The Emperor’s New Clothes?
I believe treatment of prostate cancer by removal of the prostate with robot-assisted laparoscopic surgery could set back by years some of the gains that have been achieved in the successful treatment of prostate cancer.
The surgical technique, also referred to as “minimally invasive radical prostatectomy (MIRP),” “robotic prostatectomy” or the “DaVinci prostatectomy” has had unprecedented advertisement and hype.
Somebody has to point out that the Emperor’s new clothes are not so “Magnificent,” “Excellent,” and “Exquisite as some would have them believe.” Like the boy in Hans Christian Anderson’s tale, someone has to stand up and say, “But he hasn’t got anything on.”
In a previous Quest (Winter, 2008 See Website: www.drcatalona.com), I referred to three recent studies from Memorial Sloan Kettering, Harvard, and Duke that showed the statistical disadvantage of laparoscopic prostatectomy in: cancer control, scarring at the bladder outlet, return visits to the emergency room, repeat hospital admissions, return visits to the operating room, urinary incontinence, and patient satisfaction.
Also, I referred to articles from Vanderbilt University and the University of Michigan showing no advantage for robotic surgery in the postoperative recovery and return to normal activities.
Vein Graft Harvesting for Coronary Artery Bypass Surgery
New surgical techniques do not always stand the test of time. A striking recent example is harvesting of vein grafts from the thighs to be used in open heart surgery to bypass blockages in the coronary arteries.
Vein graft harvesting for coronary artery bypass surgery performed with open surgery is sometimes associated with complications and discomfort.
Endoscopic (“minimally invasive”) harvesting was introduced in 1966, in hopes it would reduce the length of stay in the hospital and postoperative wound complications. Based on the results of small studies with short follow-up, and that did not evaluate clinically important outcomes, endoscopic harvesting became the predominant method, accounting for 70% of procedures performed in the U.S. in 2008.
However in 2009, a large study published in the New England Journal of Medicine (July 16, 2009) showed that patients undergoing endoscopic harvesting had a higher rate of vein graft blockage requiring further cardiac surgery and a higher rate of death from heart attacks than with the “gold standard” open harvesting.
Some outcomes are more important than others.
Now, a new study* (Hu, Harvard) published in the Journal of American Medicine (JAMA) adds further evidence concerning the disadvantages of “minimally-invasive” surgery.
The purpose of the study was to determine the comparative effectiveness of MIRP (minimally invasive radical prostatectomy) and RRP (open retropublic radical prostatectomy).
The motivation for the study was the rapid increasing use (of MIRP) despite limited data on outcomes and greater costs compared with RRP.
In fact, robotic-assisted MIRP increased from 1% to 40% of all radical prostatectomies from 2001 to 2006 and is an even greater percentage today.
The appeal is clear. It’s hard to miss the widespread direct-to-consumer advertising that markets several claimed benefits of robotic-assisted MIRP.
Most prostate cancer patients have similar priorities. First, they want to survive. Next they want to remain continent. Third, they want to preserve their potency. These are their main priorities, but they want all three. Urologists call it the “Trifecta.” And, of course, men want to achieve it as painlessly and quickly as possible and without unpleasant side effects.
Often, after a patient admits that he needs treatment, he looks for an “Easy Button” and that search leads him to options like the DaVinci prostatectomy.
Clearly, the ads are effective but recent studies show the surgical technique is not as advertised.
Outcomes From Treatment
Hype and marketing have definitely driven patient requests for MIRP, but more important than talking about the reasons for increased robotic prostatectomies is discussing the outcomes from the treatment.
I do not believe that the robotic prostatectomy is as safe as open prostatectomy for achieving complete cancer excision and simultaneous nerve sparing.
In addition, compared to open prostatectomy, there is no evidence of superior cancer removal or better functional outcomes with robotic prostatectomy to justify the substantial increase in cost.
In Hu’s study of men undergoing MIRP vs RRP – beginning with a bias in favor of robotic prostatectomy by including data from U.S. regions where robotic surgery is most frequently performed and having less follow-up time to detect tumor recurrence and urologic complications for robotic surgery than for open surgery patients undergoing MIRP experienced shorter hospital stays, fewer respiratory and miscellaneous surgical complications and strictures, and similar postoperative use of additional cancer therapies,
But MIRP was associated with significantly more genitourinary complications, incontinence and erectile dysfunction.
Hu’s study concludes:
Until comparative effectiveness of robotic-assisted MIRP can be demonstrated, open retropublic radical prostatectomy, with a 20-year lead time for dissemination of surgical technique relative to MIRP, remains the gold standard surgical therapy for localized prostate cancer.
Choosing the Right Option
“Robotic prostatectomy is like the Emperor’s New Clothes, and somebody has to stand up and say, ‘But he hasn’t got anything on.’”
I have nothing against laparoscopic (or robotic) surgery for operations well suited to their application. For instance, if I had to have my gallbladder removed, I would want it done laparoscopically. The gallbladder has only an artery, vein and a duct and, in most cases, the operation involves a relatively simple removal of the gall bladder.
A radical prostatectomy is a far different type of surgery, involving not only removal of the prostate gland but also reconstruction of the urinary tract. The surgeon must carefully remove the entire prostate gland intact without damaging the adjacent neurovascular bundles that are responsible for producing erections and then reconstruct the bladder and the urethra, without creating scar tissue, so that the urine passes freely but not so freely that the patient is incontinent.
With a radical prostatectomy, the surgeon looks into the pelvis and sees the prostate gland cradled by two neurovascular bundles, one on each side. The surgeon must dissect in the exact proper tissue plane to remove the prostate from between the two neurovascular bundles without permanently damaging the nerves or cutting into the prostate gland, or worse, leaving part of the prostate gland behind.
Using a robot, the surgeon has no sense of touch or tactile feedback at all. Dr. Patrick Walsh, of Johns Hopkins, says “It’s like trying to read Braille with chopsticks.” Moreover, the robotic surgeon frequently uses electrocautery or heat to burn the prostate out or to control bleeding, and the heat may permanently damage the nerves responsible for erections.
With patients treated for prostate cancer, the most important outcomes are: Am I cured of my cancer? Am I continent? Can I have erections sufficient for intercourse? These questions have been answered and validated with long-term follow-up for open prostatectomy.
Most importantly, the robotic prostatectomy has no track record in terms of long-term cancer control. If small amounts of cancer are left behind, they may not become apparent for years.
I do not believe the laparoscopic or robotic prostatectomy is as safe a cancer operation as open radical prostatectomy, and I do not believe that nerve-sparing can be as readily or safely accomplished.
Now, objective data from comparative studies of MIRP and RRP confirm my concerns about robotic prostatectomy.
The jury is still out with robotic prostatectomy. Time will tell but, so far, much of the important evidence is not encouraging. It suggests that with robotic prostatectomy, complications may occur more frequently and be more serious and that the simultaneous objectives of continence, potency, and cancer control may be compromised.
“Comparative Effectiveness of Minimally Invasive vs Open Radical Prostatectomy” JAMA 2009 Vol. 302 No. 14, October 14, 2009 (Hu, Gu, Lipsitz) (The Study population was men 65 years of age and older: 1938 of whom underwent MIRP and 6899 RRP.)