PROSPECTIVE RANDOMIZED CONTROLLED TRIAL EVALUATING THE EFFICACY OF INTRAOPERATIVE ARISTA™ AH POLYSACCHARIDE APPLICATION ON THE POSTOPERATIVE BLOOD LOSS IN PATIENTS UNDERGOING ROBOTIC ASSISTED RADICAL PROSTATECTOMY FOR THE TREATMENT OF PROSTATE CANCER
We perform a multicenter randomized controlled prospective study with superiority trial design, in which the polysaccharide ARISTA™ AH hemostat agent is applied to the neurovascular bundle areas after prostate removal, during Robot-assisted radical prostatectomy. We examine if such agent leads to a relevant clinical improvement indicated by higher postoperative hemoglobin levels compared to the control group. As an exploratory co-primary endpoint of interest, we examine erectile function after Robot-assisted radical prostatectomy based on IIEF-5 score between groups 3, 6 and 12 months after Robot-assisted radical prostatectomy
• Age range ≥ 45 to ≥68 yrs
• Biopsy proven prostate cancer treated with robotic-assisted radical prostatectomy
• Intrafascial nerve sparing surgery (unilaterally or bilaterally)
• Preoperative urinary continence
• Group A Preoperative unassisted International Index of Erectile function (IIEF)-5 score range 8-16 (i.e. moderate (8-11) and mild to moderate (12-16))