Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Prostate

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Device: DaVinci RARP; Device: Hugo RARP; Device: Versius RARP

• Registration Number: NCT05766163
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-03-10
• Study First Posted: 2023-03-13
• Study Start: 2023-03-14
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12
• Primary Completion: 2024-03
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DaVinci system	DaVinci RARP	Robot-assisted radical prostatectomy is carried out through daVinci platform.
Hugo system	Hugo RARP	Robot-assisted radical prostatectomy is carried out through Hugo platform.
Versius system	Versius RARP	Robot-assisted radical prostatectomy is carried out through Versius platform.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Prostate Specific Antigen (PSA)	1 month follow-up	PSA test
Overall duration of the surgery	Intraoperative	Minutes
Number and type of intraoperative complications	Intraoperative	Note
Positive Surgical Margin	Up to 2 weeks postoperative (during histological analysis)	Rate at histological examination
Lymph nodes resection	Intraoperative	Number of lymph nodes removed
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
Procedure-related costs	From surgical procedure to the end of follow-up period (6 months)	Estimate
Estimated Blood Loss	Intraoperative	Volume
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"
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
Anesthesia, Lymphadenectomy, Prostatectomy	Entrance of patient into operating room until completion of surgery	Minutes
Postoperative hospitalization	From the surgery day up to 10 days postoperative	Days of recovery until the date of release
Possible malfunction of the platform	Intraoperative	Note

Trial Locations

Locations (1)

Urology Unit, AOUI Verona; 🇮🇹 Verona, Italy