COMPAR-P: Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Prostate
Study Details
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:
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DaVinci;
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Hugo;
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Versius.
The questions it aims to answer are:
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Does the estimation of the post-operative complications suggest something?
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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:
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surgery with the daVinci platform;
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surgery with the Hugo platform;
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surgery with the Versius platform.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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:
|
| Experimental: Hugo system Robot-assisted radical prostatectomy is carried out through Hugo platform. |
Device: Hugo RARP
Assisted-robotic radical prostatectomy.
Other Names:
|
| Experimental: Versius system Robot-assisted radical prostatectomy is carried out through Versius platform. |
Device: Versius RARP
Assisted-robotic radical prostatectomy.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- Estimated Blood Loss [Intraoperative]
Volume
- Overall duration of the surgery [Intraoperative]
Minutes
- Anesthesia, Lymphadenectomy, Prostatectomy [Entrance of patient into operating room until completion of surgery]
Minutes
- Number and type of intraoperative complications [Intraoperative]
Note
- Postoperative hospitalization [From the surgery day up to 10 days postoperative]
Days of recovery until the date of release
- 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"
- Prostate Specific Antigen (PSA) [1 month follow-up]
PSA test
- 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
- 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
- Possible malfunction of the platform [Intraoperative]
Note
- Procedure-related costs [From surgical procedure to the end of follow-up period (6 months)]
Estimate
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > 18 and < 90 years;
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Organ-localized prostate cancer with a surgical indication of radical prostatectomy;
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Informed consent provided.
Exclusion Criteria:
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Age < 18 and > 90 years;
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Contraindication to radical prostatectomy procedure;
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Non-organ confined prostate cancer;
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Refusal to participate.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Urology Unit, AOUI Verona | Verona | Italy | 37126 |
Sponsors and Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona
Investigators
- Principal Investigator: Alessandro AA Antonelli, Azienda Ospedaliera Universitaria Integrata Verona
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- COMPAR-P