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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:
The questions it aims to answer are:
Participants will be invited to fill out questionnaires and join one of these three groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DaVinci system | Active Comparator | Robot-assisted radical prostatectomy is carried out through daVinci platform. |
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| Hugo system | Experimental | Robot-assisted radical prostatectomy is carried out through Hugo platform. |
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| Versius system | Experimental | Robot-assisted radical prostatectomy is carried out through Versius platform. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DaVinci RARP | Device | Assisted-robotic radical prostatectomy. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Blood Loss | Volume | Intraoperative |
| Overall duration of the surgery | Minutes | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandro AA Antonelli | Contact | +39 0458127701 | alessandro.antonelli@aovr.veneto.it |
| Name | Affiliation | Role |
|---|---|---|
| Alessandro AA Antonelli | Azienda Ospedaliera Universitaria Integrata Verona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Unit, AOUI Verona | Recruiting | Verona | 37126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41851411 | Derived | Antonelli A, Veccia A, Malandra S, De Marco V, Rizzetto R, Gozzo A, Bianchi A, Brunelli M, Noale M, Cerruto MA, Bertolo R; University of Verona Residency Program in Urology. Six-month outcomes of a three-arm prospective study comparing Da Vinci vs. Hugo RAS vs. versius robotic radical prostatectomy: (the COMPAR-P trial). J Robot Surg. 2026 Mar 19;20(1):361. doi: 10.1007/s11701-026-03260-5. |
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| Related Info | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Hugo RARP | Device | Assisted-robotic radical prostatectomy. |
|
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| Versius RARP | Device | Assisted-robotic radical prostatectomy. |
|
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| 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:
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) |
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| Related Info | View source |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |