Comparative data on open and robot-assisted prostatectomy in “low caseload” facilities

A newly reported Swiss study provides us with what appear to be some sound comparative data on the relative merits of open radical prostatectomy (RP) and robot-assisted radical prostatectomy (RALP) at a center with a relatively low-volume caseload.

Di Pierro et al. have compared short-term perioperative, oncologic, and functional outcomes from two consecutive series of patients, all of whom were diagnosed with localized prostate cancer and who elected to receive surgical treatment. All data were collected prospectively, and included patients’ baseline characteristics, perioperative and postoperative outcomes, and complications. Study endpoints included oncologic data (positive margins, post-surgical PSA levels), perioperative complications, urinary continence, and erectile function at 3 and 12 months of follow-up.

The key data reported by the authors are as follows:

  • 75 consecutive patients underwent  an open RP and were followed for at least 12 months.
  • 75 consecutive patients underwent RALP (which included all patients treated during the initial “learning curve” for use of RALP) and were followed for a median of 12 months.
  • Preoperative baseline characteristics of patients from the two groups were comparable.
  • Positive surgical margins occurred in 32 percent of open RP patients and in 16 percent of RALP patients (p = 0.002).
  • At 3 months post-surgery
    • The PSA value was < 0.2 ng/ml in 91 percent of open RP patients  and 88 percent of RALP patients (p = 0.708).
    • Continence rates were 83 percent for open RP patients and 95 percent for RALP patients (p = 0.003).
    • Recovery of erectile function with and/or without the use of PDE5 inhibitors (like Viagra) occurred in 12/49 open RP patients (25 percent)  and 25/37 RALP patients (68 percent) (p = 0.009).*
  • At 12 months post-surgery
    • The PSA value was < 0.2 ng/ml in 87 percent of open RP patients and 89 percent of RALP patients (p = 0.36).
    • Continence rates were 80 percent for open RP patients and 89 percent for RALP patients (p = 0.092).
    • Recovery of erectile function with and/or without the use of PDE5 inhibitors (like Viagra) occurred in 12/47 open RP patients (26 percent)  and 12/22 RALP patients (55 percent) (p = 0.009).*
  • Major complications occurred in 28 percent of open RP patients and 7 percent of RALP patients (p = 0.025), as assessed using the modified Clavien system.
  • Minor complications occurred in 24 percent and open RP patients and 35 percent of RALP patients (p = 0.744), again based on the modified Clavien system.

The authors conclude that, “Despite a limited caseload and including the learning curve, RALP offers slightly better results than RRP in terms of PSM, major complications, urinary continence, and erectile function.”

Now there are some comments that we should make in order to clarify these data.

First, it needs to be noted that post-surgical erectile function was assessed only in patients who claimed to be potent without the need for use of phosphodiesterase type 5 (PDE5) inhibitors prior to their surgery.

Second, the abstract of the paper does not tell us over what timeframe these patents were treated. Was it a year or 2 years for example? How long ago where these patients treated? These data (probably available in the full text of the paper) would help to clarify the caseload at this institution.

Third, it is not entirely clear how many surgeons was involved. Was this one surgeon who first treated 75 patients using an open RP and then the next 75 patients using RALP? Or was it two surgeons — one doing open RPs and the other doing RALPs — during the same timeframe? If it was the latter, then the inherent skill levels of the two individuals may be an important factor in then outcomes. If it was the former, then the surgeon in question appears to have transitioned from doing open RPs to RALPs with a relatively high degree of ease and speed.

The bottom line would appear to be that at least some surgeons at relatively low caseload institutions can carry out RPs and RALPs with a relatively high degree of skill. Of course this was never really in question. What this study does not help us to understand is how to find the surgeons at low caseload institutions who do in fact have such a skill level!

5 Responses

  1. Physicians should be legally required to provide patients with background information that forces patients to understand the likely outcomes of the treatment they choose. Physicians need to provide an accurate count of the number of procedures by technique they’ve completed by demographic profile of patients. They also need to provide their personal and their practices’ complications data disaggregated by age, a pre-surgical functionality index, and whether or not “nerve-sparing” was attempted. They need to be absolutely transparent in whether or not they will be allowing medical residents, or otherwise less-than-fully trained medical staff to perform any part of the procedure. They need to provide patients with a description of the methodology they use to track the outcomes of their work or they need to provide patients with a statement explaining why they have chosen not to track the outcomes of their work (& that it’s commonplace in the field to do follow-up).

    The pre-operative potent men in this study were likely told that they had a “reasonable” chance of recovering erectile function. Fifty to 75 percent of them were lied to. It’s time for a little more honesty regarding whether or not prostate cancer can be treated without devastating, life-altering side effects. In approximately half of all cases it cannot. Enough! If we can’t trust you about this, why should we trust you about anything else.

  2. The “New” Prostate Cancer InfoLink wishes to be very clear that we do not agree at all with most of the statements in the prior post.

    Physicians have moral and ethical obligations to inform and educate their patients about their medical conditions, how they can be treated, and the risks that are associated with such treatment (or non-treatment). However, any attempt to legislate what information needs to be provided to a specific patient is simply ridiculous. Every patient is different. It should also be noted that every patient also has a moral and ethical obligation to educate him- or herself about his or her health and its management. The obligation does not all lie on the physician. Why? Because there are profound differences of opinion within the clinical community about how to manage most health disorders.

    If we are going to legislate what information physicians must provide to patients, we would be wise to previously legislate that patients tell their physicians the truth … something that happens probably less than half the time in physician-patient conversations.

    Patients have an absolute right to make their own decisions — however stupid they may seem to some third party. There is absolutely no way that a physician can accurately advise an individual patient of the “likely outcome” of a specific treatment on a specific day. If there was, the present writer would have died in infancy and again about 5 years ago.

    Last but by no means least … If every physician had to track outcomes data in the way suggested above, the number of physicians needed to treat patients in America would quadruple overnight. Apparently Tracy has no idea at all of the amount of work involved in compiling such databases … or the difficulty of getting patients to cooperate with that type of research. Even the most sophisticated national cancer databases, such as those in Sweden, do not compile the type of data Tracy is seeking.

  3. Sitemaster,

    Great answer.

    Referring to the study: there is no way to provide the detailed, profiled data Tracy asks for. The sample is too small. The other question is whether we want physicians to treat patients or to spend their day filling out questionnaires and raising the cost of health care.

    I wonder where Tracy got the information that ‘The pre-operative potent men in this study were likely told that they had a “reasonable” chance of recovering erectile function’ and how she reached the conclusion that “Fifty to 75 percent of them were lied to. ”

    I meet with numerous prostate cancer patients and most of them prefer ED to death by prostate cancer. This is, however, a personal choice.

  4. How in the world are individual consumers capable of making an informed decision about their treatment if physicians are not required to be forthcoming about their experience and skills? Are you really arguing that a patient’s individual condition is the only factor affecting patient outcomes – that there’s so little variation in physician skill that an individual physician’s skills has no tangible impact on outcomes?

    Generalized outcomes data are just as meaningless when it comes to making an individual decision (& living with your personal outcomes) about whether or not to allow any given physician to proceed with a treatment as they are for predicting the outcome for an individual patient (because they’re ‘different’, as you point out).

    Continuing the ‘caveat emptor’ approach to a disease that has been established as highly over-treated combined with a despairing record of capacity to accurately diagnose ‘true’ risk as well as improve the ‘side effects’ of treatment means that every year hundreds of thousands of men have to gamble their QoL on whether or not a given physician is willing to be honest about what he knows how to do well or poorly.

    What’s so hard about requiring a physician to own their relative experience in delivering various forms of treatment? Is it so unreasonable for a physician to answer questions like: ‘How many RALPs have you done?’ or ‘Of the men under 60 who were fully sexually functional before their treatment, how many recovered afterward?’ or ‘Will you actually be holding the scalpel throughout my surgery or will you be supervising a resident?’

    Even for an informed consumer who knows to ask such questions, the anxiety of the diagnosis and the potential of life-threatening risk, certainly plays into whether or not they feel compelled to accept a refusal to answer such questions and proceed with treatment regardless, as does living in geographic areas with a limited market of physicians and limitations of insurance coverage, which can sometimes be loosened if a patient can prove there’s inadequate resources available within a network.

    Just as every ‘patient’ (who also happens to be a fully-fledged human with a whole life to lead, & is not a merely diseased prostate to treat) is ‘different’, so every physician is ‘different’, has a ‘different’ clientele, and a ‘different’ set of experiences, skills and outcomes.

    It is an inherently vexed position to contend that patients should be satisfied with making their treatment decisions based on generalized population data (that may or may not reflect ANYthing to do with the actual physicians they are considering using) while being told at the same time that there’s no way to predict possible outcome for them because they are ‘individuals’. Surely, every physician knows how many procedures they’ve conducted (they bill for them, right?). Surely, every physician conducts follow-up to understand if more treatment is needed and to track potential progress of disease and/or ‘side effects’ of the disease. Surely, every physicians collects demographic and medical history in order to recommend treatment options in the first place. Surely, every (ok, most or many) physician(s) understands they’re not statisticians or record keepers (I’m guessing most docs don’t do their own billing or appt. setting) and wouldn’t feel obligated to track their outcomes themselves (thus, we wouldn’t really have to quadruple the number of treating physicians in order to track outcomes). Sure, requiring individual physicians and practices to track outcomes would add cost to operating a practice, but if consumers and advocates demanded physician-level outcomes data, this argument would quickly be subsumed into the overall cost of operating a medical practice (&, theoretically, should be reduced by the emergence of EMR technology).

    One thing’s for sure, we’ll never have improved QoL outcomes for PCa if we refuse to track those outcomes at all. The ‘caveat emptor’ approach means that men have to simply guess, roll the die, based on… what? intuition? how posh a Dr.’s office appears? word of mouth? undocumented, unsupported claims by a physician?

    Would you leave an infant in a daycare that wouldn’t release their inspection results? Would you put a disabled relative in a long-term care facility that refused to release its neglect and abuse rates? Would you have surgery in a hospitable that wouldn’t report its secondary infection rates? Would you subject your child to a flu shot that hadn’t been tested for efficacy and safety? We spend resources on tracking the outcomes of health care all the time.

    PCa is a particularly thorny disease to treat – great successes in keeping folks going with deplorable failure rate in protecting QoL. Men have a right to know and understand not just their general risk, but what side of the risk equation an individual physician puts them on. That’s all.

  5. I’m going to restrain myself from commenting on the item above.

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