Thoracic Surgery by SHURUI Single-Port Surgical Robot: A Prospective Single Centre Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- conversion rate
研究概览
简要总结
The introduction of single-port surgical robot has been a transformative breakthrough in the medical field, representing a significant advancement in minimally invasive procedures. One notable innovation is the SHURUI single-port surgical robot (SP), developed by Beijing Surgerii Robotics Company Limited. The SHURUI SP represents a cutting-edge technology in the field. This system features snake-like surgical instruments utilizing "dual continuum mechanism", which enables precise single-port procedures with wide range of motion and high load capacity.
The SHURUI SP has been cleared by the National Medical Products Administration (NMPA) of China for use in urology and gynecology and has completed clinical trials for general surgery and thoracic surgery. It is China's first and the world's second approved single-port surgical robot. Compared to multi-port surgical robots, it can provide patients with less trauma, fewer complications, and faster recovery.
The SHURUI SP has also achieved significant breakthroughs in clinical applications. It conducted the world's first randomized controlled clinical trial on single-port robotic urologic surgery and introduced a series of innovative surgical paradigms. These include the world's first single-port sleeve lobectomy, single-port retroperitoneal adrenalectomy, single-port retroperitoneal partial nephrectomy, single-port distal gastrectomy (Billroth I anastomosis), and single-port total gastrectomy.
Our centre is the first robotic surgical centre in Hong Kong since 2005. Over the years, investigators have established our centre to be one of the leading centre in Hong Kong and the region, with involvement in various new development in thoracic robotic procedures, publications and books, and more recently in robotic endo-lumenal procedures.
In this study, investigators evaluate the early surgical outcome and objective functional outcome of patients undergoing robotic thoracic surgery by SHURUI SP.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 - 75 years;
- •Subjects need to undergo endoscopic surgery and meet one of the following indications for surgical treatment:
- •Lobectomy, segmentectomy wedge resection of lung: Clinically diagnosed resectable early stage non-small cell lung carcinoma; oligometastatic cancer to the lung;
- •Mediastinal mass resection: Clinically diagnosed mediastinal tumour (benign or malignant) that are indicated for resection;
- •Preoperative ASA grade: Grade I-III;
- •Subject voluntarily participates in the clinical trial, and agrees or his/her guardian agrees and signs the informed consent.
排除标准
- •Subjects with a previous history of thoracic surgery or other malignant tumor which, in the judgement of the investigator, make them unsuitable for enrolment;
- •Subjects with severe co-morbidities or organ dysfunction (heart, lung, liver, brain, kidney, etc.) or deemed too weak/ unsuitable for general anesthesia or operation;
- •Non-correctable coagulopathy and severe bleeding tendency；
- •Emergency surgery;
- •Severe obesity with BMI ≥30 kg/m2;
- •Subjects with severe allergic constitution, suspected or confirmed alcohol, drug addiction;
- •Other circumstances in which the investigator considered participation in this clinical trial inappropriate.
结局指标
主要结局
conversion rate
时间窗: 1 year + 1 month follow-up
The feasibility of the Endoscopic Surgical System, SR-ENS-600 for thoracic robotic procedures (Lobectomy, Segmentectomy Wedge resection of lung and Mediastinal Tumour Resection), as measured by the conversion rate
major peri-operative complication rate (Clavein-Dindo grading III or above)
时间窗: 1 year + 1 month follow-up
The safety profile of the Endoscopic Surgical System, SR-ENS-600 for thoracic robotic procedures (Lobectomy, Segmentectomy Wedge resection of lung and Mediastinal Tumour Resection), as measured by the peri-operative complication profile.
次要结局
- Blood transfusion rate(1 year)
- The Surgeon Satisfaction Questionnaire(1 year+ 1 month follow-up)
- Operation time(1 year)
- Estimated intraoperative blood loss (EBL)(1 year)
- Length of hospital stay(1 year + 1 month follow-up)
- Postoperative pain score(1 year + 1 month follow-up)
- Perioperative complication(1 year)
- device defects incidence(1 year)
- readmission rate within 30 days after surgery(1 month follow-up)
- re-operation rate with 30 days after surgery(1 month follow-up)
- Mortality within 30 days after surgery(1 month follow-up)
研究者
Calvin Sze Hang Ng
Professor
Chinese University of Hong Kong