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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
DaVinci RARP
Hugo RARP
Versius RARP
Sponsored by
Azienda Ospedaliera Universitaria Integrata Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Cancer focused on measuring Robotic-assisted surgery, Prostatectomy, Multiple surgical platforms, Postoperative complications, Operative outcomes

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Urology Unit, AOUI VeronaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

DaVinci system

Hugo system

Versius system

Arm Description

Robot-assisted radical prostatectomy is carried out through daVinci platform.

Robot-assisted radical prostatectomy is carried out through Hugo platform.

Robot-assisted radical prostatectomy is carried out through Versius platform.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Estimated Blood Loss
Volume
Overall duration of the surgery
Minutes
Anesthesia, Lymphadenectomy, Prostatectomy
Minutes
Number and type of intraoperative complications
Note
Postoperative hospitalization
Days of recovery until the date of release
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"
Prostate Specific Antigen (PSA)
PSA test
Positive Surgical Margin
Rate at histological examination
Lymph nodes resection
Number of lymph nodes removed
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
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 taken for platform-related technical steps
Set up of operating table, Electric connections, Draping, Undraping, Docking, Undocking, Cleaning: time in minutes
Possible malfunction of the platform
Note
Procedure-related costs
Estimate

Full Information

First Posted
February 13, 2023
Last Updated
April 11, 2023
Sponsor
Azienda Ospedaliera Universitaria Integrata Verona
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1. Study Identification

Unique Protocol Identification Number
NCT05766163
Brief Title
Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Prostate
Acronym
COMPAR-P
Official Title
Comparative Evaluation of New Surgical Robotic Platforms for the Radical Prostatectomy Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Universitaria Integrata Verona

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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: surgery with the daVinci platform; surgery with the Hugo platform; surgery with the Versius platform.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Robotic-assisted surgery, Prostatectomy, Multiple surgical platforms, Postoperative complications, Operative outcomes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DaVinci system
Arm Type
Active Comparator
Arm Description
Robot-assisted radical prostatectomy is carried out through daVinci platform.
Arm Title
Hugo system
Arm Type
Experimental
Arm Description
Robot-assisted radical prostatectomy is carried out through Hugo platform.
Arm Title
Versius system
Arm Type
Experimental
Arm Description
Robot-assisted radical prostatectomy is carried out through Versius platform.
Intervention Type
Device
Intervention Name(s)
DaVinci RARP
Other Intervention Name(s)
DaVinci® Surgical System
Intervention Description
Assisted-robotic radical prostatectomy.
Intervention Type
Device
Intervention Name(s)
Hugo RARP
Other Intervention Name(s)
Hugo™ RAS System
Intervention Description
Assisted-robotic radical prostatectomy.
Intervention Type
Device
Intervention Name(s)
Versius RARP
Other Intervention Name(s)
Versius® Robotic Surgery System
Intervention Description
Assisted-robotic radical prostatectomy.
Primary Outcome Measure Information:
Title
Number of participants with postoperative complications
Description
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
Title
Number of participants with moderate to major postoperative complications
Description
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
Title
Number of participants with major postoperative complications
Description
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
Secondary Outcome Measure Information:
Title
Estimated Blood Loss
Description
Volume
Time Frame
Intraoperative
Title
Overall duration of the surgery
Description
Minutes
Time Frame
Intraoperative
Title
Anesthesia, Lymphadenectomy, Prostatectomy
Description
Minutes
Time Frame
Entrance of patient into operating room until completion of surgery
Title
Number and type of intraoperative complications
Description
Note
Time Frame
Intraoperative
Title
Postoperative hospitalization
Description
Days of recovery until the date of release
Time Frame
From the surgery day up to 10 days postoperative
Title
Postoperative pain
Description
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
Title
Prostate Specific Antigen (PSA)
Description
PSA test
Time Frame
1 month follow-up
Title
Positive Surgical Margin
Description
Rate at histological examination
Time Frame
Up to 2 weeks postoperative (during histological analysis)
Title
Lymph nodes resection
Description
Number of lymph nodes removed
Time Frame
Intraoperative
Title
Urinary, sexual, and intestinal function assessment
Description
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)
Title
Quality of Life Evaluation
Description
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
Title
Time taken for platform-related technical steps
Description
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)
Title
Possible malfunction of the platform
Description
Note
Time Frame
Intraoperative
Title
Procedure-related costs
Description
Estimate
Time Frame
From surgical procedure to the end of follow-up period (6 months)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro AA Antonelli
Phone
+39 0458127701
Email
alessandro.antonelli@aovr.veneto.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro AA Antonelli
Organizational Affiliation
Azienda Ospedaliera Universitaria Integrata Verona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology Unit, AOUI Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro AA Antonelli
Phone
+39 0458127701
Email
alessandro.antonelli@aovr.veneto.it
First Name & Middle Initial & Last Name & Degree
Unità di Ricerca Clinica
Phone
+39 0458122844
Email
unita.ricerca.clinica@aovr.veneto.it

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/35156838/
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/32169362/
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/35047788/
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/29442240/
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/33559802/
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/16846677/
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/21427584/
Description
Related Info

Learn more about this trial

Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Prostate

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