Articles

Re: A Prospective, Non-Randomized Trial Comparing Robot-Assisted Laparoscopic and Retropubic Radical Prostatectomy in One European Institution

By: Vipul Patel

European Urology, Volume 60 Issue 1, September 2011, Pages 599-600

Published online: 01 September 2011

Abstract Full Text Full Text PDF (52 KB)

Ficarra V, Novara G, Fracalanza S, et alBJU Int 2009;104:534–9Expert's summary:This prospective nonrandomized trial compared 105 patients who underwent open radical prostatectomy (ORP) with 103 patients who had robot-assisted radical prostatectomy (RARP). Patients in both arms underwent the same data collection protocol, including serial validated questionnaires to assess urinary continence (International Consultation on Incontinence Questionnaire–Urinary Incontinence), potency (International Index of Erectile Function), and complications (Clavien). Urinary and sexual functions were evaluated before surgery and at 12 mo. Besides the fact that patients in the robotic arm were younger (61 yr vs 65 yr; p<0.01), the remaining preoperative characteristics including performance status, body mass index, prostate-specific antigen, and tumor stage and grade did not differ between the study arms. The following main results were found for RARP versus ORP, respectively: overall positive surgical margins (PSMs) of 34% versus 21% (p was not significant), 12% PSMs in pT2 disease for both groups (p was not significant), perioperative blood transfusion rate of 1.9% versus 14% (p<0.01), perioperative complication rate of 10% versus 11% (p was not significant), continence rate at catheter removal of 69% versus 41% (p<0.001), continence rate at 12 mo of 97% versus 88% (p<0.01), and mean time to continence of 25 d vs 75 d (p<0.001). Among preoperatively potent patients who underwent bilateral nerve sparing, 81% and 49% of those who underwent RARP and ORP, respectively, were potent at 12 mo. Similarly, the mean time to recovery of erectile function was 3.9 mo and 6.7 mo for RARP and ORP, respectively.Expert's comments:Although results of high-volume centers have demonstrated that RARP offers results that are at least equivalent if not better than those of ORP [1], the reproducibility of these findings in centers with lower caseloads has long been a matter of debate. The lack of prospective comparisons and the publication of high-impact studies, which have generally used poor methodologies, have further increased doubts about the real benefit of robotic prostatectomy [2]. This series is the first to prospectively compare robotic and open prostatectomy side by side. Two robotic surgeons in the beginning of their learning curves, with prior experience of 50 cases each, were compared with four experienced open surgeons with prior experience of 400 patients each. The results reflect the different stages of the learning curve. For example, rates of PSMs, overall complications, and urine leakage for both approaches are higher than those reported for either technique by high-volume centers [3] and [4] Even though robotic surgeons were much less experienced than their open counterparts, results show that the robotic procedure had higher rates of recovery of erectile and urinary function and a lower rate of urethrovesical anastomosis leakage. In contrast, overall PSMs, although not significant, were higher for the robotic approach. This is expected, considering the above-mentioned differences in surgical experience among participating surgeons.

Results of this study are encouraging and should inspire new surgeons to go into robotics, as they suggest that after only 50 cases, robotic surgeons can expect results that are at least comparable to those of highly experienced open surgeons. Superior visualization and tremor control, together with improved instrumentation and ergonomics gives robotic technology the potential to perform surgery in a precise and delicate way, especially in places with difficult access such as the male pelvis. However, technological breakthroughs will not be translated into improved outcomes unless they are complemented with a capable surgeon and a well-integrated surgical team.

The lack of randomization is a main drawback of this study. In this context, patients who underwent RARP were younger and had fewer comorbidities than those who had open surgery, and this might have influenced the results for erectile function and continence recovery. However, patient preference is now clear, and it might be not possible to perform such randomization anymore. Results of this well-designed prospective trial suggest superiority of the robotic approach in this center with a limited caseload, and these findings are further corroborated by the results of a similar recently published prospective trial [5].

Robotic technology has been adopted broadly in most of the academic and private centers in the United States, and it is rapidly increasing in most western European countries. Residency and fellowship programs have largely incorporated robotics into the curriculum, and qualified mentorship and multimedia learning is more available than ever.

It has taken some time for the increased potential of robotic surgery to translate into improved patient outcomes. We believe that these encouraging results represent the beginning of a new era in robotic surgery, in which the current generation of surgeons will consistently demonstrate the superiority of the robotic approach.

Conflicts of interest

The author has nothing to disclose.

References

  • [1] V.R. Patel, R.F. Coelho, S. Chauhan, et al. Continence, potency and oncological outcomes after robotic-assisted radical prostatectomy: early trifecta results of a high-volume surgeon. BJU Int. 2010;106:696-702 Crossref.
  • [2] 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.
  • [3] A. Vickers, F. Bianco, A. Cronin, et al. The learning curve for surgical margins after open radical prostatectomy: implications for margin status as an oncological end point. J Urol. 2010;183:1360-1365 Crossref.
  • [4] R.F. Coelho, K.J. Palmer, B. Rocco, et al. Early complication rates in a single-surgeon series of 2500 robotic-assisted radical prostatectomies: report applying a standardized grading system. Eur Urol. 2010;57:945-952 Abstract, Full-text, PDF, Crossref.
  • [5] G.B. Di Pierro, P. Baumeister, P. Stucki, J. Beatrice, H. Danuser, A. Mattei. A prospective trial comparing consecutive series of open retropubic and robot-assisted laparoscopic radical prostatectomy in a centre with a limited caseload. Eur Urol. 2011;59:1-6 Abstract, Full-text, PDF, Crossref.

Footnotes

Global Robotics Institute, Florida Hospital-Celebration Health, Urology, 410 Celebration Place, Suite 200, Celebration, FL 34744 USA

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