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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
25
Robot-assisted telesurgery performed using the Toumai robotic surgical system. Patients undergo robotic surgery at Fondazione Policlinico Gemelli IRCCS. The surgical procedure is initiated and completed by the local surgical team, while one or more predefined surgical steps are performed remotely by a second console surgeon located at Isola Tiberina Hospital. At any time during the procedure, the local console surgeon can immediately resume control of the robotic system if required.
Unita Operativa Complessa - Urologia - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM, Italy
Unita Operativa Complessa di Ginecologia Oncologica e UOC Carcinoma Ovarico, IRCCS Gemelli
Rome, Roma, Italy
Unita Oprativa Complessa Chirurgia Generale - IRCCS Fondazione Policlinico Gemelli , Roma
Rome, Roma, Italy
Conversion Rate from Remote to Local Robotic Surgery (%)
Rate (%) of conversion from remote robotic surgery to completion of the procedure by the local console surgeon without further remote surgical involvement (due to unintended/urgent/emergency issues)
Time frame: Intraoperatively
Rate of Intraoperative Adverse Events
Occurrence and severity of intraoperative adverse events graded according to the Satava grading system and ICARUS classification.
Time frame: Intraoperatively
Postoperative Complications
Postoperative complications graded according to the Clavien-Dindo classification.
Time frame: Up to 30 post-operative days
Network Latency (msec)
Mean network latency recorded during the entire surgical procedure and during each surgical step.
Time frame: Intraoperatively
Rate of Technical Malfunctions
Number and type of technical malfunctions, including alarms, collisions, and deviations from the planned surgical strategy.
Time frame: Intraoperatively
Length of Hospital Stay (day)
Length of postoperative hospital stay.
Time frame: Time (days) up to hospital discharge
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