The Efficacy and Safety of Chinese Domestic Surgical Robot System in Urological Telesurgery, an Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- success rate of the telesurgery
研究概览
简要总结
A single-arm clinical trial was designed in this study. The surgeon will perform urological telesurgery for patients using Chinese domestically produced "MicroHand S" surgical robot system. The "MicroHand S" surgical robot system consists of two physically separated subsystems named the "surgeon console" and the "patient side cart". The surgeon console includes a stereo image viewer, two master manipulators, a control panel and several foot pedals. The patient side cart includes a passive arm that can slide in the up-down direction and be adjusted forward and backward, a swivel head that can rotate around the vertical axis, and three slave arms. In addition, surgical instruments and sterile bags are the essential accessories for the "patient side cart". The principle of the telesurgery is as follows: the surgeon console takes the surgeon's input and translates manipulation into a control signal. After network transmission, the signals will be received by the patient side cart and will be used to control the slave robot to manipulate the instruments to perform the operation within the patient's cavity. The 3D images captured by the endoscopic camera will be simultaneously sent back to the screen of the surgeon console as visual feedback. Data between the surgeon console and the patient side cart will be transmitted through a 5G network or other advanced network networking scheme. The surgeon remotely manipulates the slave arms and performs surgeries for patients in remote areas. The safety and efficacy of the robot system in remote clinical treatment will be verified by the primary and the secondary evaluation criteria. One hundred patients with urological diseases will be enrolled in the clinical trial.
Primary evaluation criterion:
The success rate of the surgery. Surgery success is defined as that all surgeries are performed remotely and safely without transfering to other types of surgery, such as open surgery or normal robot-assisted surgery.
Secondary evaluation criteria:
Operative time, blood loss, postoperative pain, preoperative adjusting time, hospitalization time, average network latency, task load, peer recognition, anxiety index.
Patient enrollment:
This experiment aims to investigate the safety and effectiveness of the domestic robot system in clinical urological surgery under the current network networking scheme. It is planned that 100 patients with urinary system diseases will participate in the clinical trial.
详细描述
Objective: This clinical trial aims to evaluate the efficacy and safety of telesurgery for patients with urological tumors using Chinese independently developed "MicroHand S" Surgical Robot System under the current advanced network networking scheme.
Content: A single-arm clinical trial was designed in this study. The product is domestically produced "MicroHand S" surgical robot system (Shandong Weigao Surgical Robot Co., Ltd, China). The patients will be fully informed and the written informed consent will be signed before the clinical study, According to the inclusion criteria and exclusion criteria, the researchers will conduct a detailed screening to determine whether the patients are suitable for the clinical study. Telesurgery will be conducted for patients who meet the inclusion criteria using the "MicroHand S" surgical robot system. Data between the "surgeon console" and the "patient side cart" will be transmitted through the current advanced network networking scheme. Fifty telesurgeries has been performed for patients with renal tumor, adrenal tumor, or nonfunctional kidney disease in 2021. All the surgeries were completed successfully, which made an positive social influence. In order to explore other indications, 100 subjects will be enrolled in the clinical trial. All diseases will be included if it is applicable to be treated by telesurgery, such as, adrenal tumor, renal tumor, renal cyst, duplex kidney, renal calculi, ureteral calculi, ureteropelvic junction obstruction (UPJO), nonfunctional kidney, renal pelvis tumor, ureteral tumor, bladder cancer, prostate cancer, pelvic tumor, penile cancer, etc. The safety and efficacy of remote clinical treatment using the domestic robot system will be verified according to the primary evaluation criterion, secondary evaluation criteria, and safety evaluation index.
Network connection plan: Two network connection plans were designed in advance to transmit data between the two sites (the master and the slave) in telesurgery. Plan A: Both signals (the control signals and the video signals) were transmitted in a VPN encryption mode under 5G wireless network or other advanced network networking scheme. Plan B: Both signals were transmitted through the dedicated line. When 5G network or other advanced network networking scheme was unstable and the surgery was affected, Plan A could be switched to Plan B to ensure the success of telesurgery. The two sites were also connected through a video conference system for real time communication and coordination.
Primary evaluation criterion: The primary evaluation criterion is the success rate of the surgery.
Secondary evaluation criteria: Secondary evaluation criteria include operative time, intraoperative blood loss, assembly time, postoperative pain, hospital stay, time to first flatus, average network latency, task load index, patient acceptance of telesurgery, peer surgeon acceptance of telesurgery, patient anxiety index, surgeon anxiety index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-80 years.
- •BMI was 18-30 kg/m
- •The American Society of Anesthesiologists (ASA) classification was I, II, or III.
- •Patients with adrenal tumor that need radical or partial adrenalectomy (nonfunctioning adenoma, < 5cm in diameter).
- •Patients with renal cell carcinoma that need radical nephrectomy or partial nephrectomy.
- •Patients with renal cyst that need decompression surgery.
- •Patients with duplex kidney that need radical nephroureterectomy.
- •Patients with renal calculi that need intrasinusal pyelolithotomy.
- •Patients with ureteral calculi that need ureterolithotomy.
- •Patients with ureteropelvic junction obstruction (UPJO) that need pyeloplasty.
- •Patients with urological diseases (such as, pelvic segment disease of the ureter, or duplex kidney) that need ureteral reimplantation.
- •Patients with nonfunctioning kidney that need radical nephrectomy.
- •Patients with renal pelvis carcinoma that need radical nephroureterectomy.
- •Patients with ureteral tumor that need radical nephroureterectomy.
- •Patients with bladder cancer that need radical or partial cystectomy.
- •Patients with prostate cancer that need radical prostectomy.
- •Patients with penile cancer that need Ilioinguinal lymph node dissection.
排除标准
- •Women in pregnancy or lactation
- •A history of epilepsy or mental illness
- •Previous relevant operation history (all abdominal operations that may increase difficulty in telesurgery)
- •Patients with a severe cardiovascular and cerebrovascular disease with New York Heart Association (NYHA) classification III-IV and pulmonary insufficiency who cannot tolerate the operation
- •Liver cirrhosis, kidney failure and other severe liver and kidney dysfunction (ALT and AST exceeded 3 times of the upper limit of normal value, Cr exceeded 1.5 times of the upper limit of normal value)
- •Patients with general hemorrhagic diseases and coagulation dysfunction (prothrombin activity, PTA <25%)
- •Patients with active hepatitis and AIDS
- •Patients with uncorrected diabetes (random blood glucose, RBG >11.1 mmol/L) and hypertension (≥160/100 mmHg)
- •Patients with severe allergic constitution and suspected or confirmed alcohol, medicine or drug addiction
- •Patients with abdominal infection, peritonitis or diaphragmatic hernia
- •Patients with severe systemic infection or metastatic disease
- •Patients who are unable to voluntarily participate and sign informed consent
- •Other circumstances under which the investigator considers it is inappropriate to participate in this clinical trial
结局指标
主要结局
success rate of the telesurgery
时间窗: after the study is completed, up to 2 years.
The success of the telesurgery is the robot-assisted telesurgery without transfering to other types of surgery, such as open surgery or normal robot-assisted surgery. The number of the success divided by the total number is the success rate.
次要结局
- Assembly time(from the time the robot starts to the time the trocar is connected to the robot arm during each procedure, all data will be collected within 4 months)
- Patient anxiety index(one day before or after the telesurgery, all data will be collected within 4 months)
- Average network latency(during the whole procedure in each telesurgery, all data will be collected within 1 months)
- Operative time(after each procedure is completed, all data will be collected within 4 months)
- Intraoperative blood loss(after each procedure is completed, all data will be collected within 4 months)
- Postoperative pain(at 24±2 hours after each procedure is completed, all data will be collected within 4 months)
- Hospital stay(from admission to discharge for each patients, all data will be collected within 4 months)
- Patient acceptance(one day before the telesurgery, all data will be collected within 4 months)
- Peer surgeon acceptance(one day before the telesurgery, all data will be collected within 4 months)
- Task load(after each procedure is completed, all data will be collected within 4 months)
- Surgeon anxiety index(one day before or after the telesurgery, all data will be collected within 4 months)
研究者
Haitao Niu, MD
Professor Haitao Niu (the department of Urology)
The Affiliated Hospital of Qingdao University