Clinical Trial Protocol of Primary Study on Efficacy and Safety of Telesurgery for Patients With Tumors of the Urinary System Using Chinese Independently Developed "MicroHand" Surgical Robot System

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.