Robotic surgery is ready for prime time in India: Against the motion.

The use of Robotic Surgery as a purported adjunct and aid to Minimal Access Surgery (MAS) is growing in several areas. The acknowledged advantages as also the obvious and hidden disadvantages of Robotic Surgery are highlighted. Survey of literature shows that while Robotic Surgery is "feasible" and the results are "comparable" there is no convincing evidence that it is any better than MAS or even open surgery in most areas. To move "Robotic Surgery is ready for prime time in India" with no less than two dozen robots, many sub-optimally utilized for a population of 1.2 billion seems untenable.

INTRODUCTION

Over more than 50 years I have done some open surgery and some laparoscopic surgery. I have never done robotic surgery. I have seen it only twice. The first time was in a dedicated Cardiac hospital in a Metro city where, in the robotic operating room (OR), one case was done meticulously and laboriously. This was the only case in that OR that day, while in each of the other ORs in the complex four cases were done. I was not impressed. The second time, I saw that robotic surgery was at a hospital dedicated to Urology in a small town, Nadiad. I was more than impressed. I was awed and inspired. I can think of no better authority to move the subject for this debate than Dr. Mahesh Desai, a remarkable visionary.

That I stand against the motion should not be misconstrued that I am antichange, reluctant to accept advance and new technology. For 50 exciting years I have seen, and been part of, the changing face of surgery and am convinced that in surgery the only truth is change. It is with this background that I evaluate the role of robotic surgery pragmatically vis a vis laparoscopic as also open surgery as practiced in India, to establish that there is no logical or rational way in which this motion, as it is worded: Robotic surgery is ready for prime time in India, can be approved.

When laparoscopic cholecystectomy burst was on the surgical scene over 25 years back it was strongly resisted, disparaged and even ridiculed by academic surgery and the leading surgical centers of excellence. It was however enthusiastically accepted by the true surgical community, ensuring it became the ‘gold standards’ within 2 years, sweeping aside the resistance of the centers of excellence. Robotic surgery has in contrast been advocated and eulogized for several years by some centers of excellence. However, it has not been adopted by the general surgical community over all these years as in spite of its humongous cost there are no confirmed, irrefutable outcome benefits. There are innumerable areas of controversy with relation to the advantages, disadvantages, results, complications, and outcome of robotic surgery. However, there are two aspects of robotic surgery over which there is absolutely no controversy.

Robotic surgery is excellent for the surgeons’ comfort, seated at an ergonomically designed console with easy and gentle hand and foot manipulation, perfect vision, and almost no physical strain, removed from the high tension atmosphere of the operation table.

The fact that Intuitive Surgical Inc. the manufacturers of the da Vinci Surgical System had a turnover, 2 years back, of well over $ two billion, and rapidly rising.

While appreciating the benefits of robotic surgery to the surgeon and to industry, I submit that the sole consideration of surgery hitherto has been the benefit of surgery, in all disease processes, to all patients, and in all places. It is with the patient as the sole end point that I discuss the motion.

CURRENT STATUS OF ROBOTIC SURGERY

Robotic surgery certainly has specific advantages in the performance of surgery: Magnified view with three-dimensional vision, ergonomic hand movements with full range of movements, removal of the fulcrum effect of laparoscopy, scaling down of hand movements facilitating delicate maneuvers, and minimization of hand tremors. With these advantages so strongly stressed by the robotic enthusiasts, it may appear that all laparoscopic surgery be done with robotic assistance. The reason this is a far cry from reality is the disadvantages heavily outweigh the advantages.

The larger OR space required by the humongous footprint of the robot, longer total OR time, difficulty in changing the operation table position after docking, feasibility of the surgery (by and large) only in one quadrant of the abdomen are some of the disadvantages. More important is the total lack of tactile feedback, compromising surgery, and safety. Sustrata had stressed the importance of tactile feed back to the surgeon ‘the surgeon's hand is the most important instrument’[1] and Freyerin his paper on prostatectomy wrote ‘the surgeon must have his eye at the tip of his finger’. In the laparoscopic era, the eye is transferred to the tip of the laparoscopic instrument [Figures 1 and 2].

Figure 1

From the dawn of surgery the power of touch has been the surgeon's most vital attribute

Figure 2

In MAS the surgeons’ finger tips are transferred to the ends of the hand instruments for tactile feedback - an attribute lacking on Robotic Surgery

To the surgeon, loss of touch is a heavy price to pay for the gain in technology. There is growing evidence that the complications of robotic surgery are under reported, as is the incidence of irrevocable operative malfunctioning during the procedure.[2] Conversion to laparoscopic or open surgery in case of difficulty is laborious and time consuming and could be life-threatening in a dire emergency. With an initial investment of $1,500,000 to $2,000,000, annual maintenance cost of $350,00 to $400,00, expensive disposable instruments and sterile drapes, longer OR time, the cost of robotic surgery is tremendously greater than the cost of laparoscopic or open surgery. Affordable, articulating hand instruments and the latest affordable three-dimensional equipment for laparoscopy give cost-effective laparoscopy two important benefits of the robot.

To my mind the most significant and logical deterrent to the unbridled acceptance of robotic-assisted surgery is the total lack of conclusive data, as currently available, to substantiate an outcome improvement over laparoscopic surgery or even open surgery to honestly justify the substantially increased cost, least of all in developing countries.

This is not to deny specific advantages of the robotic system. Its optimal and ultimate application will focus on specific procedures, performed in one quadrant, in a cramped space like the pelvis, requiring precise maneuvers and suturing, ideally on fixed tissue. The classical example which fits the bill could be cancer prostate, even cancer cervix. The main thrusts for the robot are:

The strong and ingenious campaign of the manufacturers.

Hospitals view the robot as a good business investment to generate bigger patient load.

The surgeon with little knowledge and no experience of robotic surgery who would like to jump on the band wagon, In Fear of Missing Out, the ‘IFMO’ epidemic now seen in surgery. All these will increase the sale of the robot, not necessarily improve robotic surgery. The true thrust for robotic surgery will come from the dedicated, passionate, committed robotic surgeons who, over time, will establish better outcome in their niche areas of surgery.

Cancer of the prostate is the best indication for robotic surgery. Cancer of the prostate is by far one of the commonest male malignancies, usually located to the prostate where radical prostatectomy is the only definitive mode of treatment.[3] Open radical prostatectomy (ORP), first done by Hugh Young in 1905 was the established gold treatment for almost a century and in view of its relative ease of performance, reproducibility, learning curve, oncologic outcome, quality of life after surgery, and cost efficiency in all economic strata, still remains the gold standard to several pragmatic workers. Laparoscopy entered the field of urology early and laparoscopic radical prostatectomy (LRP) has a track record of over 20 years. Though the outcomes matched those of ORP with the added benefit of shorter hospital stay and reduced blood loss, LRP required the ultimate laparoscopic skills, which become a limiting factor. In 2000, the first robotic-assisted laparoscopic radical prostatectomy (RALRP) was performed with greater ease than the LRP, thanks to the advantages of the robotic system, giving a strong impetus to this procedure.[4] Regardless of these advances, there is minimal consensus regarding the optimal treatment of prostate cancer.[5]

OUTCOME COMPARISON

The most important aim of treatment of prostate cancer is cancer cure/control, as an outcome evaluated by negative margins of resection and PSA levels in long-term follow up. Margin status is an accepted predictor of recurrence. OPR and RALRP have a similar negative rate[67] while LRP has a slightly higher margin rate.[8] Five-year freedom from PSA failure rates is variously reported as almost 80% for ORP, 78% for LRP, and 84-90% for RALRP.[9] Radical prostatectomy has the benefit of several long-term (over 15 years) follow up. Intraoperative and postoperative complications are similar in the three groups. Blood loss is markedly reduced in both the laparoscopic methods. This is not related to the technical superiority of these two methods but because the pneumoperitoneum required for minimal access surgery (MAS) reduces the pressure gradient with less venous and capillary oozing.[10] While MAS methods decreased length of hospital stay by one day, the reported length of stay in various series varies considerably.[11] Because ORP is done through a very low abdominal, relatively small incision (6-8 cm) the pain scores for ORP are relatively low, considering RALRP has a cumulative incision of 4-5 cm in the upper abdomen.

Quality of Life Outcomes

RALRP has marginally better continence outcome then LRP and comparable outcomes to ORP.[712] Potency data do not support the superiority of any one technique. Surprisingly, a study between RALRP and ORP, after evaluation of several variables, showed patients after RALRP were 3-4 times more dissatisfied and regretful than after ORP, perhaps due to heightened expectations from the latest and costliest method![13]

While viewing results of various methods one tends to forget the importance of the element of bias in each study. There are also surgeon-generated imponderables in assessing results and outcome of parallel procedures — the surgeons experience, the volume of work generated, and the surgeon-to-surgeon variation in individual technique, talent, and capability.[14] Stressing the importance of the qualities of the surgeon ‘the difference between Tiger Woods and the local club champion is not the putter, the irons or the woods, it is in skill’.[15]

In a similar manner review of meta-analysis of open, laparoscopic, and robotic surgery for cervix cancer show no substantial outcome differences apart from shorter hospital stay and reduced blood loss in the MAS procedures.[16] The same holds for colon cancer, where the Robot has no proven patent-specific advantage, and is far more costly[17] and the evidence is weak.[18]

HEALTH CARE IN INDIA

‘Of all forms of inequality, indiscrimination and injustice in healthcare is the most shocking and inhumane’. Martin Luther King Junior.

Indian healthcare is the ultimate model of a schizophrenic health-care system. We take great pride, with good reason, in our state-of-the-art hospitals and tertiary health-care centers which could compare with the best in the World. Our surgery has pushed the edge of the envelope to the ultimate, be it in transplant surgery, specialty-wise surgery, minimal access surgery, NOTES, robotic surgery as also in supportive areas as interventional, and diagnostic advances. But in Indian health care, what is reality to some is an unbelievable mirage to the vast majority. Sadly for the majority, there is just no health care — no toilets, sanitation, potable water, immunization, and functional primary health care center. With planned health spending not growing over a measly 1% of the gross domestic product (GDP) for decades, meager health support, no insurance cover, out of pocket healthcare spending is the norm for almost 80% of the population. Out of pocket spending for healthcare is not taken into account in determining the ‘poverty line’, else the percentage below the poverty line would be much greater. Poverty enforces malnutrition and breeds ill-health.[19]

We the surgeons who practice the newest advances of surgery, with studied indifference turn our backs to the health-care scenario as it affects the majority of Indians, where, particularly in tribal areas, a strangulated hernia may not be seen by a qualified doctor, leave alone a surgeon.

CONCLUSION

Robotic surgery is made out by the manufacturer and a few surgeons to be a ‘different’, ‘new’, ‘unique’ surgery. Fundamentally robotic surgery is laparoscopic surgery. The robot by placing a computerized interphase between the surgeon and the patient gives specific advantages to the laparoscopic surgeon in the performance of the procedure. Just as the CT scan is a computer with eyes, the robot is a computer with arms; its functionality is totally surgeon dependent. A robot, at best, will enable a mediocre laparoscopic surgeon to be a better laparoscopic surgeon, a robot does not perform surgery, it may, at best, in part compensate for surgeon deficiencies.

There are over 5000 peer-reviewed papers published on robotic-assisted laparoscopy. All of them deliver the same message. Robotic-assisted surgery is ‘feasible’ and the outcome is ‘comparable’ and ‘similar’ to laparoscopic, even open surgery. Laparoscopic cholecystectomy, for over 25 years has been practiced safely, quickly, and economically all over India from tertiary centers to small remote towns, even villages. Robotic-assisted surgery has been advocated for cholecystectomy. Does it make sense to downgrade a routinely practiced procedure by making it far more costly, cumbersome, time consuming just because it is ‘feasible’? Surgeons have the maturity to decide what ‘can’ be done is different from what ‘should’ be done. It has been said by a thinking laparoscopic surgeon ‘Once you have a hammer, everything looks like a nail’. Having a new toy does not justify our hammering or nailing all our patients.

One of the major success story in the upliftment of surgery in small towns of India is the amazing, gratifying spread of laparoscopic surgery through the length and breadth of India, with the passion, ingenuity and indomitable spirit of the small town, rural Indian surgeon, practiced in the face of all difficulties with safety, innovation, and economy. To be of practical benefit in a developing country, new technology must adhere to the concept of the5As: Affordable, acceptable, accessible, available and appropriate.[20]

Where does robotic surgery with the down payment of two million US dollars, annual maintenance of $350,000, expensive disposable equipment, in return for safety and outcome ‘comparable’ or ‘similar’ to affordable laparoscopic in almost all procedures and to open surgery in several, hope to enter the equation? In India?

The concept of ‘prime time’ is yet another media hype to denote viewer time when the maximum numbers of people are free and available to view the program. In surgical terms, hence, ‘prime time’ would denote the maximum surgical good to the maximum number of patients. Can any Indian surgeon, in any honesty, accept that two-dozen Robots, serving a population of one and a quarter billion, catering almost exclusively to the upper crust, could ever come in the ambit of surgical prime time in India?

Epilogue

There is, and always will be, a growing importance for the development of better robotic surgery in specific disease procedures, where it has the potential of optimizing results — as best seen in prostate cancer or perhaps cervical cancer. Proponents of robotic surgery would serve their cause best if they promoted it for niche areas rather than a ‘one method for all surgery’, and were factual and pragmatic in evaluation and comparison of outcomes, complications, and costs.

After having written all this I am pursuing setting up a training station for Robotic Surgery in a Center for Minimal Access Surgery Training, convinced that Robotic Surgery can, in select areas, be an important adjunct to minimal access surgery and needs structured training for better safety and outcome.