Implementation Of A Telesurgery Program At A Referral Center For Robotic Surgery
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study ID
- NCT07792109
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Robot-Assisted Telesurgery — DEVICERobot-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.
Study Details
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.
Key Dates
- First listed
- Aug 28, 2026
- Start date
- Aug 20, 2026
- Status verified
- Aug 2026
- Primary completion
- Nov 30, 2026
- Completion
- May 30, 2027
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: Patients Undergoing Robotic Surgery With Remote Surgical SupportPatients undergoing robot-assisted telesurgery, with the operating surgeon located at a remote hospital site while the patient undergoes the procedure at the referral center.
Primary Outcome Measure
Conversion Rate from Remote to Local Robotic Surgery (%) [ Time Frame: Intraoperatively ]
Central Contacts
- BERNARDO B ROCCO, MD+393358306522
- Maria Chiara MC Sighinolfi, md,phD+393921329216
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