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European UrologyVolume 61, issue 5, pages e41-e52, May 2012
Remarks about Remarkable Surgical Outcomes
Published online 24 December 2011, pages 885 - 886
Refers to article:
Open Radical Retropubic Prostatectomy Using High Anterior Release of the Levator Fascia and Constant Haptic Feedback in Bilateral Neurovascular Bundle Preservation Plus Early Postoperative Phosphodiesterase Type 5 Inhibition: A Contemporary Series
Accepted 24 November 2011
May 2012 (Vol. 61, Issue 5, pages 878 - 884)
This prospective series from the Mayo Clinic attempts to update and refine the technique for open radical prostatectomy (ORP) for the treatment of localized prostate cancer . The authors propose that the results of ORP can be remarkable with meticulous technique in the hands of an extremely experienced surgeon using ×4.3 optical loupes; the high release of the apical prostatic fascia with transection of the urethra just at the verumontanum and avoidance of apical cautery; haptic feedback to identify potential positive margins; and a daily, long acting phosphodiesterase type 5 inhibitor (PDE5-I), often supplemented as needed by the use of another PDE5-I. Indeed, in 123 of 197 consecutive patients (one wonders what the exclusion criteria were), 89% of men either had or thought they could achieve adequate erections for intercourse; 95% used no pads by 1 yr, with only one patient using two pads for incontinence from an overactive bladder; and 1% had positive margins. These results are truly remarkable. The authors state that open surgeons “need not be deterred by the sweeping popularity of RARP [robot-assisted radical prostatectomy].”
Having led a national prospective randomized multi-institutional surgical trial for incontinence in which patients were randomized under anesthesia (National Institute of Diabetes and Digestive and Kidney Diseases Stress Incontinence Surgical Treatment Efficacy Trial [SISTEr]) after standardizing two surgeries and having proctors confirm competency, and as someone who primarily performs RARP, I will immediately state my biases. I do not denigrate such outstanding results, rather I make a plea that, as a surgical specialty, we must move beyond single-institution, single-surgeon, nonrandomized, noncomparator surgical trials .
With the operating author recognized as one of the most experienced open radical prostatectomists in North America, can we infer that these results are generalizable? Are potency rates the result of technique or patient selection (obese patients put on diets, mean age of 58 yr, high-dose PDE5-I)? Is it disingenuous to claim high rates of potency when only 12% of men can achieve satisfactory erections off a PDE5-I? Are low positive margin rates the result of haptic feedback or patient selection with 76% Gleason 6 and 20% Gleason 7, and 97% pT2c or less? And are continence rates related to young age and independent factors such as mass of the external sphincter? Is the population that travels to the Mayo Clinic generalizable based on socioeconomic factors, which have been shown to influence potency and continence rates  and ? Does brand loyalty to institution or surgeon X bias subjective reporting, even to a third party? Without pad weights, office stress tests, nocturnal tumescence monitoring, or some other more objective measures, are third-party questionnaires enough of an outcome measure? In the absence of a randomized trial to minimize confounding variables and with numbers adequately powered to detect differences of a few percent, I believe we lack robust data on outcomes for ORP versus RARP. Yet we cannot always fund or execute randomized trials—the SISTEr trial at one time cost $5 million per year, and getting surgeons to agree on technique and outcome measures for SISTEr took >1 yr—and thus are always settling for lower levels of evidence that, depending on the hypothesis, may even be preferable .
After decades of experience with open prostatectomy, has the sweeping popularity of RARP been the result of marketing or the desire of surgeons to improve their results? Except for a handful of our most experienced “open” colleagues, remarkable results were never achieved by low-volume, and maybe even by high-volume, urologists. Similarly, claims-based data suggest that outcomes for minimally invasive prostatectomy in the United States are far from those achieved by selected sites or by surgeons reported in the literature, creating suspicion . Alas, if the surgeon and his or her experience is the most important variable, what is the point of a multi-institutional trial anyway? Perhaps it is to attempt to undercover the truth. If one's results in surgery, as opposed to medical or device trials, are not stellar, one risks shuttering one's practice for lack of patients rather than working toward improvement. Only by deidentifying the surgeon and institution can more potentially unbiased surgical results be uncovered. Unfortunately, this has been rarely done for prostatectomy and certainly not in a randomized fashion .
We are left mostly with single-institution series reporting glowing outcomes that our patients suspect are merely marketing claims. The never-ending escalation of claims and counterclaims only creates confusion in the minds of patients who shop around after reading disparate results, only to eventually wonder why their outcomes do not mimic those reported. Maybe the key to better patient satisfaction and improved subjective outcomes is the same as is jokingly stated for successful marriage: low expectations. For RARP patients, expectations—especially for potency—are high .
As the editor of a surgical journal, and editorializing in another, maybe journal editors are at fault for continuing to accept surgical series without demanding a higher level of evidence or quality of data for procedures after the first few initial reports. This is not to deny there is often value to minor modifications and refinements that may improve outcomes. But for one defined time period, can we at least resolve whether it is our modification, unconscious patient selection, outcome measures, or learning curve that actually “improved” the results? Those experts sitting on guideline panels recognize these dilemmas in interpreting our surgical literature. Comparison with a retrospective cohort, even for the same surgeon, may be unreliable.
Ultimately, is the technique generalizable, and if not, should we continue to promote it? As a specialty, should we wait to accept a procedure until at least a predetermined percentage (30%? 50%?) of colleagues obtain similar results? Heresy, I know, but recognizing that a few colleagues are gifted technicians is not the same as recommending a procedure to patients. Concern is being raised that much of what is being published in the scientific literature is not reproducible . When this occurs in surgery, we merely attribute it to the skills of one surgeon versus another. But the desire to adopt the latest procedure is overwhelming and is rewarded by fame, if not financials. Perhaps the best follow-up to this report would be a randomized trial of surgeons with similar experience in open prostatectomy adopting or not adopting the proposed refined techniques to determine what modifications that seem reasonable produce reproducible outcomes that are superior to a previous technique. Now that would be remarkable!
Conflicts of interest
The author has nothing to disclose.
-  J.M. Hubanks, E.C. Umbreit, R.J. Karnes, R.P. Myers. Open radical retropubic prostatectomy using high anterior release of the levator fascia and constant haptic feedback in bilateral neurovascular bundle preservation plus early postoperative phosphodiesterase type 5 inhibition: a contemporary series. Eur Urol. 2012;61:878-884 Abstract, Full-text, PDF, Crossref.
-  M. Albo, Urinary Incontinence Treatment Network. The Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr): a randomized trial of Burch colpopexy versus autologous rectus fascial sling for the treatment of stress urinary incontinence. New Engl J Med. 2007;356:2143-2155 Crossref.
-  A.E. Nilsson, M.C. Schumacher, E. Johansson, et al. Age at surgery, educational level and long term urinary continence after radical prostatectomy. BJU Int. 2010;108:1572-1577
-  P.I. Karakiewicz, N. Bhojani, A. Neugut, et al. The effect of comorbidity and socioeconomic status on sexual and urinary function and on general health-related quality of life in men treated with radical prostatectomy for localized prostate cancer. J Sex Med. 2008;5:919-927 Crossref.
-  J.C. Singh, P. Dahm. Evidence-based urology in practice: what are levels of evidence?. BJU Int. 2009;103:860-861 Crossref.
-  J.C. Hu, X. Gu, S.R. Lipsitz, et al. Comparative effectiveness of minimally invasive vs open radical prostatectomy. JAMA. 2009;302:1557-1564 Crossref.
-  C.B. Begg, E.R. Riedel, P.B. Bach, et al. Variations in morbidity after radical prostatecomy. N Engl J Med. 2002;346:1138-1144 Crossref.
-  F.R. Schroeck, T.L. Krupski, S.B. Stewart, et al. Pretreatment expectations in patients undergoing robotic assisted laparoscopic or open radical prostatectomy. J Urol. 2012;187:894-898 Crossref.
-  Naik G. Scientists’ elusive goal: reproducing study results. Wall Street Journal. December 2, 2011. http://online.wsj.com/article/SB10001424052970203764804577059841672541590.html. Accessed December 6, 2011.
University of Virginia, Urology, Box 800422 Hospital Drive, Charlottesville, VA 22908, USA
© 2012 Published by Elsevier B.V.
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