Prospective randomized trial to compare standard vs delayed approach to dorsal vascular complex (s-DVC vs d-DVC) in robot-assisted radical prostatectomy (RARP).
Patients scheduled for RARP were randomized into a 1:1 ratio to receive either s-DVC or d-DVC by two experienced surgeons.
In s-DVC arm an eight-shaped single stitch was given at the beginning of the procedure and the DVC was subsequently cut at time of apical dissection; in d-DVC arm the plexus was transected at the end of prostatectomy, prior to apex dissection and then sutured. Primary endpoint was difference in estimated blood loss (EBL) and a sample size of 226 cases was calculated; ad interim analysis was planned after 2/3 of recruitment.
Endpoint was reached at ad interim analysis after 162 cases (81 s-DVC, 81 d-DVC) and recruitment was, therefore, interrupted. Baseline and tumor characteristics were overlapping. EBL was significantly higher in d-DVC arm (mean EBL 107 vs 65 ml, p = 0.003), but without differences in post-operative hemoglobin, transfusions and complications. Overall PSM rate was higher in d-DVC arm (21.0 vs 14.8%, p = 0.323), with statistical significance relatively to organ-confined disease (15.5 vs 3.6%, p = 0.031). Apical involvement was instead significantly higher in s-DVC arm (prevalence in PSM patients 66.7 vs 23.5%, p = 0.020). Post-operative PSA, continence and potency rates were similar between groups.
Standard and delayed approaches to DVC are safe and lead to similar functional outcomes. A delayed approach exposes to a higher risk of PSM in organ-confined disease but with a lower risk of apical involvement.
Journal of robotic surgery. 2018 Jul 13 [Epub ahead of print]
Alessandro Antonelli, Carlotta Palumbo, Alessandro Veccia, Simona Fisogni, Stefania Zamboni, Maria Furlan, Simone Francavilla, Marco Lattarulo, Enrico De Marzo, Giuseppe Mirabella, Angelo Peroni, Claudio Simeone
Department of Urology, Spedali Civili Hospital, University of Brescia, Piazzale Spedali Civili 1, 25123, Brescia, Italy., Department of Urology, Spedali Civili Hospital, University of Brescia, Piazzale Spedali Civili 1, 25123, Brescia, Italy. ., Department of Pathology, Spedali Civili Hospital, University of Brescia, Piazzale Spedali Civili 1, 25123, Brescia, Italy.