Blood Loss, Postoperative, Erectile Function, Prostate Cancer (Adenocarcinoma)
Conditions
Keywords
prostate cancer, blood loss, potency rates, ARISTA™ AH
Brief 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
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
Sponsors
St. Antonius Hospital Gronau
Becton, Dickinson and Company
University of Leipzig
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
45 Years to 68 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative blood loss | improvement in ΔHgB between day 5-6 day and preoperative hemoglobin levels | In theory, the experimental treatment should not have any 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 | 3, 6 and 12 months after RARP | 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: |
Countries
Germany
Contacts
CONTACTSami-Ramzi Leyh-Bannurah, PD. Dr.
PRINCIPAL_INVESTIGATORSami-Ramzi Leyh-Bannurah, PD
Klinik für Urologie, Urologische Onkologie und Roboter-assistierte Chirurgie
Outcome results
None listed