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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

No phase Interventional Prostate Cancer (Adenocarcinoma) Blood Loss, Postoperative Erectile Function

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Arm A - Application of 5g of ARISTA™ AH.
Who it may be relevant to
Registry conditions: Prostate Cancer (Adenocarcinoma), Blood Loss, Postoperative, Erectile Function. Basic parameters: 45 years — 68 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

  • 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

Primary outcome measures

  • postoperative blood loss [Time frame: 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 [Time frame: 3, 6 and 12 months after RARP]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Germany · 3 centers
  • Martini Klinik am UKE GmbH — Hamburg
  • St. Antonius-Hospital Gronau GmbH, Klinik für Urologie, Urologische Onkologie und Roboter- — Gronau
  • Klinik und Poliklinik für Urologie des Universitätsklinikums Leipzig — Leipzig

Identifiers

NCT: NCT06822036 · 2023-601-f-S

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗