Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Prostate

Study Overview
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Brief Summary
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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: surgery with the daVinci platform; surgery with the Hugo platform; surgery with the Versius platform.

Official Title
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Comparative Evaluation of New Surgical Robotic Platforms for the Radical Prostatectomy Procedure

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: DaVinci RARP
* Device: Hugo RARP
* Device: Versius RARP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DaVinci system<br>Robot-assisted radical prostatectomy is carried out through daVinci platform. | Device: DaVinci RARP<br>* Assisted-robotic radical prostatectomy.<br>* Other names: DaVinci® Surgical System;|
| Experimental: Hugo system<br>Robot-assisted radical prostatectomy is carried out through Hugo platform. | Device: Hugo RARP<br>* Assisted-robotic radical prostatectomy.<br>* Other names: Hugo™ RAS System;|
| Experimental: Versius system<br>Robot-assisted radical prostatectomy is carried out through Versius platform. | Device: Versius RARP<br>* Assisted-robotic radical prostatectomy.<br>* Other names: Versius® Robotic Surgery System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number 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 | 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 | 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 | Over the 4 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Blood Loss | Volume | Intraoperative | 
| Overall duration of the surgery | Minutes | Intraoperative | 
| Anesthesia, Lymphadenectomy, Prostatectomy | Minutes | Entrance of patient into operating room until completion of surgery | 
| Number and type of intraoperative complications | Note | Intraoperative | 
| Postoperative hospitalization | Days of recovery until the date of release | 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 | 1-4 days postoperative | 
| Prostate Specific Antigen (PSA) | PSA test | 1 month follow-up | 
| Positive Surgical Margin | Rate at histological examination | Up to 2 weeks postoperative (during histological analysis) | 
| Lymph nodes resection | Number of lymph nodes removed | 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 | 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 | 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 | 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 | Intraoperative | 
| Procedure-related costs | Estimate | From surgical procedure to the end of follow-up period (6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic-assisted surgery, Prostatectomy, Multiple surgical platforms, Postoperative complications, Operative outcomes