The Application of Sentire Surgical System Plus Patient Side Single Arm in Robotic Colorectal Surgery

Официальное название

The Application of Sentire Surgical System Plus Patient Side Single Arm in Robotic Colorectal Surgery: A Prospective Study

Обзор

Robotic assisted surgery has been performed for more than two decades with good success and safety profile. However, there was only one dominating robotic surgical system available in the past which led to high cost for robotic surgery. Recently, a new robotic surgical system (Sentire Robotic Surgical System) was introduced by researchers of The Chinese University of Hong Kong (CUHK). This new robotic surgical system aims to achieve similar outcomes and standards of robotic surgery performed using the dominating system but with a significantly lower cost. The technologic innovation and development of this new robotic system is made by the Cornerstone Robotics Limited, which is based in Hong Kong. In a pilot clinical study conducted at Prince of Wales Hospital involving 55 patients, the Sentire Surgical System C1000 had demonstrated high success rate with minimal complications in patients who underwent robotic colorectal surgery. Recently, a new component of the system - the Patient Side Single Arm, is developed. It is an independent robotic arm designed for compatibility with the Sentire Surgical System, creating the hybrid surgical system known as the C1000 Ultra. The new component may enhance port placement flexibility, minimize arm collisions with the patient or operating table, and optimize docking for seamless integration into the operating room. The Patient Side Single Arm was proven by a preclinical study using cadaveric models to be safe and effective. The investigators would therefore like to conduct a prospective clinical study to evaluate the efficacy and safety of Sentire Surgical System Plus the Patient Side Single Arm in robotic colorectal surgery. The investigators believe that the results of this study will provide data to support its use for wide range of colorectal procedures with minimal access trauma, for the benefit of patients. This system will also lead to a wider range of clinical applications for minimally invasive surgery with a cost-effective model.

Вмешательства

• Процедура Robotic surgery using the Sentire Surgical System Plus Patient Side Single Arm
  Robotic surgery using the Sentire Surgical System Plus Patient Side Single Arm

Первичные конечные точки

• Conversion rate [Срок оценки: Up to 1 month]
• Perioperative complications [Срок оценки: Up to 1 month]

Вторичные конечные точки (8)

• Operative time [Срок оценки: Perioperative]
• Operative blood loss [Срок оценки: Perioperative]
• Pain scores on visual analog scale [Срок оценки: Up to 1 month]
• Analgesic requirement [Срок оценки: Up to 1 month]
• Length of hospital stay [Срок оценки: Up to 1 month]
• Completeness of resection [Срок оценки: Up to 1 month]
• Resection margin positivity for malignancy [Срок оценки: Up to 1 month]
• Number of lymph nodes harvested [Срок оценки: Up to 1 month]

Критерии участия

Критерии включения

• Adenocarcinoma or large adenoma (not amenable to endoscopic removal) located at the colorectum (from the cecum to the anal verge) amenable to minimally invasive surgery
• Body mass index <35 kg/m2
• Willingness to participate as demonstrated by giving informed consent

Критерии исключения

• T4 tumor
• Recurrent tumor
• Extensive previous abdominal surgery precluding minimally invasive surgery
• Contraindication to general anesthesia
• Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
• Untreated active infection
• Noncorrectable coagulopathy
• Presence of another malignancy or distant metastasis
• Emergency surgery
• Vulnerable population (e.g., mentally disabled, pregnancy)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Prince of Wales Hospital, The Chinese University of Hong Kong — Гонконг

Идентификаторы

NCT: NCT07453706 · CREC 2025.712

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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