A Prospective Controlled Nonrandomized Trial of Robotic Versus Open Radical Prostatectomy: On Point but Still Missed?

As an experienced open surgeon, I can tell you that, in the 1990s, applications to improve outcomes through better vision—such as surgical loupes (in 1998 for me), less bleeding, and improved vision via laparoscopic approaches—were welcomed, even enticing. Along these lines, the idea that a surgical robot interface could increase vision and reduce bleeding in an intuitive, open-like fashion seemed and still seems logical and sensible. The introduction of robotic prostatectomy and its so-called rampant adoption occurred in the absence of high-level evidence of superiority over traditional open radical prostatectomy (ORP). It appears that this resulted from a number of issues including (but not limited to) the fact that robotic surgery was a privately funded technology looking for an indication. As is now very evident, radical prostatectomy (RP) provided the path to initial and subsequent adoption of this technology. But if one looks toward the introduction of any surgeon-dependent technology, the prospects of starting and or even using a randomized controlled trial (RCT) to prove superiority has major if not insurmountable roadblocks. At their core, RCTs are designed to assess a single variable, such as whether or not a pill works, and randomization manages known and unknown confounders. To study the outcomes of robot-assisted laparoscopic RP (RALP) without including a second variable, surgeon impact, a trial would require a group of open surgeons to learn (through the learning curve) the new robotic technique while keeping up their openRPskills andvolume[1]. Interestingly, two(singlesurgeon) RCTs reported comparison of laparoscopic and robotic RP by experienced surgeons and suggested the superiority of the robotic approach in terms of both continence and potency [2,3]. Both surgeons indicated simultaneous use of laparoscopic RP andRALP. Theoretically, one would expect very little difference between blood loss and invasiveness because both procedures are laparoscopic. Superiority would have to result from vision, intuitiveness, instrument differences, and their impact on continence and potency. In this month’s issue of European Urology, the comparative results of open and robotic RP for 1-yr patient-reported urinary and sexual outcomes as well as surgical margins are reported from a prospective controlled nonrandomized trial [4]. The authors and teamof surgeons are to be congratulated for pursuing, planning, and nowpresenting the results of this study with a very high level of evidence. After carefully reviewing this and the authors’ two previous publications, I concur with and do not dispute the outcomes of this report. The planning, methodology, and all aspects of this report are extremely tight and well executed. It makes sense, however, that a minimally invasive laparoscopic approach that delivers superior vision ( 12) and instrument dexterity (intuitive and tremor free) should have had superior results, including continence and surgical margins. As logic predicted, the initial publication by this group demonstrated that RALP did indeed produce expected early ‘‘laparoscopic-like’’ outcomes, that is, smaller incisions and reduced bleeding, resulting in less invasiveness and trauma [5]. The robotic group had significantly less blood loss, shorter length of hospitalization, and reduced reoperation during initial hospitalization. In similar fashion, one should expect other signs from less invasive surgery that indeedwere seen, such as fewer cardiovascular, gastrointestinal, and psychological complications at 3 mo. E U RO P E AN URO L OG Y 6 8 ( 2 0 1 5 ) 2 2 6 – 2 2 7