Actively Recruiting
Evaluating the Effect of Intraoperative ARISTA13 AH Polysaccharide on Blood Loss in Patients Undergoing Robotic-Assisted Radical Prostatectomy for Prostate Cancer
Led by St. Antonius Hospital Gronau · Updated on 2026-05-29
362
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
S
St. Antonius Hospital Gronau
Lead Sponsor
B
Becton, Dickinson and Company
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
EFFICACY OF INTRAOPERATIVE ARISTA POLYSACCHARIDE APPLICATION ON THE POSTOPERATIVE BLOOD LOSS IN PATIENTS UNDERGOING RARP FOR THE TREATMENT OF PROSTATE CANCER
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 45 and 68 years
- Biopsy-proven prostate cancer treated with robotic-assisted radical prostatectomy
- Undergoing intrafascial nerve-sparing surgery (unilateral or bilateral)
- Preoperative urinary continence
- Preoperative unassisted International Index of Erectile Function (IIEF-5) score between 8 and 16
You will not qualify if you...
- Severe intellectual limitations preventing understanding of the study
- High-risk prostate cancer (PSA 20 ng/ml, Gleason score 8, or suspected T4)
- Suspected bone or visceral metastases on preoperative imaging
- Prior local prostate therapy, chemotherapy, or colon/rectal surgery
- History of pelvic trauma requiring surgery
- Depression or severe psychological/neurological diseases
- Peyronie's disease
- Polyneuropathy
- IPSS score over 19 and quality of life score over 3
- Bilateral secondary resection of the neurovascular bundle
- Contraindications for phosphodiesterase type 5 inhibitors
- Any endocrine disorder except diabetes
- Preservation of accessory pudendal arteries if identified
- Use of monopolar thermal application in nerve-sparing and bleeding control areas
- Surgical revision within 7 days after surgery (Clavien Dindo 3b)
- Anastomotic rupture within 30 days after surgery identified by cystogram
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and hospital stay until initial recovery
Participants undergo robotic-assisted radical prostatectomy with or without the intraoperative application of 5g of ARISTA™ AH polysaccharide to control bleeding during surgery.
1 surgical procedure and immediate post-operative hospital care
Duration - Up to 12 months after surgery
Participants are monitored after surgery to assess postoperative blood loss and recovery, including evaluations of urinary continence and erectile function.
Visits at 3, 6, and 12 months post-surgery
Trial Site Locations
Total: 3 locations
1
Martini Klinik am UKE GmbH
Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246
Actively Recruiting
2
St. Antonius-Hospital Gronau GmbH, Klinik für Urologie, Urologische Onkologie und Roboter-assistierte Chirurgie
Gronau, North Rhine-Westphalia, Germany, 48599
Actively Recruiting
3
Klinik und Poliklinik für Urologie des Universitätsklinikums Leipzig
Leipzig, Saxony, Germany, 04103
Actively Recruiting
Research Team
S
Sami-Ramzi Leyh-Bannurah, PD. Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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