Implementation Of A Telesurgery Program At A Referral Center For Robotic Surgery

Implementation Of A Telesurgery Program At A Referral Center For Robotic Surgery: Feasibility And Safety Evaluation - Gemelli TeleSurgery Program (GTSP)

This prospective, single-center pilot cohort study aims to evaluate the feasibility and safety of implementing a robotic telesurgery program in a tertiary academic referral center. Adult patients scheduled for elective robotic procedures, like radical prostatectomy or colectomy . Surgical procedures will be performed using the Toumai robotic surgical system. During predefined operative steps, a remote console surgeon located at Gemelli Isola Hospital will perform selected surgical tasks, while the primary console surgeon, the patient, and the entire operating room team remain at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The local surgeon can immediately resume control of the robotic system whenever required. First objective is to assess the feasibility and safety of telesurgery by evaluating the rate of conversion from remote to local robotic surgery. Other objectives include assessment of network performance, technical reliability, perioperative outcomes, and user and patient satisfaction.

Telesurgery is an emerging application of robotic-assisted surgery that enables surgeons to perform selected operative tasks remotely through advanced robotic systems and secure telecommunication technologies. Recent advances in robotic platforms, high-speed network infrastructures, and low-latency connectivity have renewed interest in the clinical implementation of telesurgery. Nevertheless, its adoption in routine clinical practice remains limited because further evidence regarding technical feasibility, safety, organizational requirements, and reproducibility is needed.

Consecutive adult patients eligible for robot-assisted procedures will be enrolled over a three-month recruitment period.

All procedures will be performed at Fondazione Policlinico Universitario Agostino Gemelli IRCCS using the Toumai robotic surgical platform. The patient, bedside surgical team, and primary console surgeon will remain at the Gemelli Hospital throughout the procedure. During predefined surgical phases, a second console surgeon located at Gemelli Isola Hospital will remotely perform selected operative steps. A dedicated network infrastructure with redundant dark-fiber connections, encrypted communication, and predefined latency thresholds has been implemented to ensure secure and reliable data transmission. Whenever considered necessary because of technical issues or surgical judgment, the local console surgeon can immediately resume direct control of the robotic system according to predefined safety protocols.

The primary endpoint is the conversion rate from remote telesurgical control to local robotic surgery during the telesurgical phases of the operation. Secondary endpoints include assessment of technical performance, network latency and reliability, intraoperative and postoperative outcomes, device-related malfunctions, and user and patient satisfaction. The study is intended to generate clinical and organizational evidence supporting the safe implementation of robotic telesurgery in routine surgical practice.

Inclusion Criteria:

• Age ≥18 years.
• American Society of Anesthesiologists (ASA) physical status I-II.
• No significant comorbidities according to the Charlson Comorbidity Index.
• No history of major abdominal surgery.
• Scheduled for elective robot-assisted surgery.
• Able to understand the study procedures and provide written informed consent.

Exclusion Criteria:

• Severe comorbidities that may interfere with study participation or surgical safety.
• Severe bleeding or coagulation disorders, or ongoing treatments that significantly affect coagulation.
• Inability to understand the study procedures or provide informed consent.
• Unwillingness or inability to comply with the study protocol.