer staging seems, they represent only shortterm outcomes. Long-term cancer survival data will need to be evaluated to determine the true durability of a robot-assisted approach. Further studies will need to be carried out to determine additional oncologic applications such as malignant ovarian tumor management. Surgeons in Belgium have demonstrated the successful application of robotics to cytoreductive surgery to treat lobular carcinoma of the breast metastatic to the ovaries [70].

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Pelvic Reconstructive Surgery Abdominal sacrocolpopexy is an excellent treatment option in patients with high-grade vaginal vault prolapse, with long-term success rates ranging from 93% to 99%. The goals of surgical repair include restoring proper anatomy, maintaining sexual function, and durability. It requires dissection of the retroperitoneal space with suturing of mesh from the vagina to the sacral promontory. Typically, it is performed at laparotomy and is associated with prolonged hospitalization and convalescence. It is also associated with increased morbidity compared with repair vaginally. Several studies incorporating the robotic approach to replicate the principles involved with the open technique while taking advantage of the decreased morbidity associated with laparoscopy have been published. DiMarco et al [71] published a feasibility study of 5 women who underwent robot-assisted laparoscopic sacrocolopexy. Their mean age was 62 years, and mean operative time was 3 hours 42 minutes. A hybrid approach was taken in that conventional laparoscopy was used to prepare the vaginal and presacral space and the robot was used to suture the mesh in place. Follow-up at 4 months demonstrated no recurrent vaginal vault prolapse. Elliott et al [72] reported their initial experience in 30 patients with posthysterectomy vaginal vault prolapse. Patient mean age was 67 years (range, 47–83 years), and mean operative time was 3.2 hours (range, 2.15–4.75 hours). Most patients were discharged to home on the first postoperative day. Although only 21 patients had a minimum follow-up of 12 months (mean, 24 months; range, 12–36 months), patient satisfaction was high, and only 1 patient developed recurrent vaginal vault prolapse. More recently, Geller et al [73] compared 73 patients who underwent robot-assisted laparoscopic sacrocolpopexy with 108 patients who underwent traditional abdominal sacrocolpopexy in a retrospective cohort study. Longer operative time, less blood loss, and shorter length of stay were noted with the robotic approach. Vaginal vault support was similar between the 2 groups; however, follow-up was short at only 6 postoperative weeks. As experience with robotics in pelvic reconstructive surgery continues to grow, other applications are sure to emerge. One such example is the use of a robot-assisted laparoscopic approach to repair a vesicovaginal fistula [74]. Similar to oncologic applications, long-term studies will need to be performed to determine the true durability of robot-assisted pelvic reconstructive surgery as it pertains to issues such as recurrent vaginal vault prolapse. Learning Curve The characterization of learning curves in robotic surgery has been slow to develop. To date, only 2 studies have specifically evaluated learning curves in gynecologic surgery. The first, by Pitter et al, [75] compared estimated blood

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loss and operative time in robot-assisted laparoscopic hysterectomies and myomectomies performed by a single surgeon. The first 20 cases were compared with the second 20 cases. No significant differences in estimated blood loss were found between the 2 groups; however, mean total operative time was significantly shorter in the second group: 212 minutes in the first group compared with 151 minutes in the second group. There were no conversions to laparotomy [75]. A second study by Lenihan et al [40] evaluated 113 sequential patients over 22 months. Those authors found that surgeon console times for hysterectomies studied sequentially stabilized at approximately 95 minutes after 50 procedures. Similarly, 20 procedures were required for the operating room team to be able to consistently set up the robot for surgery in 30 minutes. Two other studies allude to learning curves. The first, by Kho et al, [41] addressed the issue of ‘‘docking times’’ by demonstrating decreasing times for subsequent groups of 10 patients in their series of 88 patients. Their mean docking time was 2.95 minutes. Payne and Dauterive [44] noted substantial improvement in mean operative time in their robotic cohort after 75 procedures. They observed a mean operative time for laparoscopic hysterectomy in the prerobotic cohort of 100 procedures of 92.4 minutes vs 119 minutes in the immediate postrobotic cohort of 100 procedures. The authors noted shorter operative time (mean, 78.7 minutes) in the last 25 robotic procedures compared with the prerobotic operative time [44]. As demonstrated by these various studies, 20 to 75 procedures are required to transcend the early learning curves associated with robot-assisted surgery. Costs Costs remain in the forefront of issues to be addressed when implementing robotics in a gynecologic practice. Each current robotic surgical system retails for approximately $1.6 million and is associated with an annual maintenance contract of at least $100,000. The EndoWrist instruments, which retail for approximately $2000 each, have limited (10) patient uses. A minimum of 3 or 4 Endo Wrist instruments are required for each case, that is, $200 per instrument 5 $600 to $800 per procedure, assuming 10 cases per instrument before replacement. In addition, there is the cost of drapes and other disposable equipment. Other costs to consider are the required training fees for surgeons and operating room personnel and the effect of learning curves on the costs involved with longer operative time and decreased productivity. Three studies in the reproductive surgery realm specifically address the issue of costs. The first, by Rodgers et al, [56] evaluated differences between tubal anastomosis using robotic compared with outpatient minilaparotomy. The costs were greater with the robotic approach; the median difference in costs of the procedure was $1446 (95% CI, $1112-$1812; p , .001). In a contrasting study, Dharia et al [76] found the cost per delivery to be similar between robotic tubal anasto-

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mosis and the open approach. Advincula et al [52] evaluated cost in their comparison of robot-assisted laparoscopic myomectomy vs laparotomy. They found professional (mean, $5946.48 vs $4664.48) and hospital charges (mean, $30 14;084.20 vs $13 14;400.62) to be statistically higher in the robotic group. Although professional reimbursement was not significantly different between the 2 groups, hospital reimbursement rates in the robotic group were significantly higher ($13 14;181.39 vs $7 14;015.24). As evidenced by these studies, the issues surrounding costs as it relates to robotic technology can be complex and often include complex calculations geared toward depreciation factors. Although costs certainly are an obstacle to implementation of advanced technologies, strides have been made in the billing arena, in particular, on the facility’s technical component side. One such example is the implementation of a new International Classification of Diseases, Ninth Revision, Clinical Modification subcategory code as of October 1, 2008: 17.42, Laparoscopic robot-assisted procedure. Conclusion The evolving literature on robot-assisted surgery in gynecology suggests that the surgical limitations of conventional laparoscopy can be overcome and that the skill level of the surgeon may be enhanced. At present, this seems to be the result of improved instrument precision and dexterity and 3D imaging. The feasibility and safety of applying this technology is clearly demonstrated in hysterectomy (both benign and oncologic) and specifically crosses over into reproductive surgery and urogynecology. As experience grows, well-designed prospective studies comparing robot-assisted surgery with conventional laparoscopy and traditional laparotomy will help characterize the true advantages and disadvantages of this new technology in addition to determining appropriate applications and users. Currently, only short-term data are available. Limitations such as the absence of tactile (haptic) feedback, bulky design of the instrumentation, and high cost will need to be addressed. Many questions still remain, in particular, related to the credentialing and privileging process and the appropriate training method for transference of skills to residents, fellows, and peers. Overall, robotics will likely be an important surgical resource for the minimally invasive gynecologist. References 1. Capek K, Capek J. The Insect Play. New York, NY: Oxford University Press; 1963. 2. Asimov I. Robots: Machine in Man’s Image. New York, NY: Harmony Books; 1985. 3. Hockstein NG, Gourin CG, Faust RA, Terris DJ. A history of robots: from science fiction to surgical robotics. J Robotic Surg. 2007;1: 113–118. 4. Kwoh YS, Hou J, Jonckheere EA, Hayati S. A robot with improved absolute positioning accuracy for CT-guided stereotactic brain surgery. IEEE Trans Biomed Eng. 1988;35:153–160.

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