Prostate Cancer
Conditions
Keywords
Robotic-assisted surgery, Prostatectomy, Multiple surgical platforms, Postoperative complications, Operative outcomes
Brief 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.
Interventions
DEVICEDaVinci RARP
Assisted-robotic radical prostatectomy.
DEVICEHugo RARP
Assisted-robotic radical prostatectomy.
DEVICEVersius RARP
Assisted-robotic radical prostatectomy.
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with postoperative complications | Over the 4 days post surgery | 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 |
| Number of participants with moderate to major postoperative complications | Over the 4 days post surgery | 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 |
| Number of participants with major postoperative complications | Over the 4 days post surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and type of intraoperative complications | Intraoperative | Note |
| Postoperative hospitalization | From the surgery day up to 10 days postoperative | Days of recovery until the date of release |
| Postoperative pain | 1-4 days postoperative | 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 |
| Prostate Specific Antigen (PSA) | 1 month follow-up | PSA test |
| Positive Surgical Margin | Up to 2 weeks postoperative (during histological analysis) | Rate at histological examination |
| Estimated Blood Loss | Intraoperative | Volume |
| Urinary, sexual, and intestinal function assessment | Preoperative and follow-up (1, 3 and 6 months) | 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 |
| Quality of Life Evaluation | Preoperative and follow-up at 1, 3 and 6 months | 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 taken for platform-related technical steps | 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) | Set up of operating table, Electric connections, Draping, Undraping, Docking, Undocking, Cleaning: time in minutes |
| Possible malfunction of the platform | Intraoperative | Note |
| Procedure-related costs | From surgical procedure to the end of follow-up period (6 months) | Estimate |
| Lymph nodes resection | Intraoperative | Number of lymph nodes removed |
| Overall duration of the surgery | Intraoperative | Minutes |
| Anesthesia, Lymphadenectomy, Prostatectomy | Entrance of patient into operating room until completion of surgery | Minutes |
Countries
Italy
Contacts
Primary ContactAlessandro AA Antonelli
Outcome results
None listed