Another case of “What you see may not be what you get”


The “New” Prostate Cancer InfoLink is more than a little concerned by the implications of a recent review that compares outcomes of open (RRP), laparoscopic (LRP), and robotic assisted (RALP) prostatectomy. In commenting on this review, UroToday has already stated that

This review is difficult to interpret, as the individual reports of types of surgical approaches are mostly not randomized nor from the same centers. A randomized trial in this area will not happen, so physicians and patients will have to evaluate surgeons and centers based upon their expertise, volumes and outcomes as well as patient preferences to decide on the type of radical prostatectomy to have.

We would go rather further and suggest that this review may be totally misleading.

The review claims that, based on an analysis of 22 published reports:

  • Mean operative time was164 minutes for RALP, compared to 227 for LRP and 147 for RRP.
  • Estimated mean blood loss was 152 mL for RALP, 406 mL for LRP and 697 mL for RRP.
  • Transfusion rates were 2.9 percent for RALP, 8.3 percent for LRP, and 24 percent for RRP.
  • Conversion to open RP occurred in 0.5 percent of RALPs and 1.5 percent of LRPs.
  • Mean time to foley catheter removal was 8.4 days for RALP, 6.9 days for LRP, and 8.4 days for RRP.
  • Mean overall surgical complication rate for RALP was 6.6 percent, compared to 15.6 percent for LRP and 10.3 percent for RRP.
  • Death rates were low for all procedures.
  • RALP had the lowest positive surgical margin rate at 12.5 percent, LRP 19.6 percent, and RRP 23.5 percent.
  • The RRP group included a relatively higher proportion of pT3 tumors.
  • At 12 months, continence was 98 percent with RALP and LRP, compared with up to 92.1 percent for RRP (although the variability in reporting continence is likely influential).
  • Twelve months following bilateral nerve-sparing, potency was up to 97 percent for RALP, 79 percent for LRP and 86 percent for RRP.

Frankly, the “New” Prostate Cancer InfoLink finds some of these claims to be extraordinary. They are incompatible, for example, with a recent article published by Toujier et al., which (as far as we are aware) is the only large, prospective study comparing LRP to RRP, and (also as far as we are aware) there is no large, published, prospective comparison of LRP or RRP to RALP.

The claim of 97 percent potency for RALP at 12 months is simply nontenable. There is no standard definition of “potency” at this time, but, based on the practical idea that “potency” should mean the ability to have satisfactory sexual intercourse at will (with or without the use of PDE5 inhibitors such as Viagra or Cialis), we know of no surgical technique that can achieve such potency levels following nerve-sparing radical prostatectomy of any type within 12 months.

The review included published studies of comparisons of not less than 40 patients. However, since it is now widely accepted that it may take up to 250 patients for any surgeon to achieve a high level of skill with any specific form of radical prostatectomy, we would consider that any viable comparison of two surgical techniques would require analysis of data that included at least 250 surgeries of each type being compared. We do not currently know whether any of the comparative trials reviewed in this paper meets such a criterion.

We would advise patients that the data provided in this review is potentially highly misleading. The ability to use any surgical technique to provide high quality outcomes is dependent on the skill and volume of procedures carried out by each individual surgeon. Inexperienced surgeons using RALP will achieve relatively poor results, as will inexperienced surgeons using any other technique.

3 Responses

  1. Mike,

    How long have LRP and RALP been done? Do they have similar learning curves? Why is here a difference in Margins?

    Is it true that surgeons are switching to RALP from LRP as it says in the abstract by Martínez-Salamanca JI, Romero Otero J, Arch Esp Urol. 2007 Sep;60(7):755-65? If the answer is yes, any theories why?

    What types of surgery do the authors perform?

  2. Kathy, I have not see the actual publication cited above. The abstract does not provide detail so I won’t react to specifics. With that said, there are a few general points, many of which are surely known to you:

    1) To make valid claims about relative treatment merit requires a thoughtful prospective study design. Retrospective reviews of single-institution reports are scientifically useless in this regard. Such was the point of a recent report from the University of Florida that found that the literature on this subject is of poor quality.

    Forget about trying to understand difference in margins until you control for surgeon experience, grade, and stage. Don’t even try.

    Forget about interpreting surgical time until you control for patient size, prostate size, and surgeon experience. Four hours for LRP? See the two brothers whose photo I posted on the social network. I did both LRPs in three hours. They were thin, their prostates were average, and I have tons of experience. By contrast, a surgeon I know spent 12 hours doing a single RALP earlier this week. I don’t know about the patient but I know the surgeon has very little experience. Like I said, single arm retrospective reports are useless as a basis for valid conclusion about relative technique merit. All I can infer is someone may have had a huge prostate or the surgeon may have been inexperienced. How does that help? It doesn’t.

    8% transfusion for LRP? I have done LRP and RALP since 1999 and last transfused a patient in the year 2000. What do we learn? That someone who published has little experience and is transfusing a lot? What does this tell me besides he needs more experience and I don’t want him to operate on me?

    What is the definition of erections? Was the definition standard across techniques?

    2) You can get the ancient history of LRP going back to 1991 in the Technical Manual that I coauthored with Vallancien and Guillonneau. It was described and lay dormant for about 8 years.

    I brought LRP back to the Americas in 1999. Subsequently, perhaps a year or two later, I was asked to consider applying a new “robot” that had been invented for cardiac surgery. I held off for a few years. Others were approached after that and decided differently.

    3) Learning curves are an interesting concept. You might argue that the learning curve for open RP is longest, in that Bill Catalona says he is still on his learning curve, learning from every new case. I would agree. Having done open, laparoscopic, “robotic” RP over 25 years I am still on my learning curve.

    4) I know surgeons who went from open to lap, open to “robotic,” “robotic” to open, and “robotic” to lap. Surgeons switch techniques and are motivated by various factors, some technical and some commercial.

    I listed 10 commandments of choosing a surgeon on the Site Map (near the bottom). Based upon 25 years of practical experience and having lived with many “mouse traps du jour” my strong belief is that for patients the key to good outcomes remains surgeon experience, commitment, and focus.

  3. LRP was first done in America on a continuing basis by Krongrad in 1998/9. RALP was first done a couple of years later, I believe. There is at least one paper published that suggests that the learning curve for RALP is shorter than for RRP or LRP. However, the data still suggest that a high skill level requires about 250 procedures regardless of the technique. With respect to positive margins, other papers have suggested that positive margin rates are higher among patients treated with RALP and LRP than with RRP, but my suspicion is that this has far more to do with where the surgeons are on the learning curve than it does on the actual technique per se.

    RALP is currently the technique of choice/fashion, particularly among the surgeons who have not spent years learning RRP or LRP. It is “very cool” and surgeons are into the “very cool.” Also, once hospitals have invested in the equipment, there is pressure to use this equipment. At least one paper presented at the AUA , however, discussed “patient regret” at having decided to undergo RALP.

    Recommend you read article entitled, “Who needs a robot — and why?” elsewhere on the site.

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