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| Name | Class |
|---|---|
| West China Hospital Tibet Hospital, Sichuan University | UNKNOWN |
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Hepatic echinococcosis (HE) is a serious endemic parasitic disease in high-altitude regions like Xizang. Radical hepatectomy is the primary curative treatment, but expert resources are often concentrated in large medical centers. This prospective, single-arm study aims to evaluate the feasibility and safety of performing remote robotic hepatectomy using the Chinese Toumai™ robotic system over a 5G network. Ten patients in West China Hospital Tibet Hospital, Sichuan University (Lhasa, 3650m altitude) will undergo surgery performed by expert surgeons at West China Hospital (Chengdu). The primary focus is the surgical success rate and perioperative safety.
This study aims to evaluate the feasibility and safety of performing radical hepatectomy for hepatic echinococcosis in a high-altitude region (Lhasa, Xizang, 3650m altitude) utilizing the domestic Toumai™ robotic surgical system via 5G network communication.
Hepatic echinococcosis is a significant endemic parasitic disease in high-altitude areas. While radical resection remains the definitive treatment, a disparity in the distribution of expert surgical resources poses challenges to patient access. This prospective study investigates the following:
Technical Feasibility: To validate whether the 5G network performance, specifically regarding latency and image resolution in a high-altitude and long-distance transmission environment, meets the clinical requirements for real-time robotic surgery.
By establishing a closed-loop surgical connection between the center (Chengdu) and the remote site (Lhasa), the team will monitor real-time tele-interaction stability. This study includes robust contingency protocols for network instability or mechanical failure to ensure patient safety, providing clinical evidence for the standardization of remote hepatobiliary surgery in underserved regions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5G-based Telerobotic Hepatectomy | Experimental | Participants in this study will undergo radical hepatectomy for hepatic echinococcosis performed via the Toumai™ robotic surgical system. The procedure is executed remotely by expert surgeons at the master console in the hub hospital (Chengdu) who control the robotic arms installed at the remote site hospital (Lhasa). The intervention is facilitated by a dedicated 5G network slicing solution designed to provide ultra-low latency (<50ms) and high-fidelity real-time endoscopic visualization. The surgery is conducted under the support of the SurgSmart AI auxiliary system, with a local bedside surgical team present at the remote site to provide intraoperative assistance and emergency backup, ensuring patient safety throughout the tele-robotic procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5G-based Telerobotic Hepatectomy | Procedure | Participants will undergo a radical hepatectomy for hepatic echinococcosis using the domestic Toumai™ robotic surgical system. The procedure is performed via a tele-robotic approach, where the lead surgeon operates from a remote console at the hub hospital (Chengdu) to control robotic arms positioned at the remote site (Lhasa). The intervention is integrated with a dedicated 5G network slicing solution designed to maintain ultra-low latency (<50ms) and high-fidelity 4K 3D endoscopic video transmission, ensuring real-time synchronization between the surgeon's input and mechanical response. The procedure also incorporates the SurgSmart AI auxiliary system for real-time anatomical identification, and is supported by a local bedside surgical team at the remote site who provide intraoperative assistance and emergency backup, maintaining a standardized clinical workflow for complex tele-robotic liver resections. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success Rate of 5G-based Telerobotic Hepatectomy | Technical success is defined as the successful completion of the pre-planned radical resection of hepatic echinococcosis using the Toumai™ robotic surgical system, strictly adhering to the following criteria: (1) no intraoperative conversion to open surgery due to system failure or technical complications; (2) no intraoperative damage to critical vascular or biliary structures attributed to robotic system latency or mechanical malfunction; (3) no requirement for emergency manual intervention by the bedside team to rectify system-related issues; and (4) the successful completion of the target procedure within the standardized operative time framework. This metric serves as the primary indicator for evaluating the operational feasibility and safety of the 5G telerobotic model. | From the start of the robotic procedure until the completion of the surgery, assessed up to 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Efficiency -Operative Time | Total time elapsed from the first skin incision to the completion of skin closure, measured in minutes. | From skin incision to skin closure, assessed up to 24 hours. |
| Intraoperative Safety-Estimated Intraoperative Blood Loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingyun Xie, M.D., Ph.D. | Contact | +8618608070908 | xieqingyun@stu.scu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Chengdu | Sichuan / 四川 | 614000 | China |
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be shared.
Beginning 6 months and ending 36 months following article publication.
Data will be available to researchers who provide a methodologically sound proposal. Proposals should be directed to the corresponding author [xieqingyun@stu.scu.edu.cn]. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D004444 | Echinococcosis, Hepatic |
| ID | Term |
|---|---|
| D004443 | Echinococcosis |
| D002590 | Cestode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
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The intervention utilizes the Toumai™ multi-port robotic system integrated with a dedicated 5G network slicing solution to ensure ultra-low latency (<50ms). Surgeons at the master console in Chengdu perform real-time procedures via a hand-eye coordination interface, controlling robotic arms at the remote site in Lhasa. The model incorporates the SurgSmart AI system for intraoperative anatomical identification and a bidirectional audio-video link for hub-remote collaboration. A robust safety protocol is implemented, featuring an emergency lock mechanism and a trained local bedside team capable of taking over the procedure within 5 seconds in the event of network instability or mechanical failure.
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Total volume of blood lost during the surgical procedure, calculated by measuring the volume in the suction canisters and the weight increase of surgical gauzes (1 gram = 1 milliliter). |
| From the start of surgery to the completion of the procedure, assessed up to 24 hours. |
| Intraoperative Safety-Intraoperative Blood Transfusion Rate | The percentage of participants who required an allogeneic blood transfusion during the surgical procedure. | From the start of surgery to the completion of the procedure, assessed up to 24 hours. |
| Rate of Conversion to Open or Laparoscopic Surgery | The percentage of cases where the telerobotic procedure could not be completed as planned and required conversion to traditional open surgery or conventional laparoscopy due to technical or safety reasons. | From the start of the robotic procedure until the completion of the surgery, assessed up to 24 hours. |
| Postoperative Clinical Recovery-Length of Postoperative Hospital Stay | The total number of days from the date of surgery to the date of hospital discharge. | From date of surgery until the date of hospital discharge, assessed up to 60 days. |
| Postoperative Clinical Recovery-Time to First Postoperative Ambulation | The time interval from the end of the surgical procedure to the moment the patient first stands and walks independently or with minimal assistance, measured in hours. | From the end of surgery until the first documented ambulation, assessed up to 10 days. |
| Incidence of Postoperative Complications (Clavien-Dindo Classification) | The percentage of participants experiencing one or more postoperative complications within 30 days, graded according to the Clavien-Dindo classification system (ranging from Grade I to Grade V). | From the end of surgery up to 30 days post-operation. |
| Tele-Robotic System Performance-Incidence of Robotic Device Defects | The number of technical incidents related to the Toumai™ robotic system, including both mechanical malfunctions and software failures, that occur during the procedure. | From the start of the robotic procedure until the completion of the surgery, assessed up to 24 hours. |
| Tele-Robotic System Communication Quality-Average 5G Network Round-Trip Latency | The mean duration of data transmission delay between the hub (Chengdu) and the remote site (Lhasa), measured in milliseconds (ms) using real-time network monitoring tools. | Continuously during the surgical procedure (approximately 3 to 6 hours). |
| Surgeon-Perceived Image Quality and Transmission Stability Score | A subjective evaluation performed by the remote surgeon using a Likert scale (ranging from 1 = Poor to 5 = Excellent) to assess the 3D endoscopic image resolution and the stability of the video feed during the procedure. | Assessed once immediately after the completion of the surgery. |
| Total NASA Task Load Index (NASA-TLX) Score | The overall cognitive and physical workload of the remote surgeon assessed using the NASA Task Load Index (NASA-TLX) questionnaire. Six subscales (Mental Demand, Physical Demand, Temporal Demand, Performance, Effort, and Frustration) are rated on a scale of 0-100 and then aggregated into a single weighted average score (ranging from 0 to 100), where higher scores indicate a higher workload. | Within 24 hours after the completion of each surgery. |
| Textbook Outcome in Liver Surgery (TOLS) | TOLS is a composite measure representing the optimal surgical result. It is defined as a case meeting all the following criteria: no intraoperative grade III or higher complications, R0 resection margin (no tumor cells at the margin), no prolonged hospital stay, no 30-day readmission, and no 30-day mortality. This provides a holistic view of the quality of the 5G-based telerobotic radical hepatectomy. | Up to 30 days post-operation. |
| D007239 |
| Infections |
| D008109 | Liver Diseases, Parasitic |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |