Clinical trial NCT05766163: Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Prostate
Official title: Comparative Evaluation of New Surgical Robotic Platforms for the Radical Prostatectomy Procedure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Robotic-assisted surgery
Prostatectomy
Multiple surgical platforms
Postoperative complications
Operative outcomes
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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:

1. surgery with the daVinci platform;
2. surgery with the Hugo platform;
3. surgery with the Versius platform.


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.

Primary outcomes:
measure: Number of participants with postoperative complications
timeFrame: Over the 4 days post surgery
measure: Number of participants with moderate to major postoperative complications
timeFrame: Over the 4 days post surgery
measure: Number of participants with major postoperative complications
timeFrame: Over the 4 days post surgery
Secondary outcomes:
measure: Estimated Blood Loss
timeFrame: Intraoperative
measure: Overall duration of the surgery
timeFrame: Intraoperative
measure: Anesthesia, Lymphadenectomy, Prostatectomy
timeFrame: Entrance of patient into operating room until completion of surgery
measure: Number and type of intraoperative complications
timeFrame: Intraoperative
measure: Postoperative hospitalization
timeFrame: From the surgery day up to 10 days postoperative
measure: Postoperative pain
timeFrame: 1-4 days postoperative
measure: Prostate Specific Antigen (PSA)
timeFrame: 1 month follow-up
measure: Positive Surgical Margin
timeFrame: Up to 2 weeks postoperative (during histological analysis)
measure: Lymph nodes resection
timeFrame: Intraoperative
measure: Urinary, sexual, and intestinal function assessment
timeFrame: Preoperative and follow-up (1, 3 and 6 months)
measure: Quality of Life Evaluation
timeFrame: Preoperative and follow-up at 1, 3 and 6 months
measure: Time taken for platform-related technical steps
timeFrame: 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)
measure: Possible malfunction of the platform
timeFrame: Intraoperative
measure: Procedure-related costs
timeFrame: From surgical procedure to the end of follow-up period (6 months)
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Urology Unit, AOUI Verona
Study officials:
affiliation: Azienda Ospedaliera Universitaria Integrata Verona
name: Alessandro AA Antonelli
role: PRINCIPAL_INVESTIGATOR
References: