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Not Yet Recruiting NCT07792109

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

Conditions: Prostate Cancer, Colorectal Cancer

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 25
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Location: Unita Operativa Complessa - Urologia - Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma RM

Summary

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07792109). StuddyBuddy aggregates publicly available trial information.