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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
150
Assisted-robotic radical prostatectomy.
Assisted-robotic radical prostatectomy.
Assisted-robotic radical prostatectomy.
Urology Unit, AOUI Verona
Verona, Italy
RECRUITINGNumber of participants with postoperative complications
Overall postoperative complications (% score \>0) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication
Time frame: Over the 4 days post surgery
Number of participants with moderate to major postoperative complications
Moderate to major complications (% score \>=2) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication
Time frame: Over the 4 days post surgery
Number of participants with major postoperative complications
Major complications (% score \>=3) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication
Time frame: Over the 4 days post surgery
Estimated Blood Loss
Volume
Time frame: Intraoperative
Overall duration of the surgery
Minutes
Time frame: Intraoperative
Anesthesia, Lymphadenectomy, Prostatectomy
Minutes
Time frame: Entrance of patient into operating room until completion of surgery
Number and type of intraoperative complications
Note
Time frame: Intraoperative
Postoperative hospitalization
Days of recovery until the date of release
Time frame: From the surgery day up to 10 days postoperative
Postoperative pain
Numerical Rating Scale (NRS) 0-10 scale for the self-reported rate of pain: zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Time frame: 1-4 days postoperative
Prostate Specific Antigen (PSA)
PSA test
Time frame: 1 month follow-up
Positive Surgical Margin
Rate at histological examination
Time frame: Up to 2 weeks postoperative (during histological analysis)
Lymph nodes resection
Number of lymph nodes removed
Time frame: Intraoperative
Urinary, sexual, and intestinal function assessment
University of California, Los Angeles (UCLA) Prostate Cancer Index (PCI) questionnaire Domains: * Urinary function (5 items) * Urinary bother (1 item) * Sexual function (8 items) * Sexual bother (1 item) * Bowel function (4 items) * Bowel bother (1 item) Response options: 3- to 6-point Likert scales. The higher the score, the better the outcome
Time frame: Preoperative and follow-up (1, 3 and 6 months)
Quality of Life Evaluation
Short Form Health Survey (SF-36) 36 questions (8 domains) for self-reported measure of health. Domain score from 0 to 100: the higher the score, the more favorable the state of health
Time frame: Preoperative and follow-up at 1, 3 and 6 months
Time taken for platform-related technical steps
Set up of operating table, Electric connections, Draping, Undraping, Docking, Undocking, Cleaning: time in minutes
Time frame: From the room setting, through surgical procedure until postoperative room restoration for each of expected 150 surgeries (through study completion: an average of 1 year)
Possible malfunction of the platform
Note
Time frame: Intraoperative
Procedure-related costs
Estimate
Time frame: From surgical procedure to the end of follow-up period (6 months)
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