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Trial Title:
Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Prostate
NCT ID:
NCT05766163
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Robotic-assisted surgery
Prostatectomy
Multiple surgical platforms
Postoperative complications
Operative outcomes
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
DaVinci RARP
Description:
Assisted-robotic radical prostatectomy.
Arm group label:
DaVinci system
Other name:
DaVinci® Surgical System
Intervention type:
Device
Intervention name:
Hugo RARP
Description:
Assisted-robotic radical prostatectomy.
Arm group label:
Hugo system
Other name:
Hugo™ RAS System
Intervention type:
Device
Intervention name:
Versius RARP
Description:
Assisted-robotic radical prostatectomy.
Arm group label:
Versius system
Other name:
Versius® Robotic Surgery System
Summary:
The object of this exploratory clinical trial is to evaluate post-operative complications
in a population that underwent Robotic Assisted Radical Prostatectomy (RARP) made with
multiple platforms:
- DaVinci;
- Hugo;
- Versius.
The questions it aims to answer are:
- Does the estimation of the post-operative complications suggest something?
- Are differences (intra-operative, post-operative, oncological, functional,
technical, and economic) among the three intervention approaches observable?
Participants will be invited to fill out questionnaires and join one of these three
groups:
1. surgery with the daVinci platform;
2. surgery with the Hugo platform;
3. surgery with the Versius platform.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age > 18 and < 90 years;
- Organ-localized prostate cancer with a surgical indication of radical prostatectomy;
- Informed consent provided.
Exclusion Criteria:
- Age < 18 and > 90 years;
- Contraindication to radical prostatectomy procedure;
- Non-organ confined prostate cancer;
- Refusal to participate.
Gender:
Male
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Urology Unit, AOUI Verona
Address:
City:
Verona
Zip:
37126
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Alessandro AA Antonelli
Phone:
+39 0458127701
Email:
alessandro.antonelli@aovr.veneto.it
Contact backup:
Last name:
Unità di Ricerca Clinica
Phone:
+39 0458122844
Email:
unita.ricerca.clinica@aovr.veneto.it
Start date:
March 14, 2023
Completion date:
September 2024
Lead sponsor:
Agency:
Azienda Ospedaliera Universitaria Integrata Verona
Agency class:
Other
Source:
Azienda Ospedaliera Universitaria Integrata Verona
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05766163
https://pubmed.ncbi.nlm.nih.gov/35156838/
https://pubmed.ncbi.nlm.nih.gov/32169362/
https://pubmed.ncbi.nlm.nih.gov/35047788/
https://pubmed.ncbi.nlm.nih.gov/29442240/
https://pubmed.ncbi.nlm.nih.gov/33559802/
https://pubmed.ncbi.nlm.nih.gov/16846677/
https://pubmed.ncbi.nlm.nih.gov/21427584/
