Abstract
Abstract
Background:
Since the late 1980s, minimally invasive surgery (MIS) has been one of the fastest growing approaches for surgical procedures. However, its development has reached a plateau. One of the reasons is the difficulty to operate on more complex cases, such as neonatal procedures. Some experts report outstanding outcomes for complex operations, but not all surgeons may be able to achieve the same results. Is robotic surgery (RS) a solution?
Methods:
To answer this question, we reviewed the current indications of RS for the pediatric population and the steps needed to incorporate the robotic surgical system in a children's hospital. We reported our experience and presented our first results and the encountered problems.
Results:
After a year and a half of experience with RS, several lessons were learned: (1) the current robotic surgical system cannot yet be considered a replacement to conventional MIS, (2) docking is less time consuming than expected, (3) postoperative pain is significantly decreased, (4) the absence of haptic feedback is still a matter of concern, and (5) costs can be afforded by sharing the RS with adult surgeons.
Conclusions:
Based on our experience, the advantages seem to outweigh the drawbacks as it encourages team building and increases overall comfort for the surgeon. However, the current literature fails to prove that RS gives better results for pediatric patients. New advances in technology will probably help to overcome the encountered difficulties and the high costs.
Introduction
S
In pediatric surgery however, there is no such evidence of superiority over the open approach 1 and MIS can only be considered feasible and safe in children when performed by experienced surgeons. 2 The limitations of conventional MIS become more apparent when applied to the little patient. In particular the decrease in dexterity, the limited degrees of freedom, two-dimensional view, and the lack of depth perception make MIS challenging in the pediatric population. These limitations can be overcome with training and experience but some operations are still difficult to perform, even for highly skilled surgeons.
To understand where we stand today in terms of indications for conventional MIS surgery, a few considerations have to be made as follows: (1) the majority of general pediatric surgery cases may be accomplished with a minimally invasive approach (i.e., appendicitis, cholecystectomy, and gastroesophageal reflux); (2) more complex operations, such as lung lobectomy, nephrectomy, or pyeloplasty, can be successfully performed. However, extensive training is required which is why they are mainly reserved to experts in the field; (3) some operations are extremely challenging even for highly skilled MIS surgeons; this is particularly the case for oncologic and neonatal surgery because of the narrow operative spaces and the low caseload; and (4) many of the instruments used in pediatric MIS are identical to those used for adult patients, and are clearly too big to be functional on children. In addition, the combination of financial constraints and low demand makes it difficult to encourage the surgical industry to develop smaller tools for our field. 3 Our team feels that after 20 years of exciting progress in pediatric MIS, a plateau has been reached because of the reasons listed previously. Could robotic surgery (RS) be a solution?
To date RS has been largely adopted, especially for urological, gynecologic, and colorectal procedures. However, evidence-based studies showing better results compared with laparoscopy and open surgery are still limited.4,5 At present, the most performed robotic procedure is prostatectomy. Although it showed similar outcomes as compared with open retropubic prostatectomy, 6 randomized controlled studies and meta-analysis in gynecologic and colorectal surgery favored RS. This was because of better outcomes in terms of operative time, conversion rate, and LOS.4,5,7 Unfortunately, the application of RS in pediatric surgery is still controversial. With this review, we aim to evaluate how the RS technology can impact a pediatric hospital and report our experience with the implementation of a robotic surgical program.
Implementation of a Robotic Program at
Hopital Universitaire des Enfants Reine Fabiola
(Huderf)
In 2012, the growing perception that the refinement of pediatric MIS was reaching a plateau led us to believe that the robotic system would have been the next step in surgical development. The rationales that compelled us to implement a Da Vinci Si Robotic System in our hospital were the following:
We were looking for a new technology that could have taken over conventional MIS, overcoming its limits, especially for technically challenging procedures. We felt that RS would have been the next step in surgical development, helping surgeons to improve their skills and to increase the quality of MIS surgery. We felt that RS would have been an incentive for the administration of our hospital, a third-level pediatric center, to invest more in minimally invasive technologies. To ensure the best results for a surgical workforce, team building is of paramount importance. The team is urged to work more efficiently in an effort to deliver the desired results. Team building in the operating room (OR) helps to foster better and open communication among the team. We believed that RS, more than any other type of approach, would have hugely contributed to team building in our surgical department. The robot signals technological advancement and innovation. Other than being a marketing product to increase attractivity outside the hospital, it increases morale among the people working inside the institution. Ultimately, single incision surgery is something that we have always wanted to attempt but, with very few exceptions, it was impossible to achieve with conventional MIS as the instruments were specifically developed for adult patients.
8
Huderf Business Plan
Once the administration of our institution approved the proposal to purchase the Da Vinci robotic system, we finally obtained the implementation of a Da Vinci Si model in August 2015. The initial investment was entirely supported by our children's hospital. Throughout the years, we cut down on costs through grants and fundraisings.
At our institution, the children's hospital owns the robot. To help cover the costs the adult surgeons are allowed to perform robotic procedures in the pediatric OR, however, the pediatric surgeons maintain control over its scheduling and use. This is a different scenario compared with many other hospitals around the globe. There are three main advantages for our arrangement: (1) the centralization of the robotic system facilitates more efficient scheduling for robotic cases, (2) incentivizes pediatric surgeons to adopt RS more frequently and to perform more challenging procedures, and (3) sharing the robot with adult surgeons is still feasible and helps to cut down on expenses. The annual costs are partly compensated by a 1500 € fee paid by the adult hospital for each adult patient operated with the robot. Besides, as adult surgeons use 8 mm instruments and pediatric surgeons 5 mm instruments each hospital is responsible for purchasing their own tools. Ultimately, our business coordinators simulated a plan to cover the overall expenses and calculated a minimum number of patients to be operated over a 5-year period that reached a plateau of 120–150 pediatric operations per year: first year, 30 cases; second year, 60 cases; third year, 100 cases; fourth year, 120 cases; fifth year, 120–150 cases.
Preliminary Results
During the first year, we almost achieved our business goal by operating on 24 children in 10 months. The global number of pediatric patients who underwent robotic procedures during the first 2 years is summarized in Table 1. Extra costs owing to the “built-in obsolescence” of robotic instruments were also recorded (Table 2).
MIS, minimally invasive surgery.
Overall, we encountered four complications. The first one was an iliac artery spasm after a bilateral Lich–Gregoir procedure. Most probably, the spasm was because of the patient's positioning—this complication has been extensively documented during an open approach. However, iliac artery spasm can also be the result of compression of the artery by 5 mm instruments when the trocar is too close to the groin. The patient recovered uneventfully a few hours later and received a subcutaneous anticoagulation prophylaxis. A second complication was a ureteral necrosis after robotic excision of a rhabdomyosarcoma of the groin that was infiltrating the ureter. With the robot the tumor was easily dissected, but part of the infiltrated ureter became necrotic. This is a complication that has been documented with both conventional MIS and open approach. Unfortunately, because of the extent of the necrosis, we were not able to repair the ureter robotically. An open ureteral reimplantation with psoas bladder hitch was necessary. A third complication occurred during a pyeloplasty. We had to convert to an open approach because the pelvis was completely hidden into the kidney making presentation even impossible after “conversion” to a laparoscopic approach. The last but most important complication was a bile duct injury during a cholecystectomy. The patient had an anatomic variation of the cystic duct that had a parallel course with the common hepatic duct. The bile duct was immediately repaired robotically and stented. The patient was discharged 12 days later. After an extensive discussion of this case at our morbidity and mortality multidisciplinary meeting, we concluded that the wrong orientation of the camera that was rotated upside down during the dissection contributed to the adverse event.
This complication had a negative impact on our robotic program that was suspended for few months. We finally restarted the program in April 2017.
Discussion
Many criticisms were raised more than 20 years ago when MIS was introduced in pediatric surgery, including difficult tissue manipulation in narrow spaces, discrepancy between the size of the child and that of available instruments, and higher costs compared with traditional open surgery. Nowadays, RS is experiencing the same hurdles and skepticisms. Although many studies regarding economic aspects related to the use of RS in the adult population have been reported, this issue has not yet been adequately examined in pediatric patients. At present, although it is difficult to define both applicability and reproducibility of RS in children, most surgeons proved to appreciate the change from classic open laparotomy/thoracotomy to RS, and the possibility to overcome some major limits of laparoscopy.9–11 In addition, it has also been proved how easy it is to shift from laparoscopy to RS. 12 Certain anatomic structures such as the deep pelvis can be technically demanding when approached with conventional laparoscopy because of the very narrow working spaces. This is the case of restorative proctectomy with J-pouch ileorectal anastomosis or esophagogastric disconnection. RS seemingly offers advantages over traditional MIS, such as three-dimensional (3D) vision, greater magnification, operator-controlled camera movement, improved dexterity, motion scaling, tremor filtration, and removal of the fulcrum effect, allowing for better and more precise dissections. Similarly, rectal dissection can be easily carried down to the levator ani with minimal traumatism of perirectal structures with RS. Furthermore, RS proved to be particularly suitable for oncologic surgery, given the reduced need for mobilization and manipulation of tissues together with a sharper dissection permitted by the increased degrees of freedom of robotic arms.
The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Technology and Value Assessment Committee have compared RAS with conventional MIS in the adult population in different surgical areas (foregut, colorectal, hepatobiliary, and pancreatic surgery), analyzing safety, efficacy, and costs. Although the authors found RS to be as safe and effective as conventional MIS, they underlined that the increased costs must be taken into maximal consideration when resorting to such approaches. In addition, another downside of RS is linked to the Intuitive Surgical, Inc. monopoly. Using a clever business model, Intuitive bought out all of its telesurgery competitors and closed the market to other companies. The consequence is a lack of competition with incredibly high selling prices. The “built-in obsolescence” of each instrument is the paradigm of this business model. According to the Intuitive 2015 annual report, “a programmed memory chip inside each instrument is designed to prevent the instrument from being used for more than the prescribed number of procedures to help ensure that its performance meets specifications during each procedure.” On the contrary, Intuitive Surgical, Inc. brought some criticism to the SAGES assessment in terms of modality of comparison between robotic and laparoscopic surgery, adoption of exclusion criteria for analyzed studies, and modality of cost comparison. Of note, one of the key points raised was that RS should be compared with open surgery rather than conventional MIS, given the wider number of procedures that are amenable with the RS approach. 13 We agree on that and we suggest that in certain instances RS should represent the true alternative to open surgery. This is one of the most intriguing take-home messages that underline how RS allows surgeons to apply MIS concepts to surgical procedures that are usually performed through laparotomy/thoracotomy.
Our preliminary experience turned out to be extremely positive, confirming that the involved staff members are very keen in investing in high-level technology that extended the horizon of the applicability of MIS. The Da Vinci Robotic System is a tool that offers an MIS approach to many pediatric pathologies, in particular, those who require complex reconstructive surgery. Although cost-effectiveness is still a matter of debate, a number of pediatric patients would surely benefit from this highly innovative approach. Even simple operations can be used as a “gateway” procedure to RS with the intent to progress to more complex procedures. Gastroesophageal reflux surgery is a good example. Although the robot will never prove its superiority over conventional MIS, a recent status evaluation by Chaussy et al. confirms that fundoplication is one of the most performed procedures with robotic assistance in children. 14 In addition, because of its versatility, an increasing number of RE-DO surgeries are being performed with the robot. 15
Overall, we have learned a few valuable lessons from our experience:
The prohibitive cost of the robot is probably the most important reason why pediatric surgeons have not embraced this technology as readily as their adult colleagues. A recent analysis by Mahida et al. compared hospitalization costs of robotic, laparoscopic, and open procedures. Not surprisingly, the authors demonstrated that general costs of RS were higher than nonrobotic operations.
16
We are cognizant of the higher costs and we have estimated that for each operation the added cost range between 800 € and 1200 €. Most of this extra cost is because of the “build-in obsolescence” of the instruments. However, cost sharing with our adult colleagues has enabled us to adopt this technology. The need for accessory MIS instruments is seldom reported in articles comparing costs between MIS and RS. However, robotic procedures in children are oftentimes impossible to be performed without the aid of an additional trocar—to retract, aspirate, irrigate, or clip tissues. Patient's size does not appear to affect surgical success. A comparative study by Ballouhey et al. reported same outcomes in children weighing < and >15 kg.
17
However, proper port placement is critical when using the 5 mm instruments. They need a wider workspace because of their lower endowrist dexterity as compared with the 8 mm instruments.
18
Team training was faster than expected. Docking was learned quickly by the nurses, largely because of preoperative drawing of patient's positioning—docking time was roughly 30 minutes after the initial five procedures. We performed a total colectomy for Hirschsprung's disease, repositioning the robot three times during the operation (left side, right side, and pelvic positions), in <170 minutes. Pediatric surgical caseload is low. Therefore, “gateway” procedures such as Palomo for varicocele are critical to improve the learning process and to attempt more challenging operations. The preliminary results of an ongoing study showed that in case of proper docking and port positioning there was minimal postoperative pain. This is leading us to push the envelope and to attempt single site surgery in the near future. Working without haptic feedback is a new experience for a traditionally trained surgeon. However, despite the lack of tactile sensation, the markedly enhanced 3D view and instrument dexterity offer significant advantages for complex pediatric procedures.
What should we expect in the future for pediatric RS?
Development of smaller instruments with higher degrees of freedom.
Development of new and cheaper robotic surgical systems, as many patents are about to expire leading to a market expansion.
Application of haptic technology to the new robotic systems.
Accredited training programs and certifications in robotic pediatric surgery.
When all the expectations listed above are fulfilled, RS will most likely take over conventional pediatric MIS and allow for more complex procedures, such as neonatal, 3 cancer, 19 and fetal surgeries. 20 Furthermore, new promising technologies such as virtual and augmented reality, 3D reconstruction and printing, and intra-abdominal mini-robots will soon be at our fingertips.21,22 It is our responsibility to stay tuned as we witness ongoing developments in this fascinating technology-driven field of research.
Conclusion
Obviously, implementing a robotic program in a children's hospital is not an easy game. This is mainly because of the fact that the advantages of the current robotic system are still debatable. Based on our experience, the benefits seem to outweigh the drawbacks in terms of team building, attractivity, and comfort for the surgeon. However, the current literature fails to prove that RS gives better results for pediatric patients. New advances in technology will probably help to overcome the encountered difficulties and the high costs.
Footnotes
Disclosure Statement
No competing financial interests exist.
