New developments Robot-assisted surgery in gynaecology

Transcription

1 The Obstetrician & Gynaecologist /toag ;13: New developments New developments Robot-assisted surgery in gynaecology Authors Matt Hewitt / Michelle O Carroll / Barry O Reilly Key content: The da Vinci robot system has many advantages over straight-stick laparoscopic surgery. The main disadvantage is cost. The da Vinci system has been used in most gynaecological surgical procedures. The system has the advantage of making it easier to use the keyhole approach to tackle more challenging surgical procedures. Learning objectives: To review the current applications of the da Vinci robot in gynaecology. To identify the advantages and limitations of robotic surgery versus laparotomy and conventional laparoscopic surgery. Ethical issues: Is robot-assisted surgery the best choice for women in all gynaecological surgery? In resource-limited environments can the purchase of a robotic system be justified? Keywords cost effectiveness / da Vinci Surgical System / hysterectomy / pelvic organ prolapse / myomectomy Please cite this article as: Hewitt M, O Carroll M, O Reilly B. Robot-assisted surgery in gynaecology. The Obstetrician & Gynaecologist 2011;13: Author details Matt Hewitt MD MRCOG Consultant Obstetrician and Gynaecologist Cork University Maternity Hospital, Cork, Republic of Ireland Matt.Hewitt@hse.ie (corresponding author) Michelle O Carroll Medical Student Cork University Maternity Hospital, Cork, Republic of Ireland Barry O Reilly MD FRCOG FRANZCOG Consultant in Obstetrics/Gynaecology and Subspecialist in Urogynaecology Cork University Maternity Hospital, Cork, Republic of Ireland 183

2 New developments 2011;13: The Obstetrician & Gynaecologist Introduction The advantages of laparoscopic over open surgery are well documented. 1 Although most gynaecological procedures can now be performed laparoscopically, the limitations and technical difficulties of some procedures mean that laparoscopic procedures are not performed universally by all surgeons. Robot-assisted surgery may help to overcome these difficulties. The term robot was first used by the playwright KarelČapek and is derived from the Czech word rabota, meaning serf or labourer. The latest evolution in surgical robots is the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, California, USA). There are three main components of this robotic system: the console (from where the surgeon controls the surgery), the patient cart (to which the operating instruments are attached) and the stack (which holds the processor and diathermy equipment) (Figure 1). The surgeon operates unscrubbed while seated at the console, from which they are able to view the operating field in three dimensions through a stereoscopic viewer. Beneath the viewfinder are the operating arms, which the surgeons move to control the instruments indirectly. At the base of the console are foot pedals, which enable the surgeon to apply monopolar and bipolar diathermy, the clutch pedal, which disengages the instruments, and the camera clutch, which controls the stereo endoscope. The patient cart is a moveable component which is pushed into place after the ports have been placed in the abdomen. The four arms of the cart are then attached to the four trocar ports (one camera port, three instrument ports) and the EndoWrist (Figure 2) instruments are attached to the robot and pushed through the trocars and into the abdomen. There has been a steady increase in the uptake of this surgical system internationally. There are over 1400 units in use worldwide: 20 in the UK, up from eight a year ago, and three in the Republic of Ireland. Advantages of robotic laparoscopic surgery versus conventional laparoscopy The surgeon sees a three-dimensional view of the operating field through a viewfinder, which gives a feeling of immersion without peripheral distraction. The surgeon is able to control the stereo endoscope using the operating arms and foot pedal and is not reliant on an assistant. The stereo endoscope remains motionless unless purposely moved by the surgeon, who is not reliant on a camera operator. The motionless field of view enables increased magnification ( 10) of the surgical field. The fulcrum effect of straight-stick surgery (the hand moves the instrument to the left and the tip moves to the right) is lost in robotic surgery, with the instruments mimicking exactly the movement of the surgeon s hands. Different sensitivity settings on the console enable the surgeon to choose the degree of movement of the instrument tips relative to hand movements depending on the type of surgery being undertaken. The surgeon is seated with arms rested, decreasing surgeon fatigue. Use of the clutch pedal temporarily disengages the arm controls from the instrument tips, enabling the surgeon to return his arms to a more comfortable position should they become hyperextended or flexed during surgery. The da Vinci S system has three operating arms, all of which are controlled by the surgeon, who is able to switch between each instrument using the control pedal. On disengaging one arm to use another, the non-operating arm remains stationary but will still maintain tension on grasped tissue. Figure 1 The main components of the da Vinci Surgical System Intuitive Surgical, Inc. 184

3 The Obstetrician & Gynaecologist 2011;13: New developments The EndoWrist laparoscopic instruments used in the da Vinci system allow seven degrees of movement, thereby mimicking the full range of the surgeon s hand, compared with four degrees of movement with straight-stick surgery (Figure 2). The robot cart holds the surgical trocars so that the fulcrum point is directly on the abdominal wall, decreasing the movement on the abdominal wall and reducing local trauma. The EndoWrist instrument tips and stereo endoscope are disengaged from control if the surgeon s head is removed from the console and they remain stationary. This is advantageous in teaching scenarios where a trainer may wish to demonstrate or assist a trainee during a procedure. The newest version of the da Vinci system, the Si HD, has the potential for using dual consoles where the trainer can operate with the trainee simultaneously. Changing operating instruments can be done at speed, as the newly replaced instrument returns to exactly the same place as the removed instrument and does not need to be tracked into the pelvis with the endoscope. The console concept offers the potential for telesurgery, where the surgeon is an unlimited distance from the patient. Disadvantages of the da Vinci system Cost is the biggest disadvantage. This can be divided into: Initial outlay costs. The yearly service charge (this includes breakdown cover). This is a fixed amount and is unrelated to the number of cases, thus the cost per case decreases as the number of cases performed per year increases. Instrument costs. The EndoWrist instruments are proprietary and each can only be used 10 or 20 times before being replaced. The robot takes time to set up: our experience is an average set-up time of 20 minutes. In our unit this is done while the woman is being anaesthetised, so it does not add significantly to the overall operating theatre time. Docking of the robot does add to overall surgical time; however, as seen in Figure 3, docking time can be reduced to less than 5 minutes with experience. Although the system can be folded away when not in use, it still occupies floor space and it does decrease the room available in the operating Figure 2 The EndoWrist Intuitive Surgical, Inc. Figure 3 Time taken to dock the robot in cases from the Cork University Maternity Hospital 185

4 New developments 2011;13: The Obstetrician & Gynaecologist theatre. The robot does not lend itself to transfer over distance and thus should only be used in one or two adjacent theatres. The system requires training of the theatre staff to set up for operating and a core group of trained nurses needs to be established to keep setup times to a minimum. There is a learning curve associated with acquiring the skills to perform robot-assisted surgery. Surgeons currently require approximately 50 practice cases to perform consistently using the robot. 2 It has been shown that the learning process associated with robotic surgery is quicker than with straight-stick surgery. System breakdown can occur. This is infrequent and can usually be addressed by a reboot of the system. Our experience is that system breakdown has not resulted in conversion to straight laparoscopy or open surgery. The use of the robot could potentially decrease the training of juniors in straight-stick surgery. It is the authors view that training has to adapt to the new technology available and not the reverse. There is a loss of haptic (touch) sensation with robotic surgery, which is preserved in straightstick surgery; forces greater than expected can be transmitted to the instrument tips.this has the potential to cause tissue trauma, although it is the authors experience that this has not caused any complications during surgery. In an emergency the patient cannot be taken out of the Trendelenburg position without undocking, which could potentially delay resuscitation. In practice this would take less than 30 seconds but it highlights the necessity of having experienced staff present in the theatre. The reusable EndoWrist instruments require specialised cleaning which increases initial outlay costs and requires the training of staff. Urogynaecology The risk of a woman undergoing pelvic organ prolapse (POP) or incontinence surgery by the age of 80 years is in the order of 11%. Data from the US National Hospital Discharge Survey 3,4 has shown that > women undergo surgery for POP every year. Other data have shown that the indication for 7 14% of hysterectomies is POP and that the number of surgical corrections for apical prolapse has increased from (1990) to (1999). A recent Cochrane review, 5 along with guidelines from the International Consultation on Incontinence, 6 suggests that there is currently little evidence for the routine use of prosthetics in transvaginal POP surgery and that any theoretical advantage must be balanced against the potential morbidity and cost. This Cochrane review also suggested that the abdominal sacrocolpopexy (ASC) procedure was the superior procedure to treat vault prolapse compared with sacrospinous fixation. The potential drawbacks of the ASC include longer operating time, length of stay and recovery compared with vaginal surgery. These problems have been overcome, however, by the introduction of the laparoscopic approach. 7 The introduction of vaginal mesh kits for apical prolapse has led to mass usage without good comparative studies. Maher et al. 8 presented data from a prospective randomised controlled trial comparing total vaginal mesh repair and laparoscopic ASC and demonstrated superior outcomes with laparoscopic ASC at 2 years. This study was performed by an expert laparoscopist, however, and the laparoscopic approach is not widely performed ( 5% of ASC procedures are performed using laparoscopy). The procedure typically requires difficult dissection and extensive suturing which is facilitated by the da Vinci system, enabling an intuitive endoscopic approach for the general gynaecologist. Akl et al. 9 looked at the learning curve for robotic ASC, demonstrating a reduction in operating time by 25% after the first 10 cases, concluding that robotic ASC is feasible, with acceptable complication rates and a short learning curve. Hysterectomy The benefits to women of laparoscopic hysterectomy compared with open surgery are well documented. 1 Even with an increasing trend toward the laparoscopic approach, laparotomy is still the most common surgical modality. 11 In the UK and the Republic of Ireland, consultants perform 60% of hysterectomies abdominally, 37% vaginally and 4% using laparoscopic assistance. 12 The low acceptance rate of laparoscopy may be based on the learning curve threshold. Using robotic assistance may be a way to facilitate the adoption of minimally invasive surgery by more surgeons, as with robotic assistance novices perform comparably to experienced laparoscopic surgeons. 11,13 Hence, surgeons inexperienced in conventional laparoscopic procedures can perform more surgical procedures laparoscopically using the robot. Another clear advantage of robotic surgery is that fewer errors are made than with straight-stick surgery. This was demonstrated in a recent retrospective review of hysterectomies 14 completed before and after the initiation of a robotics programme. The perioperative outcomes of 100 women undergoing total laparoscopic hysterectomy versus 100 robotic hysterectomies were analysed. Compared with straight-stick surgery, with robot surgery there was less blood loss (mean 61.1 ml versus 113 ml), reduced hospital stay (1.1 versus 1.6 days) and the last 25 robot-assisted hysterectomy cases were 13.7 minutes shorter than the non-robotic cases. Additionally, the number of 186

5 The Obstetrician & Gynaecologist 2011;13: New developments exploratory laparotomies and intraoperative conversions to total abdominal hysterectomy from laparoscopy in the laparoscopic cohort was significantly greater than in the robotic group. Oncology surgery Boggess et al. 15 compared full surgical staging for endometrial cancer, including pelvic lymphadenectomy and para-aortic lymphadenectomy. In comparable groups the robot-assisted cohort had a shorter hospital stay than open surgery but a similar stay compared with laparoscopic surgery (1 versus 1.2 days). The estimated blood loss was significantly lower in the robot group compared with both the open and laparoscopic group. Robot surgical time was increased compared with open surgery but significantly less than with straight-stick laparoscopy. Lymph node yields were greater in the robot group and there were fewer major surgical complications in the robot group compared with both groups. They argue that use of the robot has increased the number of women in whom full staging for endometrial cancer can be achieved. Persson et al. 16 described the feasibility of radical hysterectomy using the robot in 80 women. There were minimal complications, which decreased in frequency as the surgeons became more experienced. Complications were minor and included two port site hernias and two cases of vaginal vault dehiscence. Skin-to-skin operating time (including robot docking) fell to an average of 2 3 hours after 20 cases but the first few cases did take up to 6 8 hours. Myomectomy Laparoscopic versus laparotomy management of leiomyomata is associated with decreased postoperative morbidity and faster recovery times. 17 Endoscopic management of leiomyomata can be challenging, however, with difficulty relating to the size of the fibroids, enucleation and subsequent repair of the defect in the uterine wall and blood loss which may relate to high conversion rates to laparotomy. The advantages of the robot over straight-stick surgery help to overcome some of these technical difficulties. A recent study 18 demonstrated decreased blood loss, decreased complication rates and reduced hospital stay but increased overall costs compared with open surgery. Other uses The da Vinci system is also useful in the surgical management of extensive endometriosis: because of the advantages previously described it lends itself to the type of fine dissection/resection required in pelvic disease. Tubal reanastomosis in infertility is another application that benefits from the fine detail of robotic surgery and this is practised in many centres around the world, although research data comparing the benefits against assisted conception techniques are limited. Finally, there have been a few case reports of abdominal interval cervical cerclage performed robotically but, again, the data is limited. Conclusions The advantages of the robot system are numerous and are beneficial to both the patient and surgeon. There is, however, a dearth of randomised studies directly comparing straight-stick and robotic surgery. An example of such a trial, however, is the planned randomised phase III study proposed to compare laparoscopic radical hysterectomy with robotic radical hysterectomy. 19 Undertaking such a study will always be difficult, as surgeons with access to a robot will find it difficult to justify operating straight-stick, firstly because they are more proficient in robotic surgery compared with straight-stick surgery and, furthermore, because they believe it to be unethical to operate on patients using the straight-stick method, which they believe to be inferior to robotic surgery. The main disadvantage of the da Vinci system is cost. There is no alternative similar system available on the market and, until there is, costs are unlikely to decrease. In a privately funded medical system patients will insist on the most advanced technology available and this has driven sales in the USA. In publicly funded institutions justification of the cost of new technology is more difficult and different specialties need to come together to share these costs. Since its introduction the da Vinci surgical system has been updated three times and this only represents the start of what is still an emerging technology. New advances are being introduced; for example, single-port access. In the Cork University Maternity Hospital it is our goal that no woman should undergo open surgery that cannot be safely undertaken by minimal access surgery. The purchase of the da Vinci system has made this goal now more readily achievable by enabling experienced laparoscopic surgeons to perform more complex procedures in even in the most challenging of patients and has enabled surgeons with less laparoscopic experience to undertake simpler procedures safely. Declaration of interests Matt Hewitt has been the recipient of travel bursaries for attendance at robotic conferences. References 1 Desimone CP, Ueland FR. Gynecologic laparoscopy. Surg Clin North Am 2008;88:319 41, vi. doi: /j.suc Lenihan JP, Jr., Kovanda C, Seshadri-Kreaden U. What is the learning curve for robotic assisted gynecologic surgery? J Minim Invasive Gynecol 2008;15: doi: /j.jmig

6 New developments 2011;13: The Obstetrician & Gynaecologist 3 Graves EJ. National hospital discharge survey. Vital Health Stat ;112: Popovic JR National Hospital Discharge Survey: annual summary with detailed diagnosis and procedure data. Vital Health Stat :151;i v, Maher C, Feiner B, Baessler K, Adams EJ, Hagen S, Glazener CM. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev 2010;14(4):CD Freeman RM, Cosson M, Davila GW, DeprestJ, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) jointterminology and classification ofthe complications related directly to the insertion ofprostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery. Neurol Urodyn 2011;30:2 12. doi.org/ /nau North CE, Ali-Ross NS, Smith AR, Reid FM. A prospective study of laparoscopic sacrocolpopexy for the management of pelvic organ prolapse. BJOG 2009;116: doi: /j x 8 Maher CF, Feiner B, DeCuyper EM, Nichlos CJ, Hickey KV, O'Rourke P. Laparoscopic sacral colpopexy versus TVM for vault prolapse: a RCT. Am J Obstet Gynecol 2011;204:360e Akl MN, Long JB, Giles DL, Cornella JL, Pettit PD, Chen AH, et al. Roboticassisted sacrocolpopexy: technique and learning curve. Surg Endosc 2009;23: doi: /s El-Hemaidi I, Gharaibeh A, Shehata H. Menorrhagia and bleeding disorders. CurrOpin Obstet Gynecol 2007;19: doi: /gco.0b013e3282f1ddbe 11 Reynolds RK, Advincula AP. Robot-assisted laparoscopic hysterectomy: technique and initial experience. Am J Surg 2006;191: doi: /j.amjsurg Kay VJ, Das N, Mahmood TA, Smith A. Current practice of hysterectomy and oophorectomy in the United Kingdom and Republic of Ireland. J Obstet Gynaecol 2002;22: doi: / Heemskerk J, van GemertWG, de Vries J, Greve J, Bouvy ND. Learning curves of robot-assisted laparoscopic surgery compared with conventional laparoscopic surgery AND an experimental study evaluating skill acquisition of robot-assisted laparoscopic tasks compared with conventional laparoscopic tasks in inexperienced users. Surg Laparosc Endosc Percutan Tech 2007;17: doi: /sle.0b013e31805b 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;15: doi: /j.jmig 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;199:360 e Persson J, Reynisson P, Borgfeldt C, Kannisto P, Lindahl B, BossmarT. Robot assisted laparoscopic radical hysterectomy and pelvic lymphadenectomy with short and long term morbidity data. Gynecol Oncol 2009;113: doi: /j.ygyno Seracchioli R, Rossi S, Govoni F, Rossi E, Venturoli S, Bulletti C, et al. Fertility and obstetric outcome after laparoscopic myomectomy of large myomata: a randomized comparison with abdominal myomectomy. Hum Reprod 2000;15: doi: /humrep/ Advincula AP, Xu X, Goudeau St, Ransom SB. Robot-assisted laparoscopic myomectomy versus abdominal myomectomy: a comparison of short-term surgical outcomes and immediate costs. J Minim Invasive Gynecol 2007;14: doi: /j.jmig Obermair A, Gebski V, FrumovitzM, Soliman PT, Schmeler KM, Levenback C, et al. A phase III randomized clinical trial comparing laparoscopic or robotic radical hysterectomy with abdominal radical hysterectomy in patients with early stage cervical cancer. J Minim Invasive Gynecol 2008;15: doi: /j.jmig