Four-year outcome of a prospective randomised trial comparing laparoscopic versus robotassisted radical prostatectomy Eur Urol Suppl 2016;15(3);e442
Fiori C.1 , Morra I.1 , Manfredi M. 2 , Mele F.2 , Bertolo R.2 , Cattaneo G.2 , Poggio M. 2 , Ragni F.2 , Amparore D.2 , De Cillis S. 2 , Checcucci E. 2 , De Luca S. 2 , Porpiglia F.2 1 San
Luigi Hospital, Dept. of Urology, University of Turin, Orbassano, Italy, 2 San Luigi Hospital, Dept. of Urology, University of Turin,
Orbassano , Italy INTRODUCTION & OBJECTIVES: The advantages of Robotic Assisted Radical Prostatectomy over Laparoscopic Radical Prostatectomy (RARP over LRP) have rarely been investigated in a randomised controlled trial. We have previously reported the perioperative and 1 yresults of a prospective randomized trial comparing RARP and LRP. The aim of this study was to evaluate 4-yr results from that trial. MATERIAL & METHODS: From January 2010 to January 2011, 120 patients (40-75 years) with organ-confined prostate cancer (T1-2-N0 M0 clinically staged according to TNM 2009) and to whom radical prostatectomy was proposed were enrolled and randomly assigned (using a randomization plan) to one of two groups based on surgical approach: The RARP group and the LRP group. All interventions were performed with transperitoneal anterograde technique by the same surgeon. Continence and potency were evaluated after 1, 2, 3 and 4 year. Patients were defined as continent if they did not use any pads or used one safety pad per day. In the NS-cohort, erectile function recovery with or without PDE5-I treatment was defined by using the IIEF-5 questionnaire, we considered patients to be potent with an IIEF5 score >17. Patients who experienced biochemical recurrence and required adjunctive therapy (radiation therapy and/or hormonal treatment) were registered and compared. Student’s t-test, Mann-Whitney test, Chi-Square test, Pearson Chi square test and multiple regression analysis were used for statistics. RESULTS: The two groups (RARP n= 60, LRP n=60) were comparable in terms of demographic data; no differences in terms of pathological results were found. The continence rate was higher in the RARP group at 1 y time-point: The overall continence rate was 95.0% and 83.3%, respectively (p=0.042); RARP vs. LRP respectively) and these rates did not change significantly after 2, 3,and 4 years. Twelve months after surgery, among preoperative potent patients treated with nerve-sparing techniques (35 in both groups) the rate of erection recovery was 80.0% and 54.2%, respectively (p=0.020). These rates progressively increased until 88.5% and 62.8% respectively, 4 y after surgery. Stepwise regression analysis showed that surgical approach was an independent prognostic factor for continence at every time points. Overall, during the follow up, 12 patients in the RARP group and 11 in the LRP group (p=0.8) underwent radiation therapy and/or hormonal treatment. The mail limit of this study included the small number of patients. CONCLUSIONS: This study represents the secondary, midterm analysis of a previously published trial and 4 years data confirmed our previous findings. In other words, RARP provided better functional results in terms of the recovery of continence and potency; these results are stable during the follow up period.