RecruitingNot ApplicableNCT06822036

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

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


Sponsor

St. Antonius Hospital Gronau

Enrollment

362 participants

Start Date

Jan 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: MALEMin Age: 45 YearsMax Age: 68 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether applying a topical starch-based powder (Arista) during robotic-assisted prostate removal surgery reduces blood loss after the operation. It focuses on men with moderate erectile dysfunction who undergo nerve-sparing surgery. **You may be eligible if...** - You are between 45 and 68 years old - You have biopsy-confirmed prostate cancer being treated with robotic-assisted radical prostatectomy - You are having nerve-sparing surgery (unilateral or bilateral) - You were continent (no leaking urine) before surgery - Your erectile function score falls in the moderate to mild-to-moderate range (IIEF-5 score 8-16) **You may NOT be eligible if...** - You have high-risk prostate cancer (PSA 20 or above, Gleason score 8 or higher, or suspected spread) - You have suspected bone or organ metastases - You received hormone therapy before surgery - You have cognitive limitations preventing understanding of the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREArm A - Application of 5g of ARISTA™ AH

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


Locations(3)

Martini Klinik am UKE GmbH

Hamburg, Free and Hanseatic City of Hamburg, Germany

St. Antonius-Hospital Gronau GmbH, Klinik für Urologie, Urologische Onkologie und Roboter-assistierte Chirurgie

Gronau, North Rhine-Westphalia, Germany

Klinik und Poliklinik für Urologie des Universitätsklinikums Leipzig

Leipzig, Saxony, Germany

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NCT06822036


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