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NCT Number: NCT07792109

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unita Operativa Complessa - Urologia - Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, RM, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robot-Assisted Telesurgery

Device

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.

Primary outcomes

  1. Conversion Rate from Remote to Local Robotic Surgery (%)

    Time frame: Intraoperatively

    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)

Secondary outcomes

  1. Rate of Intraoperative Adverse Events

    Time frame: Intraoperatively

    Occurrence and severity of intraoperative adverse events graded according to the Satava grading system and ICARUS classification.

  2. Postoperative Complications

    Time frame: Up to 30 post-operative days

    Postoperative complications graded according to the Clavien-Dindo classification.

  3. Network Latency (msec)

    Time frame: Intraoperatively

    Mean network latency recorded during the entire surgical procedure and during each surgical step.

  4. Rate of Technical Malfunctions

    Time frame: Intraoperatively

    Number and type of technical malfunctions, including alarms, collisions, and deviations from the planned surgical strategy.

  5. Length of Hospital Stay (day)

    Time frame: Time (days) up to hospital discharge

    Length of postoperative hospital stay.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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Registry information

Official study title

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

Acronym: GTSP

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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