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AUA 2018

AUA 2018: Outcomes of a Phase III Randomized Controlled Trial Comparing Preventive versus Delayed Ligation of Dorsal Vascular Complex During Robot-Assisted Radical Prostatectomy

San Francisco, CA (UroToday.com) Since the anatomic approach to radical prostatectomy was first described, there have been many attempts to improve the technique. Such innovation has been particularly notable since the widespread adoption of robotic assisted radical prostatectomy. Modifications including the Rocco stitch and Retzius sparing have been undertaken in an attempt to improve clinical outcomes. In a moderated poster presented at the American Urologic Association Annual Meeting, Dr Palumbo and colleagues from Brescia, Italy report on their phase III randomized controlled trial comparing preventative ligation of the dorsal venous complex (DVC) during robotic assisted radical prostatectomy to delayed ligation, following its transection. 



Patients were randomized to receive either preventative ligation of the DVC using a 1-O Monocryl on a CT-1 needle prior to the bladder neck dissection or delayed ligation using a 3-O Monocryl on a UR-6 needle following completion of the prostatectomy. In both cases, the authors performed a traditional transperitoneal approach to prostatectomy. Considering the primary endpoint of estimated blood loss, the authors powered the study to detect a difference of 30cc which resulted in a sample size of 226. Secondary outcomes included transfusion rates, positive surgical margins, PSA levels at 1month post-surgery, and continence. 

The authors recruited 243 patients undergoing robotic assisted radical prostatectomy at their institution, 136 of whom were randomized to preventative ligation and 107 to delayed ligation. 26 patients in the preventative ligation group actually received delayed ligation and 8 patients in the delayed ligation group received preventative ligation. In keeping with a per-protocol approach, the authors excluded these individuals from further analysis. 

Baseline characteristics were similar between participants in the two groups. While estimated blood loss was higher for patients in the delayed ligation group (107 cc, standard deviation 134cc) versus the preventative ligation group (91cc, standard deviation 120cc), this difference did not reach statistical significance. Similarly, transfusion rates were comparable (1.6% vs 1.3%, p=0.85). Rates of positive surgical margins were equivalent between the two groups (19% and 21%), though patients undergoing preventative ligation were more likely to have a positive apical margin. There were no differences in post-operative PSA levels or 1-, 3-, or 6-month continence rates. 

In summary, the authors find no significant difference in clinical outcomes including blood loss or the need for transfusion for patients undergoing preventative or delayed ligation of the DVC in robotic assisted radical prostatectomy. They concluded that delayed ligation may allow for better management of the prostatic apex. 

Presented: Carlotta Palumbo 
Co-authors: Alessandro Antonelli, Simone Francavilla, Marco Lattarulo, Stefania Zamboni, Alessandro Veccia, Maria Furlan, Enrico De Marzo, Angelo Peroni, Claudio Simeone 

Written by: Christopher J.D. Wallis, Urology Resident, University of Toronto, Twitter: @WallisCJDat the 2018 AUA Annual Meeting - May 18 - 21, 2018 – San Francisco, CA USA