EFFICACY OF INTRAOPERATIVE ARISTA POLYSACCHARIDE APPLICATION ON THE POSTOPERATIVE BLOOD LOSS IN P… (NCT06822036) | Clinical Trial Compass
RecruitingNot Applicable
EFFICACY OF INTRAOPERATIVE ARISTA POLYSACCHARIDE APPLICATION ON THE POSTOPERATIVE BLOOD LOSS IN PATIENTS UNDERGOING RARP FOR THE TREATMENT OF PROSTATE CANCER
Germany362 participantsStarted 2025-01-16
Plain-language 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
Who can participate
Age range
45 Years – 68 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
postoperative blood loss
Timeframe: improvement in ΔHgB between day 5-6 day and preoperative hemoglobin levels
2
comparison between groups A and B concerning the unassisted IIEF-5 score between groups