Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Prostate (COMPAR-P)

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

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 Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: DaVinci RARP; Device: Hugo RARP; Device: Versius RARP

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessandro AA Antonelli; Phone Number: +39 0458127701; Email: alessandro.antonelli@aovr.veneto.it

Study Locations

• Italy
  • Verona, Italy, 37126
    • Recruiting
    • Urology Unit, AOUI Verona
    • Contact: Alessandro AA Antonelli; Phone Number: +39 0458127701; Email: alessandro.antonelli@aovr.veneto.it
    • Contact: Unità di Ricerca Clinica; Phone Number: +39 0458122844; Email: unita.ricerca.clinica@aovr.veneto.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
• Investigators: Principal Investigator: Alessandro AA Antonelli, Azienda Ospedaliera Universitaria Integrata Verona

Publications and helpful links

Helpful Links

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Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative complications; Robotic-assisted surgery; Prostatectomy; Operative outcomes; Multiple surgical platforms
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: COMPAR-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes