Efficacy and Safety of Clinical Telesurgery Using Chinese Independently Developed Surgical Robot System
Condition: Renal Cell Carcinoma; Bladder Cancer; Adrenal Tumor
MeSH terms: Carcinoma, Renal Cell; Adrenal Gland Neoplasms
Study type: Interventional

Summary: 
      One-arm clinical trial was adopted in this study. The surgeons performed remote urological
      surgery for patients through domestically produced "MicroHand" surgical robot system
      (Shandong Weigao Co., Ltd). The "MicroHand" surgical robot system consists of two physically
      separated subsystems named the "surgeon console" and "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 (one for the endoscopic camera and the other two for surgical
      instruments). The surgeon console (based in Qingdao) takes the surgeon's input and translates
      it into a control signal. After network transmission, the patient side cart (based in Anshun)
      translates the control signal into actual instrument manipulation. The 3D images captured by
      the endoscopic camera were simultaneously sent back to the screen of the surgeon console as
      visual feedback. Data between the surgeon console and the patient side cart were transmitted
      through a 5G network. The safety and effectiveness of the robotic system in remote clinical
      diagnosis and treatment were verified by the main judgment criterion and secondary judgment
      criterion. Six patients are planned to enroll in the clinical trial.

      Main judgment criterion:

      The robot-assisted telesurgery did not transfer to other types of surgery, such as open
      surgery or normal robot-assisted surgery.

      Secondary judgment criterion:

      operative time, blood loss, postoperative pain, preoperative adjusting time and
      hospitalization time.

      Patient enrollment:

      This trial aims to explore the safety and effectiveness of the domestically produced robotic
      system in remote clinical diagnosis and treatment through 5G network. Six patients are
      planned to enroll in the clinical trial, including 2 patients with adrenal tumor, 2 patients
      with bladder cancer and 2 patients with renal cell carcinoma.
    

Detailed description: 
      Objective： This clinical trial aims to evaluate the efficacy and safety of telesurgery for
      patients with tumors of the urinary system using Chinese independently developed "MicroHand"
      Surgical Robot System through 5G network.

      Content： One-arm clinical trial was adopted in this study. The product was domestically
      produced "MicroHand" surgical robot system (Shandong Weigao Co., Ltd). Before entering the
      clinical study, the patients were fully informed and the written informed consent were
      signed. According to the inclusion criteria and exclusion criteria, the researchers will
      conduct a detailed screening to determine whether they are suitable for the clinical study.
      Telesurgery would be conducted for patients who met the inclusion criteria using "MicroHand"
      surgical robot system. Data between the surgeon console and the patient side cart were
      transmitted through a 5G network. The safety and efficacy of the robotic system in remote
      clinical diagnosis and treatment were verified according to the main judgment criterion and
      secondary judgment criterion.

      Background： With the combination of robotic and network communication technology, telesurgery
      has become a reality. On the one hand, telesurgery can conserve and optimize medical
      resources, providing high-quality medical services to unbalanced areas, such as rural areas,
      stricken areas and battlefields. On the other hand, telesurgery can reduce the time spent by
      patients waiting for treatment and thus prevent diseases from worsening.

      The unbalanced distribution of medical resources has been a prominent problem in China. In
      addition, the vast territory and relatively lower medical distribution ratio per capita make
      it difficult for patients to receive timely and high-quality treatment, especially those in
      remote and underdeveloped areas. Therefore, telesurgery is more significant in China. In
      recent years, surgical robot systems and network communication technology have experienced
      breakthroughs. The operation systems of the Da Vinci robot in America, the REVO-I robot in
      South Korea and the ALF-X robot in Italy are more flexible and intelligent, performing well
      in surgical procedures. The "Micro Hand S" system robot, independently developed in China,
      represents a new generation of surgical robot systems. In addition to the flexible and
      intelligent characteristics of traditional robots, it has a series of advantages, such as a
      clear interface, light weight, low cost in terms of use and maintenance, and strong equipment
      compatibility. After preliminary experiments, it has been successfully applied in clinical
      surgery6. Meanwhile, in the field of network communication, the emerging 5G mobile
      communication technology (the 5th generation of wireless systems, 5G technology for short) is
      the latest generation of cellular mobile communication technology. It is also an extension of
      4G (LTE-A or WiMax), 3G (UMTS or LTE) and 2G (GSM) technology. 5G technology has a high data
      rate, low latency, high throughput, equipment connection on a large scale, low cost and low
      energy consumption. The emergence of 5G technology offers more opportunities for the
      prevalence of telesurgery.

      In September 2019, our research group carried out the first 5G remote telesurgery using the
      "Micro Hand S" system robot and a 5G network between Qingdao, Shandong Province, and Xixiu,
      Guizhou Province, in September 2019 in China (the network communication distance was nearly
      3000 km). Specifically, the investigators conducted four ultra-remote laparoscopic surgeries,
      including left nephrectomy, partial hepatectomy, cholecystectomy and cystectomy in a swine
      model under the 5G network using a domestically produced "Micro Hand S" surgical robot. the
      investigators accomplished four laparoscopic telesurgeries successfully, with an average
      network delay of 264 ms (including a round-trip transporting delay of 114 ms and a 1.20% data
      package loss ratio). Moreover, the total blood loss was 25 ml and no complications occurred
      during the procedures. The investigators demonstrated that ultra-remote laparoscopic
      telesurgery can be performed safely and smoothly under the 5G network using domestically
      produced equipment. On such basis, our research group planned to carry out this clinical
      trial to evaluate the efficacy and safety of telesurgery for patients with tumors of the
      urinary system using Chinese independently developed "MicroHand" Surgical Robot System
      through 5G network.

      Introduction of the "MicroHand" surgical robot： The "MicroHand" surgical robot system
      consists of two physically separated subsystems named the "surgeon console" and "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 (one for the endoscopic camera and the other
      two for surgical instruments). The surgeon console (based in Qingdao) takes the surgeon's
      input and translates it into a control signal. After network transmission, the patient side
      cart (based in Anshun) translates the control signal into actual instrument manipulation. The
      3D images captured by the endoscopic camera were simultaneously sent back to the screen of
      the surgeon console as visual feedback.

      Steps of the procedure：

      ① The surgeon console was placed in Qingdao, Shangdong Province, while the patient side cart
      was placed in Anshun, Guizhou Province.

      ② Connections between the surgeon console and the patient side cart were established through
      a public 5G wireless network. Special 5G customer premise equipment (CPE) was used as a
      signal repeater station and amplifier. Upload and download speed will be tested as network
      bandwidth.

      ③ After general anesthesia, the supine position was maintained, the surgical area was
      disinfected, and pneumoperitoneum was established from the left side of the umbilicus by
      using a Veress needle. Then, trocars were inserted, and slave arms were delivered. Slave arm
      A was equipped with robotic grasp pliers, and Slave arm C was equipped with an ultrasonic
      scalpel (bipolar pliers or electrocautery). Robot-assisted telesurgeries, including
      adrenalectomy, cystectomy and nephrectomy, were performed by surgeons from the departments of
      urology. Surgeons in Qingdao performed the dissection and coagulation of the target organs,
      while assistants in Anshun performed exposure of structures and clip application. Trocar
      placement and position of the patients were also adjusted in each telesurgery by the
      assistants if necessary. After completion of the dissection, the target organs were removed
      by the assistant bedside. Then the pneumoperitoneum was exsufflated and the incisions were
      closed. Intraoperative network latencies and vital signs were monitored constantly. The
      master-slave manipulation consistency was assessed subjectively. The operative time, blood
      loss and complications were recorded.
    

Intervention name(s): adrenalectomy for adrenal adenoma
Intervention type(s): Procedure
Intervention description(s): adrenalectomy， cystectomy and nephrectomy
Other intervention name(s): cystectomy for muscle-invasive bladder cancer; nephrectomy for patients with renal cell carcinoma.
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment