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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
362
Perioperative application of 5g of ARISTA™ AH to the prostate bed and neurovascular bundles during and at the end of the surgery to control bleeding and oozing in accordance with labelled directions; no other hemostyptic agent in aforementioned area
Martini Klinik am UKE GmbH
Hamburg, Free and Hanseatic City of Hamburg, Germany
RECRUITINGSt. Antonius-Hospital Gronau GmbH, Klinik für Urologie, Urologische Onkologie und Roboter-assistierte Chirurgie
Gronau, North Rhine-Westphalia, Germany
RECRUITINGKlinik und Poliklinik für Urologie des Universitätsklinikums Leipzig
Leipzig, Saxony, Germany
RECRUITINGpostoperative blood loss
In theory, the experimental treatment should not have any improvement in ΔHgB between day 5-6 day and preoperative hemoglobin levels
Time frame: improvement in ΔHgB between day 5-6 day and preoperative hemoglobin levels
comparison between groups A and B concerning the unassisted IIEF-5 score between groups
A difference of the median IIEF-5 score of minimally four points between groups is considered as clinically relevant. Based on these considerations, 84 patients per treatment arm are required (including an assumed dropout rate of 33% or less). As it is possible that the effect of nerve stabilization of ARISTA™ AH may differ according to the preoperative potency status, two groups of patients will be analyzed:
Time frame: 3, 6 and 12 months after RARP
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