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Emergence of robotic assisted surgery in gynecologic oncology: American perspective
Gynecologic Oncology 114 (2009) S24–S31
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Gynecologic Oncology j o u r n a l h o m e p a g e : w w w. e l s e v i e r. c o m / l o c a t e / y g y n o
Review
Emergence of robotic assisted surgery in gynecologic oncology: American perspective Alberto Mendivil a,1, Robert W. Holloway b,2, John F. Boggess a,⁎ a University of North Carolina, Chapel Hill, Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, 101 Manning Drive, CB 7572, Chapel Hill, NC 27599-7572. USA b Gynecologic Oncology Program, Florida Hospital Cancer Institute, 2501 N. Orange Avenue, Suite 689, Orlando, FL 32804, USA
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Article history: Received 21 November 2008 Keywords: Robotics Endometrial cancer Cervical cancer da Vinci
a b s t r a c t Objectives. To discuss the emergence of robotic surgery in gynecologic oncology and describe the growth of robotic surgery in a university medical center and a community based practice. Methods. In addition to the historical evolution of the robotic assisted surgery medicine, a survey of robotic cases was performed on two robotic programs since the inception of the programs. A review of the current literature on the use of the da Vinci robot in gynecologic oncology was also performed. Results. The robotic surgery programs at UNC Hospital and Florida Hospital are growing steadily since the inception of the programs in 2005 and 2006, respectively. Since 2005 there have also been numerous publications detailing the effectiveness, safety, and efficiency of the robot. Conclusions. Robotic surgery is gaining acceptance and is rapidly growing as evidenced by an increased number of publications on the topic; these publications demonstrate the safety, efficacy, and improved outcomes compared to open surgery and conventional laparoscopy. © 2009 Published by Elsevier Inc.
Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Evolution of surgical robotics . . . . . . . . . . . . . . . . . . . . . . . . Historical perspectives. . . . . . . . . . . . . . . . . . . . . . . . . . The da Vinci surgical system . . . . . . . . . . . . . . . . . . . . . . . . . Da Vinci surgical applications in gynecologic oncology . . . . . . . . . . . . Rationale and strategic approach to program building — a tale of two programs Program initiation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Public institution experience . . . . . . . . . . . . . . . . . . . . . . . Private setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Teaching residents, fellows, and colleagues . . . . . . . . . . . . . . . . . . Surgical skill-set requirements and strategies for acquisition and development . Concept of a minimally invasive surgical team . . . . . . . . . . . . . . . . Institutional commitment . . . . . . . . . . . . . . . . . . . . . . . . Strategies for building a robotic surgery team . . . . . . . . . . . . . . . . . Establishing guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . Patient selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . Protocols, algorithms, clinical pathways. . . . . . . . . . . . . . . . . . Clinical outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conflict of interest statement . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
⁎ Corresponding author. Fax: +1 919 843 5387. E-mail address: [email protected] (J.F. Boggess). 1 Fax: +1 919 843 5387. 2 Fax: +1 407 303 2435. 0090-8258/$ – see front matter © 2009 Published by Elsevier Inc. doi:10.1016/j.ygyno.2009.02.002
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Introduction Surgery is a controlled injury. In order to treat disease, surgeons balance complications and invasiveness with clinical outcomes in order to determine which techniques are best. Minimally invasive surgery (MIS) is a method to reduce the morbidity of surgery and has been shown in general to reduce blood loss, complications, postoperative pain and length of hospital stay compared with traditional laparotomy [1]. While laparoscopic tools have evolved significantly over the last three decades, there has not been widespread adoption in gynecology and gynecologic oncology [2,3]. The development and introduction of robotic assisted MIS addresses many of the limitations of traditional laparoscopy instruments by restoring dexterity and intuitive instrument movement, 3-D vision, ergonomics and autonomy. Although robotic surgery in gynecology is in its infancy, the use of the da Vinci surgical system is quickly becoming an integral tool for treating gynecologic malignancies [4]. Since 2005, robotic surgery has emerged as an effective MIS tool in gynecologic oncology that in early feasibility studies appears to decrease surgical morbidity beyond that seen with traditional laparoscopy [5–12]. The following review will outline the development of robotic surgical applications in gynecologic oncology and will describe the development of two successful robotic surgical programs – one university based and the other private practice based – in order to illustrate the specific issues inherent to both academic and private practice robotic surgery program development. Evolution of surgical robotics Historical perspectives The first surgical robots were utilized in the 1980s. The first surgical robots were industrial robots that were modified to assist with surgical procedures. In 1984 the PUMA-560, a revamped industrial robot, assisted with a stereotactic brain biopsy under CT guidance [13]. After the PUMA was used to assist with prostate surgery, further, specialized surgical robots were developed [14]. The PROBOT was developed in England specifically to assist in transurethral prostate surgery. The PROBOT had an ultrasonic tip, which allowed for reconstruction of the prostate and adequate removal of the organ [15]. Thus, prostatectomy is considered the first truly robotic operation. In the late 1980s, the ROBODOC was developed by Integrated Surgical Supplies, Inc. to specifically perform hip replacements (Fig. 1). ROBODOC was the first surgical robot approved by the FDA. Robotic surgery and tools for broader applications were further developed in the 1990s. Abdominal robotic assisted procedures
Fig. 1. ROBODOC developed by Integrated Surgical Supplies, Inc.
Fig. 2. Computer Motion's AESOP (Automatic Endoscopic System for Optimal Positioning) has allowed surgeons to control the orientation of the laparoscope via foot pedal and later voice commands, freeing both hands for surgery.
became possible with the advent of Computer Motion's AESOP (Automatic Endoscopic System for Optimal Positioning). In 1994, the first FDA approval of a robotic device for intra-abdominal surgery was granted. AESOP was a robotic arm that allowed surgeons to control the orientation of a traditional laparoscope via foot pedal and later voice command (Fig. 2). AESOP was the first voice-controlled robot to receive FDA approval. Four years later, Computer Motion introduced ZEUS, a second-generation robotic system. Zeus was the first robotic system to provide instrument control in addition to camera control. Zeus was composed of three robotic arms — one for a 2-dimensional laparoscope and two arms to control surgical instruments. The camera was operated with voice commands similar to AESOP while the surgeon controlled the instrument arms from a remote console. A computer translated the surgeon's movements into the laparoscopic instruments, which were scaled according to surgeon preference. The Zeus system had a 2D video screen identical to laparoscopy (Fig. 3).
Fig. 3. ZEUS robotic system; first robotic system to combine instrument and camera control.
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Fig. 4. Da Vinci Surgical System, Intuitive Surgical, Inc., Sunnyvale, CA.
Using the ZEUS robotic system, a remote-site robotic surgery was first performed by a surgeon in New York who performed a cholecystectomy on a patient in Strasbourg, France. This surgery utilized a dedicated fiber optic network and was performed after several similar trans-Atlantic surgeries had been performed on pigs [16]. Telesurgery has been limited due to bandwidth restraints and cost limitations. However, DARPA, the Defense Advanced Research Projects Agency, and TATRC, the U.S. Army Telemedicine and Advanced Technology Research center have led advancements in robotic telesurgery given the Congressional mandate to transform the Army to one-third unmanned vehicles by 2015. Around the time that ZEUS was being developed, Intuitive Surgical introduced the da Vinci robotic surgical system. The first telesurgery using the da Vinci robotic system was conducted via public-use internet between the University of Cincinnati and Intuitive Surgical in California in March 2006 [17]. The da Vinci surgical system is the only FDA approved robotic surgical system on the market currently, and will be further described below. The da Vinci surgical system The da Vinci surgical system is the most sophisticated of the surgical robotic systems. The da Vinci has three components: the patient side surgical cart, the vision system and the surgical console (Fig. 4). The patient side cart has three to four arms for controlling a 12 mm 3-dimensional camera and two or three robotic surgical instruments. The vision cart processes the video signal from the camera and the image displayed on the surgeon console and two separate monitors for the surgical assistant. Each eyepiece on the surgical console receives a different feed allowing reconstruction of the internal 3-dimensional view of the operative field. The surgeon sits remotely from the patient at the surgical console. The robotic instruments are controlled via the surgeon's fingers in two hand pieces or ‘masters’. The surgeon's movements are translated into the robotic surgical instruments, decreasing tremor and enhancing precision. Robotic instruments are uniquely wristed allowing seven degrees of freedom as opposed to the four degrees of freedom offered by traditional laparoscopic instruments. Foot controls allow the console surgeon to adjust the camera independently and activate monopolar and bipolar energy sources. A surgical assistant stands patient side to assist via traditional laparoscopic instruments. There are two da Vinci systems currently available; the standard and Ssystems. The standard system was developed first and has 3 or an optional 4th arm. The S-system was the next upgrade and has 3dimensional, high definition vision, a wider panoramic view, and a digital zoom that was developed to prevent instrument interference. An integrated touch screen LCD monitor is available with the S-system
that allows the bedside assistant to see what the surgeon sees. The monitor has a telestration feature (finger writing feature viewable by both the bedside assistant and the console surgeon) that allows for better proctoring and communication between the bedside assistant and the surgeon. Da Vinci surgical applications in gynecologic oncology In 1999, the cardiothoracic surgery team of Loulmet and colleagues performed one of the first procedures using the da Vinci surgical system. They described the use of robotic assistance in performing coronary artery bypass grafts and showed that patients who underwent robotic assistance had shorter length of stays in the hospital, and less time in the intensive case unit after surgery compared with sternotomy [18]. The use of the da Vinci robotic-assisted laparoscopic radical prostatectomy (RALP) was pivotal in bringing about the subsequent wide spread use of the tool in gynecology. In 2001, Binder et al. [19] published their first 10 cases of RALP. Since then, RALP has quickly moved to an accepted method treatment for prostate cancer. Most recently, a case series of 1500 patients of RALP they concluded that the procedure was safe, feasible, and efficacious [20]. Based upon the pioneering work of Advincula and Reynolds who reported on the use of the robot for myomectomies followed by their preliminary experience in staging gynecologic cancers the United States Food and Drug Administration (FDA) approved the use of the da Vinci in gynecologic procedures in April 2005 [21–24]. In February, 2006, Boggess performed the first live telecast demonstrating a technique for performing robotic assisted radical hysterectomy and subsequently presented data for a series of 13 radical hysterectomies at the Society of Gynecologic Oncologists annual meeting in March of the same year [25]. Since this initial demonstration of feasibility and technique, the interest in robotic assisted gynecologic oncology procedures has rapidly spread. Tables 1 and 2 summarize the current literature detailing experiences of robotic procedures for the Table 1 Robotic-assisted radical hysterectomy cases; N/A = not available Article
Year
# pts
Median operative time (min)
Median EBL (mL)
Median lymph node count
Marchal, et al. [29] Sert, et al. [28] Sert, et al. [27] Kim, et al. [8] Magrina, et al. [9] Fanning, et al. [26] Boggess, et al. [6]
2005 2006 2007 2008 2008 2008 2008
7 1 15 10 18 20 51
N/A N/A 241 207 226 390 211
N/A N/A 71 355 175 300 97
N/A N/A N/A 28 26 18 32
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Table 2 Robotic-assisted staging of endometrial cancer; N/A = not available Article
Year
# pts
Median operative time (min)
Median EBL (mL)
Mean total lymph node counts
Reynolds, et al. [24] Marchal, et al. [29] Bell, et al. [30] Denardis, et al. [7] Boggess, et al. [5]
2005 2005 2008 2008 2008
2 5 40 56 103
N/A N/A 184 177 191
N/A N/A 166 105 75
23 N/A 17 19 33
treatment of cervical and endometrial cancer. While these series are relatively small and non-randomized, they consistently demonstrate safety and efficacy with respect to complications, blood loss, operative time and patient convalescence compared with laparotomy and laparoscopy [8,9,26–28]. Rationale and strategic approach to program building — a tale of two programs Early adopters of robotic surgery have not only faced challenges in procedure development, but also in program development. There are inherent differences in program building based on the type of practice involved. As more gynecology oncologists begin to adopt robotic surgery, these early experiences can serve as a roadmap to establishing a successful program. Program initiation Program initiation is based on two key players: surgeons and administrators. Surgeon interest and commitment to a robotic program is key in the successful implementation, whereas administrators are paid to protect the financial interests of an institution and thus must be convinced that robotics offers benefits and is marketable. Cost The upfront capital investment for an institution is between $1,000,000 and $1,500,000 per da Vinci® surgical system and requires a 10% annual maintenance fee for repair and service as well as software upgrades to the system. There are also costs associated for each case that include robotic instrument use cost of $200 per use. Second, additional costs include drapes for the actual system, robot specific ports (depending on the type of system), and any other accessories necessary for the particular case. Third, there is the cost of training personnel to set up the system; initially there may be delays due to the novel nature of the process and may lead to additional operating room time and costs. Finally, there is the cost for proctoring newly involved surgeons in a program [4]. In the end, an institution must view the system as an investment that requires continued support by multiple services to ensure the program's success. The fixed cost of the system can be justified and distributed when utilized to a maximum number of cases by multiple surgical services.
Fig. 5. Growth of robotic assisted cases for the gynecology and gynecologic oncology services at UNC since the inception of the program in 2005; 2008⁎ represents data compiled through October 2008.
be beneficial and the initial system, a standard 3-arm robot was installed in February 2005. At the University of North Carolina, the Urology service was the first to use the robot. In 2005, the gynecologic oncology service performed the institution's first robotic hysterectomy and bilateral salpingoophorectomy. Since then, the number of gynecologic procedures performed has exceeded 700 cases. The initial success of the program led to the purchase of a second system (S-system); both systems are used virtually every day with access by five different surgical services. Robotic surgical procedures by the gynecology and gynecologic oncology services have grown progressively since the inception of the program in 2005 (Figs. 5 and 6), and the majority of staging for endometrial cancer and radical hysterectomy for cervical cancer are currently performed via robotic assistance. Private setting In contrast, the development of the robotics program at Florida Hospital in Orlando began in 2006 soon after seeing a live broadcast of a robotic radical hysterectomy [25]. As with many gynecology practices, a da Vinci system was already in place at the medical center being utilized by the Urology service. The evolution to robotics was viewed as particularly challenging by the attending surgeons since the gynecologic oncology program was not routinely performing minimally invasive surgical techniques for treatment gynecologic malignancies. Despite the ability to perform an open radical hysterectomy in 97 min and an endometrial staging in 84 min on average [7], the group decided to explore robotics in order to improve surgical outcomes for their patients. It was postulated that the quicker patient
Public institution experience At the publicly funded, University of North Carolina, surgeons pursued a robotic surgery program based on extensive experience in advanced laparoscopic surgery [4]. The University administration was interested in the financial aspects of establishing a robotic program; one key factor was use of the system by multiple surgical departments. At UNC, Urology offered initial interest, followed by pediatric and gynecologic oncology surgery. As a leading Universitybased academic program questions regarding the advantages of robotic assistance over laparoscopic techniques with regard to patient outcomes and learner experience were considered. Ultimately, surgeons and administration agreed that a robotic program would
Fig. 6. Cases performed by the gynecologic oncology service at UNC from 2005–2008; data from 2008 is compiled up to 6/30/2008.
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Fig. 7. Quarterly growth of robotic cases during the first two-years of robotics program at Florida Hospital— Orlando (6/30/06–6/30/08).
recovery times combined with less pain and complications would justify any anticipated increases in operative times. The purchase price of a da Vinci® system is significant to the budget of any hospital; however, it was anticipated that conversion of complicated gynecologic laparotomy cases to MIS would shorten length of stay, thus freeing up inpatient bed-days to satisfy the admission needs of the hospital. Ultimately, the potential improvement in patient outcomes from MIS compared to the standard laparotomy justified the hospital investment irrespective of the best and worst case economic projections. Since the program's inception, the number of cases performed robotically continues to grow each quarter, approaching 400 robotic procedures annually at present (Fig. 7).
Fig. 9. Changes in the pattern of surgery for endometrial cancer during the first twoyears of the program at Florida Hospital (2007–2008).
immersive vision were major improvements over traditional laparoscopy and that the system would be adequate for performing more complex procedures. Based upon this initial success, a robotic assisted endometrial cancer staging was performed the following week and a radical hysterectomy performed as case number three. Since this initial experience, the author has performed and/or instructed on over 600 robotic procedures with the emphasis being on hysterectomy, simple or radical, and lymph node dissection. Since the inception of the robotics program in gynecologic oncology at Florida Hospital, there has been consistent growth in the number of robotic cases performed each year (Fig. 8). Furthermore, there has been a shift in the trend of approach to endometrial cancer staging cases with now more than half of the cases being performed via robotic assistance (Fig. 9).
Training Teaching residents, fellows, and colleagues Regardless of setting, training of multiple team members must occur prior to procedure initiation. In both public and private experiences, a dedicated team of nurses and operating room support staff were trained on the operation of the system. Designated surgeons were oriented to the system in a “dry lab” setting and then attended a porcine lab for a one-day comprehensive training and certification course. In the academic setting, the first case was a simple hysterectomy and bilateral oophorectomy. The technique used was based upon a modified KOH ring method for performing total laparoscopic hysterectomy [29]. Port placement strategy for this first case was derived from the robotic assisted prostatectomy literature. The primary surgeon's perception was that the ergonomics and intuitive movements of the instruments combined with the 3-dimensional
Training of additional surgeons in robotic surgery has been crucial to the success of both public and private gynecologic oncology programs. The most successful training programs have utilized a process involving progressive involvement. At the start of both programs, a single surgeon developed procedures at the console with assistants at the bedside. Cases were scheduled according to the surgeon's level of comfort. With time, the involvement of assistants (residents and fellows) on the console increased. The observation of robotic cases by residents and fellows is important to familiarize them to the instrument. At UNC, residents/ fellows begin by learning the placement of trocars necessary for the particular case, followed by docking the robotic arms to the ports. It is also a goal for learners to gain the ability to trouble shoot the device/ arms during the case as this can make a major difference in the ability of the console surgeon to the effectively complete the case. Becoming familiar with the robot as the bedside surgeon also serves to teach the anatomy, surgical boundaries, and surgical procedures with vivid visualization. After case observation, residents and fellows train in the Table 3 Robotic surgical curriculum (adapted from Chitwood, et al. [32])
Fig. 8. Growth of gynecologic oncology robotic cases at Florida Hospital during the years 2006–2008 (⁎ = 8-month data).
1. Didactic overview Understanding robotic instrumentation 2. Inanimate lab Master console (actuators/pedals) 3. Animal lab Console surgeon— master suturing, tissue manipulation Patient side surgeon— master instrument changes, trocar positioning 4. Cadaver lab Master trocar placement Apply acquired skills to cadaver 5. Operative observation 6. Performance live case
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(dry) laboratory and practice specific tasks on the robot. The completion of such pre-surgical preparation is followed by performance of appropriate surgical procedures for patients under direct supervision. The da Vinci® S system has an LCD with writing feature allowing the bedside surgeon (attending) an opportunity to observe, teach, and guide the resident/fellow at the same time. Table 3 outlines a stepwise training strategy for robotic surgery.
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cost of training personnel to set up the system; initially there may be delays due to the novel nature of the process and may lead to additional operating room duration and costs. Finally, there is the cost for proctoring newly involved surgeons in a program [4]. In the end, an institution must view the system as an investment that requires continued support by multiple services to ensure the program's success. Strategies for building a robotic surgery team
Surgical skill-set requirements and strategies for acquisition and development The robotic surgical system is a tool set and, therefore, a successful procedure is dependent upon the surgeon's abilities. The primary goal when transitioning to robotics is to develop comfort and familiarity with the tools in order to have safe and efficient procedures. In our experience, there are multiple ways to obtain the skills necessary to become a successful robotic surgeon. One way is to participate in a dry (inanimate) lab session practicing suturing, and performing simple dexterity skills with the robotic surgical system. Furthermore, it is useful to participate in a formal porcine training lab in order to practice handling tissue, tissue dissection, cautery, and tissue resection to become proficient with the instrumentation. However, this has proven financially impractical for multiple residents. Finally, console experience with simple hysterectomies and salpingo-oophorectomy are the necessary predecessors to more complicated procedures. Thus far, at UNC, attending surgeons have logged over 400 h on the console since 2005 and fellows have logged almost 200 console hours. Teaching other physicians the use of the da Vinci surgical system can take several forms. Traditionally, educating other physician on surgical techniques involves direct case observation in the operating room. Direct case observation can prove very useful for surgeons who have never seen robotic surgery performed in a live setting. Intuitive Surgical has promotional material in DVD format of both an endometrial cancer staging operation and a radical hysterectomy with pelvic lymphadenectomy for cervical cancer that were developed by the senior author. Surgical symposia are another way to educate other physicians and ancillary personnel about robotic surgery. In 2007, UNC hosted the first International Gynecologic Oncology Robotic Symposium (IGORS). During this conference, attendees had the opportunity to see two live cases, hear a series of lectures on robotic surgery, experience and technique, and participate in discussion forums on previous experiences in robotics (difficult cases, complications, trouble-shooting tips etc.). Concept of a minimally invasive surgical team Institutional commitment There are currently over 600 da Vinci surgical systems installed in the United States; and over 900 systems around the world [30]. Since most gynecology robotics programs will be implemented at an institution already performing Urology or General Surgery cases, surgical teams familiar with the system typically already exist. There are, however, differences in gynecology that need to be taught. In this situation, the fixed cost of the system can be justified and distributed throughout the difference services and is determined according to the number of cases performed in total by all services using the robot. As previously mentioned, there is an up from cost through a capital investment between $1,000,000 and $1,500,000 per da Vinci surgical system in addition to the 10% annual maintenance fee for repair and service. There are also periodic software upgrades that are required to maintain the fluid function of the system. At $200 per use, the instruments also add a significant cost to the individual procedure and to the program as a whole. Furthermore, additional costs include drapes for the actual system, robot specific ports (depend on type of system), and any other accessories necessary for the particular case. There is the
Building a professional sports team requires money, a good head coach, and talented players. The same can be said about starting a robotic surgery program. Once the institution has decided to make the initial investment in a system, the next key step is to find a physician or small group of physicians within the institution who will take charge in building the program: a surgical champion. This individual should not only have the training necessary to operate the robot, but also the support of their respective departments. Often the start of a robotic program is met with resistance because initially the cases may take longer to complete, there may be high rates of conversion from robotic to open surgery, or there may be a lack of support from the operating room staff. Regardless, it is important for the robot program leader to assemble a team that will feel invested in the program and feel that the success of the program depends upon them. The robot team should consist of individuals that are open to change, are willing to learn a whole new instrument, and don't mind enduring the growing pains of implementing a new system. Establishing guidelines Patient selection Several considerations are involved when selecting the route of surgical intervention in patients with gynecologic malignancies. Factors to consider when choosing a robotic surgical approach may include disease type, extent of disease, preoperative imaging, stage, patient age, body mass index, parity, size of lesion(s), and equipment availability. There are currently no published guidelines on patient selection as it relates to robotic surgery in gynecology. In general, our institution has developed some general considerations when determining the use of robotics for patients with uterine or cervical cancer. In the preoperative period, patients receive imaging studies such as CT scans to assess for metastatic disease (as in the case of grade III or atypical uterine cancer), or MRI (to assess for parametrial involvement in the case of cervical cancer with large lesions). The size and weight of the patient often plays a limited role in the decision to proceed with robotic surgery. The main factor is the ability of the patient to tolerate steep Trendelenberg, which is necessary to complete the surgery. Patients with multiple (non-pulmonary) comorbidities need not be excluded from a robotic surgical approach if anesthesia clears them. Table 4 Abbreviated clinical pathway for robotic surgery in gynecologic oncology
Bowel preparation Preoperative Post operative laboratory Post-op diet Analgesia
Ambulation Catheter removal
Endometrial cancer
Cervical cancer
Golytelya Cefoxitin 2gm IV, no anticoagulant Hemoglobin/hematocrit on POD 1 Clear liquid when fully awake, regular diet after 8 h Oral narcotics preferred PRN, no standing order for IV narcotics post PACU Within 4 h When able to ambulate if no bladder trauma
Same Same Same Same Same
Same POD 4–7
a Can substitute magnesium citrate (POD = post operative day, PACU = post anesthesia care unit).
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Protocols, algorithms, clinical pathways Clinical pathways are used to streamline and standardize postoperative care. These pathways are prevalent in the general surgery literature for MIS operations such as appendectomy, cholecystectomy, and increasingly gastric bypass [31–33]. At UNC, our clinical pathway since 2005 allows patients to quickly recover after anesthesia, ambulate, eat, and be discharged from the hospital within 24 h (Table 4). The clinical pathway was duplicated at Florida Hospital with similar success. In both institutions this has led to more efficient utilization of hospital resources without compromising patient care. Patients do not have a standing order for intravenous narcotics once they leave the post anesthesia care unit (PACU). Patients requesting intravenous pain medication are assessed by a physician then given the appropriate medication to provide the appropriate analgesia. We find this is important since excessive and inappropriate pain after minimally invasive surgery may potentially be a sign of an acute abdominal process. Clinical outcomes Since 2005 there has been an increase in the published literature describing outcomes for robotic surgery in gynecologic oncology. Marchal et al.[34] in 2005 first described their experience with hysterectomy, endometrial cancer staging, and radical hysterectomy Piver type II for cervical cancer. They reported only one conversion to laparotomy out of 30 cases; 17% post-operative complication rate, less intra-operative bleeding, less pain, and a shorter hospital stay. Reynolds has since echoed these outcomes as they reported on their initial 7 cases. Post operative results demonstrated excellent lymph node retrieval (average 15 lymph nodes), a blood loss of 50 mL, and a median length of stay of 2 days and no conversions to laparotomy [24]. Sert and Abeler published the results on a series of 15 patients relating to outcomes from robotic assisted radical hysterectomy compared to laparoscopy. In their cohort, the robotic assisted group has less operative times, less bleeding, and a shorter hospital stay compared to traditional laparoscopy [27]. Another paper dealing with outcomes was from Kim et al. where they reported on 10 patients who underwent robotic radical hysterectomy. The average estimated blood loss for the 10 cases was 355 mL and their complication rate was low [8]. Magrina [9] and Fanning [26] have also reported their outcomes with robotic radical hysterectomy. In both studies the median case blood loss was less than 300 mL and the median lymph count was 26 and 18 total pelvic lymph nodes, respectively. In the current largest series by Boggess et al. [6], 51 patients underwent robotic assisted radical hysterectomy with pelvic lymphadenectomy. This cohort of patients had low median blood loss (97 mL), operative time, and a high lymph node count. One of the most distinguishing findings was that the median length of stay was 1 day in robotic cohort compared to 3 days for the comparable open cohort. Staging for endometrial cancer via robotic assistance is also gaining acceptance. Laparoscopic surgical staging has generally led to lower blood loss, less post-operative pain, and shorter length of stay. There has been a single prospective randomized trial assessing the feasibility of laparoscopy for endometrial cancer staging (Gynecologic Oncology Group Lap-2). In this study of over 2000 women, the results showed the procedure was feasible with an average hospital stay of 3 days and a conversion rate of 23% [35]. Since 2005 there have been reports detailing the use of the robot for the staging of endometrial cancer. All reports described shorter operative times, shorter length of stays, and lower estimated blood loss [6,36]. To date, Boggess and colleagues have reported on the largest cohort of patients undergoing robotic endometrial cancer staging (see Table 2). The reported median lymph node retrieval of 33 nodes was also the largest count achieved to date. In their first year's experience, the Florida Hospital group reported a significant reduction in peri-operative morbidity with the
initiation of robotic surgery compared to laparotomy [7]. These studies point the reproducibility and feasibility of the procedure. Summary The development of surgical robots is revolutionizing surgery in gynecologic oncology just as it has done for urology and cardiothoracic surgery. With improvements in operative times, decreased blood loss, and decrease in length of stay after surgery, the robot has allowed surgeons to perform more and more complex procedures, while providing patients the benefits of minimally invasive surgery. Endometrial cancer staging and radical hysterectomy have emerged as the most common gynecologic oncology procedures performed using robotic assistance. Over 1000 systems have been installed worldwide and the use of the robot continues to increase. Community based practices and university based institutions are increasingly adopting the use of the robot and its use continues to expand. In this review, we have outlined templates for the successful initiation of a robotic surgery program in both an academic and private setting, and have discussed many facets of program development and surgeon training. Today, robotic surgery has introduced precision, autonomy, ergonomics and efficiency to minimally invasive surgery. Tomorrow, with development, computers and robots will enhance our abilities beyond what can be achieved or imagined today. It will be our responsibility as surgeons to critically evaluate these new developments in the context of our patients to ensure the best clinical outcomes. Conflict of interest statement Alberto Mendivil, MD has no conflict of interest to declare. Robert W. Holloway, MD is a consultant for Intuitive Surgical. John F. Boggess, MD is a consultant for Intuitive Surgical.
References [1] Abaid LN, Boggess JF. Current applications of laparoscopy in gynecologic oncology: a literature review. Women's Oncol Rev [Review] 2005;5(4):193–201. [2] Naumann RW, Coleman RL. The use of adjuvant radiation therapy in early endometrial cancer by members of the Society of Gynecologic Oncologists in 2005. Gynecol Oncol 2007 Apr;105(1):7–12. [3] Visco AG, Barber MD, Myers ER. Early physician experience with laparoscopically assisted vaginal hysterectomy and rates of surgical complications and conversion to laparotomy. Am J Obstet Gynecol 2002 Oct;187(4):1008–12. [4] Boggess JF. Robotic surgery in gynecologic oncology: evolution of a new surgical paradigm. J Robot Surg [review article] 2007 2/28/2007;1(1):31–7. [5] Boggess JF, Gehrig PA, Cantrell L, Shafer A, Ridgway M, Skinner EN, et al. A comparative study of 3 surgical methods for hysterectomy with staging for endometrial cancer: robotic assistance, laparoscopy, laparotomy. Am J Obstet Gynecol 2008 Oct;199(4):360 e1–9. [6] Boggess JF, Gehrig PA, Cantrell L, Shafer A, Ridgway M, Skinner EN, et al. A casecontrol study of robot-assisted type III radical hysterectomy with pelvic lymph node dissection compared with open radical hysterectomy. Am J Obstet Gynecol. 2008 Oct;199(4):357 e1–7. [7] Denardis SA, Holloway RW, Bigsby GEt, Pikaart DP, Ahmad S, Finkler NJ. Robotically assisted laparoscopic hysterectomy versus total abdominal hysterectomy and lymphadenectomy for endometrial cancer. Gynecol Oncol 2008 Dec 1. [8] Kim YT, Kim SW, Hyung WJ, Lee SJ, Nam EJ, Lee WJ. Robotic radical hysterectomy with pelvic lymphadenectomy for cervical carcinoma: a pilot study. Gynecol Oncol 2008 Feb;108(2):312–6. [9] Magrina JF, Kho RM, Weaver AL, Montero RP, Magtibay PM. Robotic radical hysterectomy: comparison with laparoscopy and laparotomy. Gynecol Oncol 2008 Apr;109(1):86–91. [10] Payne TN, Dauterive FR. A comparison of total laparoscopic hysterectomy to robotically assisted hysterectomy: surgical outcomes in a community practice. J Minim Invasive Gynecol 2008 May–Jun;15(3):286–91. [11] Shafer A, Boggess JF. Robotic-assisted endometrial cancer staging and radical hysterectomy with the da Vinci surgical system. Gynecol Oncol 2008 Nov;111 (2 Suppl):S18–23. [12] Veljovich DS, Paley PJ, Drescher CW, Everett EN, Shah C, Peters WA 3rd. Robotic surgery in gynecologic oncology: program initiation and outcomes after the first year with comparison with laparotomy for endometrial cancer staging. Am J Obstet Gynecol 2008 Jun;198(6):679 e1–9; discussion e9–10. [13] 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 Feb;35(2):153–60. [14] Davies BL, Hibberd RD, Ng WS, Timoney AG, Wickham JE. The development of a surgeon robot for prostatectomies. Proc Inst Mech Eng [H] 1991;205(1):35–8.
A. Mendivil et al. / Gynecologic Oncology 114 (2009) S24–S31 [15] Harris SJ, Arambula-Cosio F, Mei Q, Hibberd RD, Davies BL, Wickham JE, et al. The Probot–an active robot for prostate resection. Proc Inst Mech Eng [H] 1997;211 (4):317–25. [16] Marescaux J, Leroy J, Gagner M, Rubino F, Mutter D, Vix M, et al. Transatlantic robot-assisted telesurgery. Nature 2001 Sep 27;413(6854):379–80. [17] Romano Jr JA, Lam DM, Moses GR, Gilbert GR, Marchessault Jr R. The future of military medicine has not arrived yet, but we can see it from here. Telemed J E Health 2006 Aug;12(4):417–25. [18] Loulmet D, Carpentier A, d'Attellis N, Berrebi A, Cardon C, Ponzio O, et al. Endoscopic coronary artery bypass grafting with the aid of robotic assisted instruments. J Thorac Cardiovasc Surg 1999 Jul;118(1):4–10. [19] Binder J, Kramer W. Robotically-assisted laparoscopic radical prostatectomy. BJU Int 2001 Mar;87(4):408–10. [20] Patel VR, Palmer KJ, Coughlin G, Samavedi S. Robot-assisted laparoscopic radical prostatectomy: perioperative outcomes of 1500 cases. J Endourol 2008 Oct;22 (10):2299–305. [21] Advincula AP, Reynolds RK. The use of robot-assisted laparoscopic hysterectomy in the patient with a scarred or obliterated anterior cul-de-sac. JSLS 2005 Jul–Sep;9 (3):287–91. [22] Advincula AP, Song A, Burke W, Reynolds RK. Preliminary experience with robot-assisted laparoscopic myomectomy. J Am Assoc Gynecol Laparosc 2004 Nov;11(4):511–8. [23] Reynolds RK, Advincula AP. Robot-assisted laparoscopic hysterectomy: technique and initial experience. Am J Surg 2006 Apr;191(4):555–60. [24] Reynolds RK, Burke WM, Advincula AP. Preliminary experience with robot-assisted laparoscopic staging of gynecologic malignancies. JSLS 2005 Apr–Jun;9(2):149–58. [25] Boggess JF. Robotic-assisted radical hysterectomy for cervical cancer: National Library of Medicine Archives. 2006 [updated 2006; cited 2008 11/08/2008]; Available from: http://www.nlm.nih.gov/medlineplus/surgeryvideos.html. [26] Fanning J, Fenton B, Purohit M. Robotic radical hysterectomy. Am J Obstet Gynecol 2008 Jun;198(6):649 e1–4.
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[27] Sert B, Abeler V. Robotic radical hysterectomy in early-stage cervical carcinoma patients, comparing results with total laparoscopic radical hysterectomy cases. The future is now? Int J Med Robot 2007 Sep;3(3):224–8. [28] Sert BM, Abeler VM. Robotic-assisted laparoscopic radical hysterectomy (Piver type III) with pelvic node dissection—case report. Eur J Gynaecol Oncol 2006;27 (5):531–3. [29] Koh CH. A new technique and system for simplifying total laparoscopic hysterectomy. J Am Assoc Gynecol Laparosc 1998 May;5(2):187–92. [30] IntuitiveSurgical. Intuitive Surgical company profile. Sunnyvale, CA; 2008 [updated 2008; cited 2008 September 29, 2008]; Available from: http://www.intuitivesurgical.com/corporate/companyprofile/index.aspx. [31] Soria V, Pellicer E, Flores B, Carrasco M, Candel Maria F, Aguayo JL. Evaluation of the clinical pathway for laparoscopic cholecystectomy. Am Surg 2005 Jan;71 (1):40–5. [32] Almond SL, Roberts M, Joesbury V, Mon S, Smith J, Ledwidge N, et al. It is not what you do, it is the way that you do it: impact of a care pathway for appendicitis. J Pediatr Surg 2008 Feb;43(2):315–9. [33] Campillo-Soto A, Martin-Lorenzo JG, Liron-Ruiz R, Torralba-Martinez JA, BentoGerard M, Flores-Pastor B, et al. Evaluation of the clinical pathway for laparoscopic bariatric surgery. Obes Surg 2008 Apr;18(4):395–400. [34] Marchal F, Rauch P, Vandromme J, Laurent I, Lobontiu A, Ahcel B, et al. Telerobotic-assisted laparoscopic hysterectomy for benign and oncologic pathologies: initial clinical experience with 30 patients. Surg Endosc 2005 Jun;19(6):826–31. [35] Walker J. Phase III trial of laparoscopy (scope) vs TAH (open) for surgical resection and comprehensive surgical staging of uterine cancer: a Gynecologic Oncology Group (GOG) study funded by NCI. Gynecol Oncol 2006;101(1):S2–S11. [36] Pikaart DP, Holloway RW, Ahmad S, Finkler NJ, Bigsby GEt, Ortiz BH, et al. Clinicalpathologic and morbidity analyses of Types 2 and 3 abdominal radical hysterectomy for cervical cancer. Gynecol Oncol 2007 Nov;107(2):205–10.
Contents lists available at ScienceDirect
Gynecologic Oncology j o u r n a l h o m e p a g e : w w w. e l s e v i e r. c o m / l o c a t e / y g y n o
Review
Emergence of robotic assisted surgery in gynecologic oncology: American perspective Alberto Mendivil a,1, Robert W. Holloway b,2, John F. Boggess a,⁎ a University of North Carolina, Chapel Hill, Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, 101 Manning Drive, CB 7572, Chapel Hill, NC 27599-7572. USA b Gynecologic Oncology Program, Florida Hospital Cancer Institute, 2501 N. Orange Avenue, Suite 689, Orlando, FL 32804, USA
a r t i c l e
i n f o
Article history: Received 21 November 2008 Keywords: Robotics Endometrial cancer Cervical cancer da Vinci
a b s t r a c t Objectives. To discuss the emergence of robotic surgery in gynecologic oncology and describe the growth of robotic surgery in a university medical center and a community based practice. Methods. In addition to the historical evolution of the robotic assisted surgery medicine, a survey of robotic cases was performed on two robotic programs since the inception of the programs. A review of the current literature on the use of the da Vinci robot in gynecologic oncology was also performed. Results. The robotic surgery programs at UNC Hospital and Florida Hospital are growing steadily since the inception of the programs in 2005 and 2006, respectively. Since 2005 there have also been numerous publications detailing the effectiveness, safety, and efficiency of the robot. Conclusions. Robotic surgery is gaining acceptance and is rapidly growing as evidenced by an increased number of publications on the topic; these publications demonstrate the safety, efficacy, and improved outcomes compared to open surgery and conventional laparoscopy. © 2009 Published by Elsevier Inc.
Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Evolution of surgical robotics . . . . . . . . . . . . . . . . . . . . . . . . Historical perspectives. . . . . . . . . . . . . . . . . . . . . . . . . . The da Vinci surgical system . . . . . . . . . . . . . . . . . . . . . . . . . Da Vinci surgical applications in gynecologic oncology . . . . . . . . . . . . Rationale and strategic approach to program building — a tale of two programs Program initiation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Public institution experience . . . . . . . . . . . . . . . . . . . . . . . Private setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Teaching residents, fellows, and colleagues . . . . . . . . . . . . . . . . . . Surgical skill-set requirements and strategies for acquisition and development . Concept of a minimally invasive surgical team . . . . . . . . . . . . . . . . Institutional commitment . . . . . . . . . . . . . . . . . . . . . . . . Strategies for building a robotic surgery team . . . . . . . . . . . . . . . . . Establishing guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . Patient selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . Protocols, algorithms, clinical pathways. . . . . . . . . . . . . . . . . . Clinical outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conflict of interest statement . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
⁎ Corresponding author. Fax: +1 919 843 5387. E-mail address: [email protected] (J.F. Boggess). 1 Fax: +1 919 843 5387. 2 Fax: +1 407 303 2435. 0090-8258/$ – see front matter © 2009 Published by Elsevier Inc. doi:10.1016/j.ygyno.2009.02.002
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Introduction Surgery is a controlled injury. In order to treat disease, surgeons balance complications and invasiveness with clinical outcomes in order to determine which techniques are best. Minimally invasive surgery (MIS) is a method to reduce the morbidity of surgery and has been shown in general to reduce blood loss, complications, postoperative pain and length of hospital stay compared with traditional laparotomy [1]. While laparoscopic tools have evolved significantly over the last three decades, there has not been widespread adoption in gynecology and gynecologic oncology [2,3]. The development and introduction of robotic assisted MIS addresses many of the limitations of traditional laparoscopy instruments by restoring dexterity and intuitive instrument movement, 3-D vision, ergonomics and autonomy. Although robotic surgery in gynecology is in its infancy, the use of the da Vinci surgical system is quickly becoming an integral tool for treating gynecologic malignancies [4]. Since 2005, robotic surgery has emerged as an effective MIS tool in gynecologic oncology that in early feasibility studies appears to decrease surgical morbidity beyond that seen with traditional laparoscopy [5–12]. The following review will outline the development of robotic surgical applications in gynecologic oncology and will describe the development of two successful robotic surgical programs – one university based and the other private practice based – in order to illustrate the specific issues inherent to both academic and private practice robotic surgery program development. Evolution of surgical robotics Historical perspectives The first surgical robots were utilized in the 1980s. The first surgical robots were industrial robots that were modified to assist with surgical procedures. In 1984 the PUMA-560, a revamped industrial robot, assisted with a stereotactic brain biopsy under CT guidance [13]. After the PUMA was used to assist with prostate surgery, further, specialized surgical robots were developed [14]. The PROBOT was developed in England specifically to assist in transurethral prostate surgery. The PROBOT had an ultrasonic tip, which allowed for reconstruction of the prostate and adequate removal of the organ [15]. Thus, prostatectomy is considered the first truly robotic operation. In the late 1980s, the ROBODOC was developed by Integrated Surgical Supplies, Inc. to specifically perform hip replacements (Fig. 1). ROBODOC was the first surgical robot approved by the FDA. Robotic surgery and tools for broader applications were further developed in the 1990s. Abdominal robotic assisted procedures
Fig. 1. ROBODOC developed by Integrated Surgical Supplies, Inc.
Fig. 2. Computer Motion's AESOP (Automatic Endoscopic System for Optimal Positioning) has allowed surgeons to control the orientation of the laparoscope via foot pedal and later voice commands, freeing both hands for surgery.
became possible with the advent of Computer Motion's AESOP (Automatic Endoscopic System for Optimal Positioning). In 1994, the first FDA approval of a robotic device for intra-abdominal surgery was granted. AESOP was a robotic arm that allowed surgeons to control the orientation of a traditional laparoscope via foot pedal and later voice command (Fig. 2). AESOP was the first voice-controlled robot to receive FDA approval. Four years later, Computer Motion introduced ZEUS, a second-generation robotic system. Zeus was the first robotic system to provide instrument control in addition to camera control. Zeus was composed of three robotic arms — one for a 2-dimensional laparoscope and two arms to control surgical instruments. The camera was operated with voice commands similar to AESOP while the surgeon controlled the instrument arms from a remote console. A computer translated the surgeon's movements into the laparoscopic instruments, which were scaled according to surgeon preference. The Zeus system had a 2D video screen identical to laparoscopy (Fig. 3).
Fig. 3. ZEUS robotic system; first robotic system to combine instrument and camera control.
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Fig. 4. Da Vinci Surgical System, Intuitive Surgical, Inc., Sunnyvale, CA.
Using the ZEUS robotic system, a remote-site robotic surgery was first performed by a surgeon in New York who performed a cholecystectomy on a patient in Strasbourg, France. This surgery utilized a dedicated fiber optic network and was performed after several similar trans-Atlantic surgeries had been performed on pigs [16]. Telesurgery has been limited due to bandwidth restraints and cost limitations. However, DARPA, the Defense Advanced Research Projects Agency, and TATRC, the U.S. Army Telemedicine and Advanced Technology Research center have led advancements in robotic telesurgery given the Congressional mandate to transform the Army to one-third unmanned vehicles by 2015. Around the time that ZEUS was being developed, Intuitive Surgical introduced the da Vinci robotic surgical system. The first telesurgery using the da Vinci robotic system was conducted via public-use internet between the University of Cincinnati and Intuitive Surgical in California in March 2006 [17]. The da Vinci surgical system is the only FDA approved robotic surgical system on the market currently, and will be further described below. The da Vinci surgical system The da Vinci surgical system is the most sophisticated of the surgical robotic systems. The da Vinci has three components: the patient side surgical cart, the vision system and the surgical console (Fig. 4). The patient side cart has three to four arms for controlling a 12 mm 3-dimensional camera and two or three robotic surgical instruments. The vision cart processes the video signal from the camera and the image displayed on the surgeon console and two separate monitors for the surgical assistant. Each eyepiece on the surgical console receives a different feed allowing reconstruction of the internal 3-dimensional view of the operative field. The surgeon sits remotely from the patient at the surgical console. The robotic instruments are controlled via the surgeon's fingers in two hand pieces or ‘masters’. The surgeon's movements are translated into the robotic surgical instruments, decreasing tremor and enhancing precision. Robotic instruments are uniquely wristed allowing seven degrees of freedom as opposed to the four degrees of freedom offered by traditional laparoscopic instruments. Foot controls allow the console surgeon to adjust the camera independently and activate monopolar and bipolar energy sources. A surgical assistant stands patient side to assist via traditional laparoscopic instruments. There are two da Vinci systems currently available; the standard and Ssystems. The standard system was developed first and has 3 or an optional 4th arm. The S-system was the next upgrade and has 3dimensional, high definition vision, a wider panoramic view, and a digital zoom that was developed to prevent instrument interference. An integrated touch screen LCD monitor is available with the S-system
that allows the bedside assistant to see what the surgeon sees. The monitor has a telestration feature (finger writing feature viewable by both the bedside assistant and the console surgeon) that allows for better proctoring and communication between the bedside assistant and the surgeon. Da Vinci surgical applications in gynecologic oncology In 1999, the cardiothoracic surgery team of Loulmet and colleagues performed one of the first procedures using the da Vinci surgical system. They described the use of robotic assistance in performing coronary artery bypass grafts and showed that patients who underwent robotic assistance had shorter length of stays in the hospital, and less time in the intensive case unit after surgery compared with sternotomy [18]. The use of the da Vinci robotic-assisted laparoscopic radical prostatectomy (RALP) was pivotal in bringing about the subsequent wide spread use of the tool in gynecology. In 2001, Binder et al. [19] published their first 10 cases of RALP. Since then, RALP has quickly moved to an accepted method treatment for prostate cancer. Most recently, a case series of 1500 patients of RALP they concluded that the procedure was safe, feasible, and efficacious [20]. Based upon the pioneering work of Advincula and Reynolds who reported on the use of the robot for myomectomies followed by their preliminary experience in staging gynecologic cancers the United States Food and Drug Administration (FDA) approved the use of the da Vinci in gynecologic procedures in April 2005 [21–24]. In February, 2006, Boggess performed the first live telecast demonstrating a technique for performing robotic assisted radical hysterectomy and subsequently presented data for a series of 13 radical hysterectomies at the Society of Gynecologic Oncologists annual meeting in March of the same year [25]. Since this initial demonstration of feasibility and technique, the interest in robotic assisted gynecologic oncology procedures has rapidly spread. Tables 1 and 2 summarize the current literature detailing experiences of robotic procedures for the Table 1 Robotic-assisted radical hysterectomy cases; N/A = not available Article
Year
# pts
Median operative time (min)
Median EBL (mL)
Median lymph node count
Marchal, et al. [29] Sert, et al. [28] Sert, et al. [27] Kim, et al. [8] Magrina, et al. [9] Fanning, et al. [26] Boggess, et al. [6]
2005 2006 2007 2008 2008 2008 2008
7 1 15 10 18 20 51
N/A N/A 241 207 226 390 211
N/A N/A 71 355 175 300 97
N/A N/A N/A 28 26 18 32
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Table 2 Robotic-assisted staging of endometrial cancer; N/A = not available Article
Year
# pts
Median operative time (min)
Median EBL (mL)
Mean total lymph node counts
Reynolds, et al. [24] Marchal, et al. [29] Bell, et al. [30] Denardis, et al. [7] Boggess, et al. [5]
2005 2005 2008 2008 2008
2 5 40 56 103
N/A N/A 184 177 191
N/A N/A 166 105 75
23 N/A 17 19 33
treatment of cervical and endometrial cancer. While these series are relatively small and non-randomized, they consistently demonstrate safety and efficacy with respect to complications, blood loss, operative time and patient convalescence compared with laparotomy and laparoscopy [8,9,26–28]. Rationale and strategic approach to program building — a tale of two programs Early adopters of robotic surgery have not only faced challenges in procedure development, but also in program development. There are inherent differences in program building based on the type of practice involved. As more gynecology oncologists begin to adopt robotic surgery, these early experiences can serve as a roadmap to establishing a successful program. Program initiation Program initiation is based on two key players: surgeons and administrators. Surgeon interest and commitment to a robotic program is key in the successful implementation, whereas administrators are paid to protect the financial interests of an institution and thus must be convinced that robotics offers benefits and is marketable. Cost The upfront capital investment for an institution is between $1,000,000 and $1,500,000 per da Vinci® surgical system and requires a 10% annual maintenance fee for repair and service as well as software upgrades to the system. There are also costs associated for each case that include robotic instrument use cost of $200 per use. Second, additional costs include drapes for the actual system, robot specific ports (depending on the type of system), and any other accessories necessary for the particular case. Third, there is the cost of training personnel to set up the system; initially there may be delays due to the novel nature of the process and may lead to additional operating room time and costs. Finally, there is the cost for proctoring newly involved surgeons in a program [4]. In the end, an institution must view the system as an investment that requires continued support by multiple services to ensure the program's success. The fixed cost of the system can be justified and distributed when utilized to a maximum number of cases by multiple surgical services.
Fig. 5. Growth of robotic assisted cases for the gynecology and gynecologic oncology services at UNC since the inception of the program in 2005; 2008⁎ represents data compiled through October 2008.
be beneficial and the initial system, a standard 3-arm robot was installed in February 2005. At the University of North Carolina, the Urology service was the first to use the robot. In 2005, the gynecologic oncology service performed the institution's first robotic hysterectomy and bilateral salpingoophorectomy. Since then, the number of gynecologic procedures performed has exceeded 700 cases. The initial success of the program led to the purchase of a second system (S-system); both systems are used virtually every day with access by five different surgical services. Robotic surgical procedures by the gynecology and gynecologic oncology services have grown progressively since the inception of the program in 2005 (Figs. 5 and 6), and the majority of staging for endometrial cancer and radical hysterectomy for cervical cancer are currently performed via robotic assistance. Private setting In contrast, the development of the robotics program at Florida Hospital in Orlando began in 2006 soon after seeing a live broadcast of a robotic radical hysterectomy [25]. As with many gynecology practices, a da Vinci system was already in place at the medical center being utilized by the Urology service. The evolution to robotics was viewed as particularly challenging by the attending surgeons since the gynecologic oncology program was not routinely performing minimally invasive surgical techniques for treatment gynecologic malignancies. Despite the ability to perform an open radical hysterectomy in 97 min and an endometrial staging in 84 min on average [7], the group decided to explore robotics in order to improve surgical outcomes for their patients. It was postulated that the quicker patient
Public institution experience At the publicly funded, University of North Carolina, surgeons pursued a robotic surgery program based on extensive experience in advanced laparoscopic surgery [4]. The University administration was interested in the financial aspects of establishing a robotic program; one key factor was use of the system by multiple surgical departments. At UNC, Urology offered initial interest, followed by pediatric and gynecologic oncology surgery. As a leading Universitybased academic program questions regarding the advantages of robotic assistance over laparoscopic techniques with regard to patient outcomes and learner experience were considered. Ultimately, surgeons and administration agreed that a robotic program would
Fig. 6. Cases performed by the gynecologic oncology service at UNC from 2005–2008; data from 2008 is compiled up to 6/30/2008.
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Fig. 7. Quarterly growth of robotic cases during the first two-years of robotics program at Florida Hospital— Orlando (6/30/06–6/30/08).
recovery times combined with less pain and complications would justify any anticipated increases in operative times. The purchase price of a da Vinci® system is significant to the budget of any hospital; however, it was anticipated that conversion of complicated gynecologic laparotomy cases to MIS would shorten length of stay, thus freeing up inpatient bed-days to satisfy the admission needs of the hospital. Ultimately, the potential improvement in patient outcomes from MIS compared to the standard laparotomy justified the hospital investment irrespective of the best and worst case economic projections. Since the program's inception, the number of cases performed robotically continues to grow each quarter, approaching 400 robotic procedures annually at present (Fig. 7).
Fig. 9. Changes in the pattern of surgery for endometrial cancer during the first twoyears of the program at Florida Hospital (2007–2008).
immersive vision were major improvements over traditional laparoscopy and that the system would be adequate for performing more complex procedures. Based upon this initial success, a robotic assisted endometrial cancer staging was performed the following week and a radical hysterectomy performed as case number three. Since this initial experience, the author has performed and/or instructed on over 600 robotic procedures with the emphasis being on hysterectomy, simple or radical, and lymph node dissection. Since the inception of the robotics program in gynecologic oncology at Florida Hospital, there has been consistent growth in the number of robotic cases performed each year (Fig. 8). Furthermore, there has been a shift in the trend of approach to endometrial cancer staging cases with now more than half of the cases being performed via robotic assistance (Fig. 9).
Training Teaching residents, fellows, and colleagues Regardless of setting, training of multiple team members must occur prior to procedure initiation. In both public and private experiences, a dedicated team of nurses and operating room support staff were trained on the operation of the system. Designated surgeons were oriented to the system in a “dry lab” setting and then attended a porcine lab for a one-day comprehensive training and certification course. In the academic setting, the first case was a simple hysterectomy and bilateral oophorectomy. The technique used was based upon a modified KOH ring method for performing total laparoscopic hysterectomy [29]. Port placement strategy for this first case was derived from the robotic assisted prostatectomy literature. The primary surgeon's perception was that the ergonomics and intuitive movements of the instruments combined with the 3-dimensional
Training of additional surgeons in robotic surgery has been crucial to the success of both public and private gynecologic oncology programs. The most successful training programs have utilized a process involving progressive involvement. At the start of both programs, a single surgeon developed procedures at the console with assistants at the bedside. Cases were scheduled according to the surgeon's level of comfort. With time, the involvement of assistants (residents and fellows) on the console increased. The observation of robotic cases by residents and fellows is important to familiarize them to the instrument. At UNC, residents/ fellows begin by learning the placement of trocars necessary for the particular case, followed by docking the robotic arms to the ports. It is also a goal for learners to gain the ability to trouble shoot the device/ arms during the case as this can make a major difference in the ability of the console surgeon to the effectively complete the case. Becoming familiar with the robot as the bedside surgeon also serves to teach the anatomy, surgical boundaries, and surgical procedures with vivid visualization. After case observation, residents and fellows train in the Table 3 Robotic surgical curriculum (adapted from Chitwood, et al. [32])
Fig. 8. Growth of gynecologic oncology robotic cases at Florida Hospital during the years 2006–2008 (⁎ = 8-month data).
1. Didactic overview Understanding robotic instrumentation 2. Inanimate lab Master console (actuators/pedals) 3. Animal lab Console surgeon— master suturing, tissue manipulation Patient side surgeon— master instrument changes, trocar positioning 4. Cadaver lab Master trocar placement Apply acquired skills to cadaver 5. Operative observation 6. Performance live case
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(dry) laboratory and practice specific tasks on the robot. The completion of such pre-surgical preparation is followed by performance of appropriate surgical procedures for patients under direct supervision. The da Vinci® S system has an LCD with writing feature allowing the bedside surgeon (attending) an opportunity to observe, teach, and guide the resident/fellow at the same time. Table 3 outlines a stepwise training strategy for robotic surgery.
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cost of training personnel to set up the system; initially there may be delays due to the novel nature of the process and may lead to additional operating room duration and costs. Finally, there is the cost for proctoring newly involved surgeons in a program [4]. In the end, an institution must view the system as an investment that requires continued support by multiple services to ensure the program's success. Strategies for building a robotic surgery team
Surgical skill-set requirements and strategies for acquisition and development The robotic surgical system is a tool set and, therefore, a successful procedure is dependent upon the surgeon's abilities. The primary goal when transitioning to robotics is to develop comfort and familiarity with the tools in order to have safe and efficient procedures. In our experience, there are multiple ways to obtain the skills necessary to become a successful robotic surgeon. One way is to participate in a dry (inanimate) lab session practicing suturing, and performing simple dexterity skills with the robotic surgical system. Furthermore, it is useful to participate in a formal porcine training lab in order to practice handling tissue, tissue dissection, cautery, and tissue resection to become proficient with the instrumentation. However, this has proven financially impractical for multiple residents. Finally, console experience with simple hysterectomies and salpingo-oophorectomy are the necessary predecessors to more complicated procedures. Thus far, at UNC, attending surgeons have logged over 400 h on the console since 2005 and fellows have logged almost 200 console hours. Teaching other physicians the use of the da Vinci surgical system can take several forms. Traditionally, educating other physician on surgical techniques involves direct case observation in the operating room. Direct case observation can prove very useful for surgeons who have never seen robotic surgery performed in a live setting. Intuitive Surgical has promotional material in DVD format of both an endometrial cancer staging operation and a radical hysterectomy with pelvic lymphadenectomy for cervical cancer that were developed by the senior author. Surgical symposia are another way to educate other physicians and ancillary personnel about robotic surgery. In 2007, UNC hosted the first International Gynecologic Oncology Robotic Symposium (IGORS). During this conference, attendees had the opportunity to see two live cases, hear a series of lectures on robotic surgery, experience and technique, and participate in discussion forums on previous experiences in robotics (difficult cases, complications, trouble-shooting tips etc.). Concept of a minimally invasive surgical team Institutional commitment There are currently over 600 da Vinci surgical systems installed in the United States; and over 900 systems around the world [30]. Since most gynecology robotics programs will be implemented at an institution already performing Urology or General Surgery cases, surgical teams familiar with the system typically already exist. There are, however, differences in gynecology that need to be taught. In this situation, the fixed cost of the system can be justified and distributed throughout the difference services and is determined according to the number of cases performed in total by all services using the robot. As previously mentioned, there is an up from cost through a capital investment between $1,000,000 and $1,500,000 per da Vinci surgical system in addition to the 10% annual maintenance fee for repair and service. There are also periodic software upgrades that are required to maintain the fluid function of the system. At $200 per use, the instruments also add a significant cost to the individual procedure and to the program as a whole. Furthermore, additional costs include drapes for the actual system, robot specific ports (depend on type of system), and any other accessories necessary for the particular case. There is the
Building a professional sports team requires money, a good head coach, and talented players. The same can be said about starting a robotic surgery program. Once the institution has decided to make the initial investment in a system, the next key step is to find a physician or small group of physicians within the institution who will take charge in building the program: a surgical champion. This individual should not only have the training necessary to operate the robot, but also the support of their respective departments. Often the start of a robotic program is met with resistance because initially the cases may take longer to complete, there may be high rates of conversion from robotic to open surgery, or there may be a lack of support from the operating room staff. Regardless, it is important for the robot program leader to assemble a team that will feel invested in the program and feel that the success of the program depends upon them. The robot team should consist of individuals that are open to change, are willing to learn a whole new instrument, and don't mind enduring the growing pains of implementing a new system. Establishing guidelines Patient selection Several considerations are involved when selecting the route of surgical intervention in patients with gynecologic malignancies. Factors to consider when choosing a robotic surgical approach may include disease type, extent of disease, preoperative imaging, stage, patient age, body mass index, parity, size of lesion(s), and equipment availability. There are currently no published guidelines on patient selection as it relates to robotic surgery in gynecology. In general, our institution has developed some general considerations when determining the use of robotics for patients with uterine or cervical cancer. In the preoperative period, patients receive imaging studies such as CT scans to assess for metastatic disease (as in the case of grade III or atypical uterine cancer), or MRI (to assess for parametrial involvement in the case of cervical cancer with large lesions). The size and weight of the patient often plays a limited role in the decision to proceed with robotic surgery. The main factor is the ability of the patient to tolerate steep Trendelenberg, which is necessary to complete the surgery. Patients with multiple (non-pulmonary) comorbidities need not be excluded from a robotic surgical approach if anesthesia clears them. Table 4 Abbreviated clinical pathway for robotic surgery in gynecologic oncology
Bowel preparation Preoperative Post operative laboratory Post-op diet Analgesia
Ambulation Catheter removal
Endometrial cancer
Cervical cancer
Golytelya Cefoxitin 2gm IV, no anticoagulant Hemoglobin/hematocrit on POD 1 Clear liquid when fully awake, regular diet after 8 h Oral narcotics preferred PRN, no standing order for IV narcotics post PACU Within 4 h When able to ambulate if no bladder trauma
Same Same Same Same Same
Same POD 4–7
a Can substitute magnesium citrate (POD = post operative day, PACU = post anesthesia care unit).
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Protocols, algorithms, clinical pathways Clinical pathways are used to streamline and standardize postoperative care. These pathways are prevalent in the general surgery literature for MIS operations such as appendectomy, cholecystectomy, and increasingly gastric bypass [31–33]. At UNC, our clinical pathway since 2005 allows patients to quickly recover after anesthesia, ambulate, eat, and be discharged from the hospital within 24 h (Table 4). The clinical pathway was duplicated at Florida Hospital with similar success. In both institutions this has led to more efficient utilization of hospital resources without compromising patient care. Patients do not have a standing order for intravenous narcotics once they leave the post anesthesia care unit (PACU). Patients requesting intravenous pain medication are assessed by a physician then given the appropriate medication to provide the appropriate analgesia. We find this is important since excessive and inappropriate pain after minimally invasive surgery may potentially be a sign of an acute abdominal process. Clinical outcomes Since 2005 there has been an increase in the published literature describing outcomes for robotic surgery in gynecologic oncology. Marchal et al.[34] in 2005 first described their experience with hysterectomy, endometrial cancer staging, and radical hysterectomy Piver type II for cervical cancer. They reported only one conversion to laparotomy out of 30 cases; 17% post-operative complication rate, less intra-operative bleeding, less pain, and a shorter hospital stay. Reynolds has since echoed these outcomes as they reported on their initial 7 cases. Post operative results demonstrated excellent lymph node retrieval (average 15 lymph nodes), a blood loss of 50 mL, and a median length of stay of 2 days and no conversions to laparotomy [24]. Sert and Abeler published the results on a series of 15 patients relating to outcomes from robotic assisted radical hysterectomy compared to laparoscopy. In their cohort, the robotic assisted group has less operative times, less bleeding, and a shorter hospital stay compared to traditional laparoscopy [27]. Another paper dealing with outcomes was from Kim et al. where they reported on 10 patients who underwent robotic radical hysterectomy. The average estimated blood loss for the 10 cases was 355 mL and their complication rate was low [8]. Magrina [9] and Fanning [26] have also reported their outcomes with robotic radical hysterectomy. In both studies the median case blood loss was less than 300 mL and the median lymph count was 26 and 18 total pelvic lymph nodes, respectively. In the current largest series by Boggess et al. [6], 51 patients underwent robotic assisted radical hysterectomy with pelvic lymphadenectomy. This cohort of patients had low median blood loss (97 mL), operative time, and a high lymph node count. One of the most distinguishing findings was that the median length of stay was 1 day in robotic cohort compared to 3 days for the comparable open cohort. Staging for endometrial cancer via robotic assistance is also gaining acceptance. Laparoscopic surgical staging has generally led to lower blood loss, less post-operative pain, and shorter length of stay. There has been a single prospective randomized trial assessing the feasibility of laparoscopy for endometrial cancer staging (Gynecologic Oncology Group Lap-2). In this study of over 2000 women, the results showed the procedure was feasible with an average hospital stay of 3 days and a conversion rate of 23% [35]. Since 2005 there have been reports detailing the use of the robot for the staging of endometrial cancer. All reports described shorter operative times, shorter length of stays, and lower estimated blood loss [6,36]. To date, Boggess and colleagues have reported on the largest cohort of patients undergoing robotic endometrial cancer staging (see Table 2). The reported median lymph node retrieval of 33 nodes was also the largest count achieved to date. In their first year's experience, the Florida Hospital group reported a significant reduction in peri-operative morbidity with the
initiation of robotic surgery compared to laparotomy [7]. These studies point the reproducibility and feasibility of the procedure. Summary The development of surgical robots is revolutionizing surgery in gynecologic oncology just as it has done for urology and cardiothoracic surgery. With improvements in operative times, decreased blood loss, and decrease in length of stay after surgery, the robot has allowed surgeons to perform more and more complex procedures, while providing patients the benefits of minimally invasive surgery. Endometrial cancer staging and radical hysterectomy have emerged as the most common gynecologic oncology procedures performed using robotic assistance. Over 1000 systems have been installed worldwide and the use of the robot continues to increase. Community based practices and university based institutions are increasingly adopting the use of the robot and its use continues to expand. In this review, we have outlined templates for the successful initiation of a robotic surgery program in both an academic and private setting, and have discussed many facets of program development and surgeon training. Today, robotic surgery has introduced precision, autonomy, ergonomics and efficiency to minimally invasive surgery. Tomorrow, with development, computers and robots will enhance our abilities beyond what can be achieved or imagined today. It will be our responsibility as surgeons to critically evaluate these new developments in the context of our patients to ensure the best clinical outcomes. Conflict of interest statement Alberto Mendivil, MD has no conflict of interest to declare. Robert W. Holloway, MD is a consultant for Intuitive Surgical. John F. Boggess, MD is a consultant for Intuitive Surgical.
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