Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Prostate

Prostate Cancer Clinical Trial

— COMPAR-P  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05766163
• Other study ID #: COMPAR-P
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2023
• Est. completion date: September 2024

Study information

• Verified date: April 2023
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: Alessandro AA Antonelli
• Phone: +39 0458127701
• Email: alessandro.antonelli[@]aovr.veneto.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• DaVinci RARP
Assisted-robotic radical prostatectomy.
• Hugo RARP
Assisted-robotic radical prostatectomy.
• Versius RARP
Assisted-robotic radical prostatectomy.

Locations

Country	Name	City	State
Italy	Urology Unit, AOUI Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

Outcome

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

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