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RECRUITING

NCT06822036

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

Sponsor: St. Antonius Hospital Gronau

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

MALE

Age Range

45 Years - 68 Years

Study Type

INTERVENTIONAL

Enrollment

362

Start Date

2025-01-16

Completion Date

2027-01-30

Last Updated

2026-05-29

Healthy Volunteers

Conditions

Prostate Cancer (Adenocarcinoma)Blood Loss, Postoperative Erectile Function

Interventions

PROCEDURE

Arm 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

Inclusion Criteria: * 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)) Exclusion Criteria: * Severe intellectual limitations preventing to fully understand the study concept and its content * High risk prostate cancer (PSA ≥ 20 ng/ml or biopsy Gleason-Score ≥ 8 or suspected T4) * Suspected bone or visceral metastases at preoperative imaging Neoadjuvant androgen deprivation therapy * Any prior local therapy of the prostate (including subvesical deobstruction or radiation therapy) * Any prior chemotherapy or colon/rectal surgery * Any prior pelvic trauma that required surgical intervention * Depression or other psychological or neurological disease (dementia, schizophrenia, bipolar disorder etc.) * Peyronie's disease * Polyneuropathia * IPSS Score \>19 and QoL \>3 * Bilateral secondary (complete or partial) resection of the neurovascular bundle * No contraindications for phosphodiesterase type 5 inhibitor intake (i.e. suited for most penile rehabilitation regimes) * Any endocrine function disorder (not including diabetes) SURGICAL AND PERIOPERATIVE EXLUSION CRITERIA: * Accessory pudendal arteries (APA) preservation, if an APA is identified * For a) nerve sparing and b) controlling bleeding in the area of the prostate bed and neurovascular bundles after prostate removal, no monopolar thermal application are allowed but suturing and clip application is allowed. For secondary resection of the neurovascular bundle and controlling bleeding, mono- or bipolar thermal application, clip application and suturing is allowed. * No surgical revision within 7d after RARP (Clavien Dindo classified complication ≥3b) * No definitive anastomotic partial or complete rupture (identified via cystogram within 30d after RARP)

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