Status:
RECRUITING
EFFICACY of INTRAOPERATIVE ARISTA POLYSACCHARIDE APPLICATION on the POSTOPERATIVE BLOOD LOSS in PATIENTS UNDERGOING RARP for the TREATMENT of PROSTATE CANCER
Lead Sponsor:
St. Antonius Hospital Gronau
Collaborating Sponsors:
Becton, Dickinson and Company
University of Leipzig
Conditions:
Prostate Cancer (Adenocarcinoma)
Blood Loss, Postoperative
Eligibility:
MALE
45-68 years
Phase:
NA
Brief Summary
Background and aim of the study: Radical prostatectomy (RP) is one of the most commonly used treatment options for localized prostate cancer (PCa). Blood loss and deterioration of erectile function is...
Eligibility Criteria
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)
Key Trial Info
Start Date :
January 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2027
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT06822036
Start Date
January 16 2025
End Date
January 30 2027
Last Update
February 17 2025
Active Locations (3)
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1
Martini Klinik am UKE GmbH
Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246
2
St. Antonius-Hospital Gronau GmbH, Klinik für Urologie, Urologische Onkologie und Roboter-assistierte Chirurgie
Gronau, North Rhine-Westphalia, Germany, 48599
3
Klinik und Poliklinik für Urologie des Universitätsklinikums Leipzig
Leipzig, Saxony, Germany, 04103