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

NCT07792109 | Not Yet Recruiting

• 1 other identifier: 7727
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Prostate Cancer; Colorectal Cancer

Keywords

Robotic Surgery; Remote Surgery; Prostatectomy; Colectomy; Prostate Cancer; Colorectal Cancer; Feasibility

Outcome Measures

Primary Outcomes (1)

• 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)

  Intraoperatively

Secondary Outcomes (5)

• Rate of Intraoperative Adverse Events

  Intraoperatively

• Postoperative Complications

  Up to 30 post-operative days

• Network Latency (msec)

  Intraoperatively

• Rate of Technical Malfunctions

  Intraoperatively

• Length of Hospital Stay (day)

  Time (days) up to hospital discharge

Study Arms (1)

Patients Undergoing Robotic Surgery With Remote Surgical Support

EXPERIMENTAL

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.

Device: Robot-Assisted Telesurgery

Interventions

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.

Patients Undergoing Robotic Surgery With Remote Surgical Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (3)

Unita Operativa Complessa - Urologia - Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, 00168, Italy

Location

Unita Operativa Complessa di Ginecologia Oncologica e UOC Carcinoma Ovarico, IRCCS Gemelli

Rome, Roma, 00168, Italy

Location

Unita Oprativa Complessa Chirurgia Generale - IRCCS Fondazione Policlinico Gemelli , Roma

Rome, Roma, 00168, Italy

Location

Related Publications (14)

• Reitano 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 BACKGROUND

• Pokhrel 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 BACKGROUND

• Pokhrel 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 BACKGROUND

• Rocco 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 BACKGROUND

• Patel 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 BACKGROUND

• Wu S, Wu N, Wang Y, Jing R, Wu Y, Yi S. 5G remote robotic-assisted transcervical thyroidectomy: the first case report in the world. BMC Surg. 2025 Apr 25;25(1):182. doi: 10.1186/s12893-025-02927-4.

  PMID: 40281540 BACKGROUND

• Ferreira SV, Sugai MH, Nascimento GC, Souza AC Netto, Cabrini GC, Rodrigues FM, D'Avila CLR, Souza GF, Zerati RV, Zerati M Filho. Feasibility and Initial Outcomes of Telesurgery in Urology: a Systematic Review of the Literature. Int Braz J Urol. 2025 May-Jun;51(3):e20240494. doi: 10.1590/S1677-5538.IBJU.2024.0494.

  PMID: 40079922 BACKGROUND

• Tian Y, Lv H, Jumai A, Tuerhong T, Zhuang L, Huang J, Li J, Lu P, Tao G, Yamauchi Y, Flores RM, Teng H, Chen T, Luo Q. Ultra-remote robot-assisted right upper lobectomy between the Shanghai and Kashi Prefectures: a case report. J Thorac Dis. 2024 Dec 31;16(12):8823-8830. doi: 10.21037/jtd-24-1605. Epub 2024 Dec 27.

  PMID: 39831214 BACKGROUND

• Aldousari S, Almarzouq A, Hassan A, Shahin A, Bubishate S, Bahbahani B. The era of telesurgery: insights from ultra-long-distance Asia to Middle East human telesurgery robotic assisted radical prostatectomy. J Robot Surg. 2025 Mar 11;19(1):108. doi: 10.1007/s11701-025-02274-9.

  PMID: 40064737 BACKGROUND

• Rocco B, Moschovas MC, Saikali S, Gaia G, Patel V, Sighinolfi MC. Insights from telesurgery expert conference on recent clinical experience and current status of remote surgery. J Robot Surg. 2024 Jun 4;18(1):240. doi: 10.1007/s11701-024-01984-w.

  PMID: 38833111 BACKGROUND

• Moschovas MC, Dohler M, Patel V. Telesurgery: Challenges, Ethical Considerations, and Opportunities in the Robotic Surgery Era. Eur Urol Focus. 2025 Jan;11(1):40-42. doi: 10.1016/j.euf.2025.02.016. Epub 2025 Mar 3.

  PMID: 40037973 BACKGROUND

• Moschovas MC, Saikali S, Dohler M, Patel E, Rogers T, Gamal A, Marquinez J, Patel V. Advancing Telesurgery Connectivity Between North and South America: the first Remote Surgery Conducted Between Orlando and Sao Paulo in Animal Models. Int Braz J Urol. 2025 Jan-Feb;51(1):e20240601. doi: 10.1590/S1677-5538.IBJU.2024.0601. No abstract available.

  PMID: 39556854 BACKGROUND

• Moschovas MC, Palmer K, Barani G, Corder C, Carnegie P, Dhanji T, Patel E, Paxi A, Figueiredo JC, Luis B, Matos A, Dohler M, Patel V. Expanding access to high-quality surgical care in Africa: a landmark achievement in telesurgery. J Robot Surg. 2025 Mar 24;19(1):124. doi: 10.1007/s11701-025-02292-7.

  PMID: 40128381 BACKGROUND

• Moschovas MC, Saikali S, Rogers T, Dohler M, Mcdonald M, Patel E, Marquinez J, Gamal A, Magnuson J, Patel V. Exploring the Teleproctoring Potential of Telesurgery: The First Remote Procedures Performed Simultaneously Between Orlando and Shanghai. Int Braz J Urol. 2025 Jul-Aug;51(4):e20250083. doi: 10.1590/S1677-5538.IBJU.2025.0083.

  PMID: 40112129 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Bernardo Rocco

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BERNARDO B ROCCO, MD

CONTACT

+393358306522; bernardomariacesare.rocco@policlinicogemelli.it

Maria Chiara MC Sighinolfi, md,phD

CONTACT

+393921329216; mariachiara.sighinolfi@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of urology

Model Details: Single-arm prospective interventional study evaluating the feasibility and safety of a telesurgery program during robot-assisted surgical procedures performed at a tertiary referral center.

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 28, 2026
• Study Start: August 20, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)