Monday, August 18, 2014

Journal Spotlight: Randomized Trial of Open and Robotic Radical Cystectomy

Robotic surgery disseminated rapidly over the past decade and is now the most common approach for radical prostatectomy for prostate cancer in the United States.  The dissemination of this technology was fueled by surgeon preference and a number of retrospective and case-series studies that demonstrate improvements in blood loss, convalescence, and hospital stays.[1,2]  However, randomized and/or controlled prospective studies were not performed before robotic surgery took over for prostate cancer.

There is growing interest in robotic surgery for bladder cancer.  The cystectomy (bladder removal) population is often an older, sicker population who undergoes a morbid, radical surgery.  In order to address the utility of robotic surgery for bladder cancer, researchers from MSKCC (Memorial Sloan Kettering Cancer Center) in New York City, reported the results of a small, randomized trial of open versus robotic radical cystectomy for the treatment of bladder cancer.  The results were shared as a Letter to the Editor in the July 24th edition of the NEJM (New England Journal of Medicine).

Bochner BH, Sjoberg DD, Laudone VP.  A Randomized Trial of Robot-Assisted Laparoscopic Radical Cystectomy.  N Engl J Med 2014; 371:389-390July 24, 2014DOI: 10.1056/NEJMc1405213

One-hundred eighteen (118) patients were randomly assigned to undergo open (60) or robotic surgery (58) by a number of experienced surgeons at MSKCC.  The study was designed to detect a difference in complication rates among the two types of surgery.  Given a historic complication rate of radical cystectomy of about 50%,[3] the researchers predicted robotic surgery should improve the complication rate by 20%.  The study was initially designed to enroll over 200 patients, but was stopped early when the complication rates were found to be similar at a pre-determined interim analysis.    

In fact the complication rate was 62% in the robotic group and 66% in the open group at 30 days; high-grade (severe) complications occurred in 22% and 21% respectively.  Important differences in the short-term analysis were:

  • decreased blood loss in the robotic group (mean difference, 159 cm3)
  • decreased length of surgery in the open group (mean difference, 127 minutes)

This communication was picked up by a number of medical and non-medical publications.  Given the recent skepticism regarding the use of robotic technology, as evidenced an increased reporting of complications in the gynecologic literature, and the increased associated costs with robotic technology,[4,5] a number of sources reflected on this report as a negative study. For instance, the Wall Street Journal ran with the headline, Surgical Robot Fails to Show Advantages in Treating Bladder Cancer, and stated, "This small study may cast further doubt on the benefits of Intuitive Surgical's da Vinci robot."[6]

While this study may not demonstrate a significant benefit to the robotic surgery, it does also not show any detrimental effects, increased complications or worse cancer outcomes for the patients undergoing robotic surgery.  In fact, while the robotic surgery may take longer, the significant lower blood loss may be a worthy trade-off.  In the contemporary radical cystectomy population, a group of patients that often receives chemotherapy before surgery and is subsequently anemic entering the operating room, upwards of 40% of patients will receive a perioperative blood transfusion.  This is especially significant, as recent studies indicate that blood transfusions may be linked to worse cancer outcomes in the bladder cancer population.[7]  Robotic surgery is another tool in the armamentarium of surgeons.  As found in other surgeries, outcomes are often surgeon- and experience-dependent,[8] and this study should not dissuade people from undergoing robotic surgery by an expert surgeon.  The authors and members of this study from MSKCC should be commended for running a successful study comparing a surgical innovation to standard-of-practice and should serve as a model for studies in the future.   

[1] Ficarra V, Cavalleri S, Novara G, Aragona M, Artibani W. Evidence from robot-assisted laparoscopic radical prostatectomy: a systematic review. Eur Urol. 2007;51:45-55; discussion 56. 
[2] Hu JC, Gu X, Lipsitz SR, et al. Comparative effectiveness of minimally invasive vs open radical prostatectomy. JAMA. 2009;302:1557-1564
[3] Shabsigh A, Korets R, Vora KC, et al. Defining early morbidity of radical cystectomy for patients with bladder cancer using a standardized reporting methodology. Eur Urol 2009;55:164-176
[4] Rabin RC. New Concerns on Robotic Surgeries.  The New York Times, September 9, 2013; D4. 
[5] Kolata G. Results unproven, robotic surgery wins converts. The New York Times. February 14, 2010; A1.
[6] Walker, J. Surgical Robot Fails to Show Advantages in Treating Bladder Cancer.  The Wall Street Journal.  July 23, 2014.
[7] Linder BJ, Frank I, Cheville JC, Tollefson MK, Thompson RH, Tarrell RF, Thapa P, Boorjian SA.
The impact of perioperative blood transfusion on cancer recurrence and survival following radical cystectomy. Eur Urol. 2013 May;63(5):839-45. doi: 10.1016/j.eururo.2013.01.004. Epub 2013 Jan 11.
[8] Klein EA, Bianco FJ, Serio AM, Eastham JA, Kattan MW, Pontes JE, Vickers AJ, Scardino PT.Surgeon experience is strongly associated with biochemical recurrence after radical prostatectomy for all preoperative risk categories.J Urol. 2008 Jun;179(6):2212-6; discussion 2216-7. doi: 10.1016/j.juro.2008.01.107. Epub 2008 Apr 18.


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