Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robot-Assisted Telesurgery | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients Undergoing Robotic Surgery With Remote Surgical Support
- description
- Patients undergoing robot-assisted telesurgery, with the operating surgeon located at a remote hospital site while the patient undergoes the procedure at the referral center.
- interventionNames
- Device: Robot-Assisted Telesurgery
Primary outcomes (1)
- measure
- Conversion Rate from Remote to Local Robotic Surgery (%)
- timeFrame
- Intraoperatively
- description
- 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 (5)
- measure
- Rate of Intraoperative Adverse Events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (14)
- BACKGROUNDReitano G, Tumminello A, Ghaffar U, Saggionetto G, Taverna A, Mangiacavallo F, Ahmed ME, Basourakos SP, Carletti F, Minardi D, Iafrate M, Morlacco A, Betto G, Karnes RJ, Moro FD, Zattoni F, Novara G. Perioperative, Oncological, and Functional Outcomes of New Multiport Robotic Platforms in Urology: A Systematic Review and Meta-analysis. Eur Urol Open Sci. 2025 Mar 3;74:44-70. doi: 10.1016/j.euros.2025.02.003. eCollection 2025 Apr. PMID 40115596
- BACKGROUNDPokhrel G, Zheng H, Tao J, Cui J, Fan Y, Li Z, Dong B, Yu S, Zhang X. Assessing the Feasibility and Safety of the Toumai(R) Robotic System in Urologic Surgery: Initial Experience. J Endourol. 2024 Jun;38(6):552-558. doi: 10.1089/end.2024.0028. PMID 38468506
- BACKGROUNDPokhrel G, Zheng H, Tao J, Fan Y, Liu Y, Dong B, Yu S, Zhang X. Evaluation of the Toumai robotic system in partial nephrectomy and key system features. Sci Rep. 2025 Apr 16;15(1):13046. doi: 10.1038/s41598-025-97124-x. PMID 40240465
- BACKGROUNDRocco B, Patel V, Covas Moschovas M, Gaia G, Sighinolfi MC. Pre-clinical evaluation of telesurgery with the Toumai microport: the standpoint from multiplatform users. Minerva Urol Nephrol. 2024 Dec;76(6):671-673. doi: 10.23736/S2724-6051.24.06091-9. No abstract available. PMID 39831852
- BACKGROUNDPatel V, Collins JW, Marescaux J, Dohler M, Saikali S, Dasgupta P, Reddy S, Gamal A, Patel E, Rogers T, Siddiqui A, Breda A, Mottrie A, Hassan A, Hung A, Secord A, Rocco B, Pugh C, Sundaram C, Sighinolfi MC, Ellison EC, Davila EP, Wilson E, Balkhy H, Kaouk J, Liang C, Kavoussi LR, Roche M, Martino M, Anvari M, Sylla P, Coelho RF, Thomas R, Clayman R, Leveillee R, Estape R, Goldberg R, Madder R, Horgan S, Magnuson JS, Nathan S, Ross S, Costello A, Xu Z, Chauhan S, Redan J, Satava R, Miles B, Sachdeva AK, Moschovas MC. International multispecialty consensus statement and expert opinion of best practices in telesurgery. J Robot Surg. 2025 Apr 1;19(1):135. doi: 10.1007/s11701-025-02298-1. No abstract available. PMID 40167848