Comparative Evaluation of New Surgical Robotic Platforms for the Radical Prostatectomy Procedure
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of participants with postoperative complications
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age > 18 and < 90 years;
- •Organ-localized prostate cancer with a surgical indication of radical prostatectomy;
- •Informed consent provided.
排除标准
- •Age < 18 and > 90 years;
- •Contraindication to radical prostatectomy procedure;
- •Non-organ confined prostate cancer;
- •Refusal to participate.
研究组 & 干预措施
DaVinci system
Robot-assisted radical prostatectomy is carried out through daVinci platform.
干预措施: DaVinci RARP (Device)
Hugo system
Robot-assisted radical prostatectomy is carried out through Hugo platform.
干预措施: Hugo RARP (Device)
Versius system
Robot-assisted radical prostatectomy is carried out through Versius platform.
干预措施: Versius RARP (Device)
结局指标
主要结局
Number of participants with postoperative complications
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- Overall duration of the surgery(Intraoperative)
- Number and type of intraoperative complications(Intraoperative)
- 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))
- Anesthesia, Lymphadenectomy, Prostatectomy(Entrance of patient into operating room until completion of surgery)
- Postoperative hospitalization(From the surgery day up to 10 days postoperative)
- Possible malfunction of the platform(Intraoperative)
- Positive Surgical Margin(Up to 2 weeks postoperative (during histological analysis))
- Lymph nodes resection(Intraoperative)
- Urinary, sexual, and intestinal function assessment(Preoperative and follow-up (1, 3 and 6 months))
- Procedure-related costs(From surgical procedure to the end of follow-up period (6 months))
- Estimated Blood Loss(Intraoperative)
- Postoperative pain(1-4 days postoperative)
- Prostate Specific Antigen (PSA)(1 month follow-up)
- Quality of Life Evaluation(Preoperative and follow-up at 1, 3 and 6 months)
研究者
Alessandro Antonelli, MD, Prof
Director of Urology Unit
Azienda Ospedaliera Universitaria Integrata Verona