Study of ARISTA4 AH Polysaccharide Use During Robotic Prostate Surgery to Reduce Blood Loss and Improve Erectile Function

What this Trial Is About

Researchers are conducting a multicenter, randomized controlled trial to evaluate the effect of applying the polysaccharide agent ARISTA13 AH during robotic-assisted radical prostatectomy RARP for prostate cancer. The study aims to determine if this agent reduces postoperative blood loss by measuring hemoglobin levels after surgery. Additionally, the trial explores the impact on erectile function using the IIEF-5 score at 3, 6, and 12 months post-surgery. Participants will be randomly assigned to one of two groups one group will receive a 5g application of ARISTA13 AH to the prostate bed and neurovascular bundles during and at the end of surgery to control bleeding, while the other group will not receive this agent in these areas. No other hemostatic agents will be used in the treated areas. The surgery involves nerve-sparing techniques either unilaterally or bilaterally. Throughout the study, participants will be monitored for changes in hemoglobin levels from before surgery to 5-6 days afterward, as well as their erectile function at specified time points up to one year. Safety evaluations include monitoring for surgical complications and the integrity of the anastomosis. The total duration of participation includes the surgery and follow-up visits up to 12 months after RARP.

EFFICACY OF INTRAOPERATIVE ARISTA POLYSACCHARIDE APPLICATION ON THE POSTOPERATIVE BLOOD LOSS IN PATIENTS UNDERGOING RARP FOR THE TREATMENT OF PROSTATE CANCER