The Efficacy and Safety of Chinese Domestic Surgical Robot System in Urological Telesurgery

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.

Sex

All

Minimum age

18 Years

Maximum age

80 Years

Inclusion Criteria:

* Patients aged 18-80 years.
* BMI was 18-30 kg/m2.
* 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.

Exclusion Criteria:

* 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

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