HUGO RAS Robotic Platform for Radical Prostatectomy and Partial Nephrectomy: Comparison with the Da Vinci Robotic Platform
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Equivalence of the HUGO RAS platform compared to the Da Vinci Xi robot in terms of perioperative complications
研究概览
简要总结
The study is designed as a single-center, prospective, interventional, non-pharmacological, randomized, open-label, controlled trial with parallel groups. It targets patients with prostate cancer or kidney cancer who are candidates for robot-assisted surgical treatment, specifically radical prostatectomy (RP) or partial nephrectomy (PN).
详细描述
The study is designed as a single-center, prospective, interventional, non-pharmacological, randomized, open-label, controlled trial with parallel groups. It targets patients with prostate cancer or kidney cancer who are candidates for robot-assisted surgical treatment, specifically radical prostatectomy (RP) or partial nephrectomy (PN). The study is divided into a patient enrolment and robot-assisted treatment phase, followed by a phase of oncological and functional follow-up. Once enrolled, patients will be randomized to undergo treatment using either the Da Vinci Xi platform (Intuitive Surgical) or the HUGO™ RAS platform (Medtronic) according to block randomization.
Patients with prostate cancer (Group A), enrolled according to inclusion criteria, will be randomized to undergo RP treatment with the Da Vinci Xi platform (control group) or RP treatment with the HUGO™ RAS platform (study group).
Patients with kidney cancer (Group B), enrolled according to inclusion criteria, will be randomized to undergo PN treatment with the Da Vinci Xi platform or PN treatment with the HUGO™ RAS platform.
If the surgical, oncological, and functional outcomes observed following radical prostatectomy and partial nephrectomy performed with the HUGO RAS platform prove to be equivalent to those obtained with the Da Vinci Xi platform, it should lead to a progressive increase in the use of the HUGO RAS platform, resulting in a reduction in the overall costs associated with robotic urological surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Prostate Cancer (Group A)
- •Age ≥ 18 years.
- •Life expectancy greater than 10 years.
- •Diagnosis of prostate cancer following prostate needle biopsy.
- •Clinical stage cT1-T3b, N0-1 disease.
- •Positive anesthetic fitness assessment for robot-assisted radical prostatectomy.
- •Provision of informed consent for the study.
- •Patients with Kidney Cancer (Group B)
- •Age ≥ 18 years.
- •Radiological diagnosis of organ-confined kidney cancer at clinical stage T1a or T1b.
- •Underwent CT and/or MRI of the abdomen with contrast medium.
- •Positive anesthetic fitness assessment for robot-assisted partial nephrectomy.
- •Provision of informed consent for the study.
排除标准
- •Patients with Prostate Cancer (Group A)
- •Expression of a preference for radical treatment other than surgery (e.g., external radiotherapy).
- •Metastatic prostate cancer (M1).
- •Other conditions deemed by healthcare professionals to contraindicate inclusion in the study.
- •Patients with Kidney Cancer (Group B)
- •Indication for radical nephrectomy.
- •Metastatic kidney cancer (M1).
- •Other conditions deemed by healthcare professionals to contraindicate inclusion in the study.
结局指标
主要结局
Equivalence of the HUGO RAS platform compared to the Da Vinci Xi robot in terms of perioperative complications
时间窗: 90 days
To demonstrate the equivalence of the HUGO RAS platform compared to the Da Vinci Xi robot in terms of perioperative complications observed within 90 days post-surgery. This evaluation will be conducted separately for: Patients undergoing radical prostatectomy (RP). Patients undergoing partial nephrectomy (PN). perioperative complication rate of grade greater than or equal to Clavien-Dindo IIIa within 90 days after surgery will be calculated.
次要结局
- functional outcomes of PR or PN surgery: - International Index of Erectile Function (IIEF-5) score of recovery of sexual function(5 years)
- Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Ergonomics for the primary and secondary operators(during surgery)
- Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Instrument conflicts or malfunctions(during surgery)
- Oncologic outcomes of PR or PN surgery - Rate of positive surgical margins(90 days after surgery)
- Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Operative times(during surgery)
- Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Length of hospital stay.(up to 4 days)
- Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Intraoperative blood loss(during surgery)
- functional outcomes of PR or PN surgery: - Number of pads used(5 years)
- Oncologic outcomes of PR or PN surgery : Survival time free of biochemical recurrence of disease.(5 years)
- Oncologic outcomes of PR or PN surgery : Overall survival(5 years)
- Oncologic outcomes of PR or PN surgery : Cancer-specific survival(5 years)
- Oncologic outcomes of PR or PN surgery : - Metastasis-free survival time(5 years)