Research on the Effectiveness and Safety of Remote Control of Domestic Surgical Robot System for Urinary Surgery
Condition: Renal Cell Carcinoma; Adrenal Tumor; Nonfunctioning Kidney
MeSH terms: Carcinoma, Renal Cell; Adrenal Gland Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      One-arm clinical trial was adopted in this study. The surgeon 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
      manipulation into a control signal. After network transmission, the patient side cart (based
      in other cities in Shandong Province) 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. Fifty patients with urinary diseases 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. Fifty patients with
      urinary diseases are planned to enroll in the clinical trial.
    

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 the patients 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,
      represets a new generation of surgical robot systems. In addition to the flexible and
      intelligent characteristics of traditional robots, the robot 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, the domestically produced robot has
      been successfully applied in clinical surgery. 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. 5G technology 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 2020, 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 radical cystectomy on a male patient. The
      5G network (Plan A) was used throughout the operation, with an average total delay of 254ms
      (including an average round-trip delay of 104ms and a packet loss rate of 0%). The operation
      time was about 5 hours, the intraoperative bleeding was about 200ml, and no intraoperative
      complications occurred. The patient recovered smoothly after the operation and was discharged
      on the 18th day. 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 with
      more patients 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 manipulation 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 other cities in Shandong 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 and nephrectomy, were performed by a surgeon from the departments of urology.
      The surgeon in Qingdao performed the dissection and coagulation of the target organs, while
      assistants in other cities 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): telesurgery by domestic robot
Intervention type(s): Device
Intervention description(s): telesurgery of the upper urinary disease by domestic robot
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other