A new study published in the Journal of the American Medical Association reports that men who chose to undergo minimally invasive prostatectomy (MIRP)—often with robotic assistance—were twice as likely to suffer genitourinary complications compared with men who chose traditional, or open retropubic radical prostatectomy (RRP). However, they also spent less time in the hospital and had fewer surgical complications. Overall, neither procedure was associated with an increased need for additional cancer treatment.

This was an observational cohort study using a Medicare claims database of men with prostate cancer who underwent MIRP (n=1938) or RRP (n=6899) between 2003 through 2007. During this time period, there was an increase in MIRP from 9.2% in 2003 to 43.2% in 2006 to 2007. The study endpoints included complications at 30 days postoperatively, anastomotic strictures 1 month to 1 year postoperatively, incontinence and erectile dysfunction (ED) more than 18 months postoperatively, and postoperative use of additional cancer therapies (radiation and/or hormone therapy). More white and Asian men chose MIRP, while more black and Hispanic men chose RRP.

Using statistical adjustments that allow researchers to control for confounding factors that might influence which patients were likely to be in which treatment group and the resulting outcome, the median length of stay for men undergoing MIRP was 2 days versus 3 days for the RRP group (P<0.001). The transfusion rate was significantly lower in the MIRP versus the RRP group (2.7% versus 20.8%; P<0.001), and the postoperative respiratory complication rate was significantly lower in the MIRP group (4.3% versus 6.6%; P=0.004). Genitourinary complications were 4.7% for men in the MIRP group versus 2.1% in the RRP group (P=0.001). The rate of urinary incontinence and ED were both significantly increased in the MIRP group versus the RRP group (P=0.02 and P=0.001, respectively). The use of additional cancer therapies did not differ by either MIRP or RRP (8.2 versus 6.9 per 100 person years; P=0.35).

The major limitations of the study included that the Medicare claims database is designed to provide billing rather than clinical information. Because the survival from prostate cancer is high over the short term, a longer follow-up is required to determine whether any improvements in clinical outcomes emerge. In addition, the claims database may underrepresent men with ED, who may choose not to seek out medical care.

Despite the absence of data suggesting improved clinical outcomes, the use of MIRP has proliferated over the past 3 years. This study provides no evidence that MIRP should replace RRP as the reference standard for men with prostate cancer. In addition, MIRP is a more expensive technology and requires ongoing consideration and watchfulness regarding its incremental cost-effectiveness and clinical benefit.

Related Hayes report: Robotic Assisted Prostatectomy. This study will not immediately impact the Hayes Rating in this Hayes Medical Technology Directory report. Available at: https://www.hayesinc.com/subscribers/displaySubscriberArticle.do?articleId=2346&searchStore=%24search_type%3Dall%24icd%3D%24keywords%3D%24status%3Dactive%24page%3D5%24from_date%3D%24to_date%3D%24report_type_options%3DDirectoryReport%24technology_type_options%3D%24organ_system_options%3D%24specialty_options%3D%24order%3Datransformsort

1. Hu JC, Gu X, Lipsitz R, et al. Comparative effectiveness of minimally invasive vs open radical prostatectomy. JAMA. 2009;302(14):1557-1564. Abstract available at: http://jama.ama-assn.org/cgi/content/short/302/14/1557. Accessed November 3, 2009.

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This entry was posted on Tuesday, November 3rd, 2009 at 12:00 pm.