Comparison Between HUGO RAS Robotic Platform and Da Vinci Robotic Platform
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Radical prostatectomy, Partial nephrectomy.
- Кому может быть актуально
- Состояния в реестре: Prostate Cancer (Adenocarcinoma), Renal Cancer. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
HUGO RAS Robotic Platform for Radical Prostatectomy and Partial Nephrectomy: Comparison with the Da Vinci Robotic Platform
Обзор
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).
Подробное описание
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.
Вмешательства
- Процедура Radical prostatectomy
Radical prostatectomy performed using the Da Vinci Xi and the HUGO RAS platform - Процедура Partial nephrectomy
partial nephrectomy (PN) using either the Da Vinci Xi platform or the HUGO™ RAS platform
Первичные конечные точки
- Equivalence of the HUGO RAS platform compared to the Da Vinci Xi robot in terms of perioperative complications [Срок оценки: 90 days]
Вторичные конечные точки (12)
- Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Ergonomics for the primary and secondary operators [Срок оценки: during surgery]
- Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Operative times [Срок оценки: during surgery]
- Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Instrument conflicts or malfunctions [Срок оценки: during surgery]
- Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Intraoperative blood loss [Срок оценки: during surgery]
- Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Length of hospital stay. [Срок оценки: up to 4 days]
- Oncologic outcomes of PR or PN surgery - Rate of positive surgical margins [Срок оценки: 90 days after surgery]
- Oncologic outcomes of PR or PN surgery : Survival time free of biochemical recurrence of disease. [Срок оценки: 5 years]
- Oncologic outcomes of PR or PN surgery : - Metastasis-free survival time [Срок оценки: 5 years]
- Oncologic outcomes of PR or PN surgery : Overall survival [Срок оценки: 5 years]
- Oncologic outcomes of PR or PN surgery : Cancer-specific survival [Срок оценки: 5 years]
- functional outcomes of PR or PN surgery: - International Index of Erectile Function (IIEF-5) score of recovery of sexual function [Срок оценки: 5 years]
- functional outcomes of PR or PN surgery: - Number of pads used [Срок оценки: 5 years]
Критерии участия
Критерии включения
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.
Критерии исключения
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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Италия · 1 центр
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Идентификаторы
NCT: NCT06844513 · URO ROBOT 2023