The Application of Sentire Surgical System Plus Patient Side Single Arm in Robotic Colorectal Surgery: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Conversion rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •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
排除标准
- •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)
研究组 & 干预措施
Robotic surgery using the Sentire Surgical System Plus Patient Side Single Arm
Robotic surgery using the Sentire Surgical System Plus Patient Side Single Arm
干预措施: Robotic surgery using the Sentire Surgical System Plus Patient Side Single Arm (Procedure)
结局指标
主要结局
Conversion rate
时间窗: Up to 1 month
The definition of a conversion for this study is an emergent or unplanned change in the treatment plan to conventional laparoscopic or open surgery.
Perioperative complications
时间窗: Up to 1 month
Perioperative complications including intraoperative complications and all complications occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification. Complications of Clavien-Dindo grade III (those requiring surgical, endoscopic, or radiologic intervention) or above are regarded as major complications.
次要结局
- Length of hospital stay(Up to 1 month)
- Operative time(Perioperative)
- Operative blood loss(Perioperative)
- Pain scores on visual analog scale(Up to 1 month)
- Analgesic requirement(Up to 1 month)
- Completeness of resection(Up to 1 month)
- Resection margin positivity for malignancy(Up to 1 month)
- Number of lymph nodes harvested(Up to 1 month)
研究者
Simon S. M. Ng
Wei Lun Professor of Surgery
Chinese University of Hong Kong
