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This study involves a type of robotic surgery called telesurgery, where a highly trained surgeon performs the surgical procedure using a secure internet connection to operate on a patient in a different location. Urologists from The goal of this study is to find out how safe and effective telesurgery is when used in real hospitals. The study aims to understand how well Telesurgery works in different settings, what technical challenges might come up (like internet speed or delays), and how it can be used to train new surgeons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exploring the Potential of Robotic Telesurgery in Remote Settings | Experimental | Telesurgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telesurgery utilizing Microport Medbot Robotic Platform | Device | A robotic surgery for prostate disease via telesurgery, where a highly trained surgeon performs the operation remotely using a secure internet connection. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measures (Endpoints) | One of the investigator's primary outcome measures is the safety and feasibility of the Microport Medbot Robotic Platform for use in Telesurgery through maintaining a stable connection. The investigator will monitor feasibility through perioperative connectivity assessment provided by the platform. Outcome of Latency- Medbot platform measures in milliseconds. This is monitored by the investigator. Measured in Milliseconds per round trip time (ms/RTT). The acceptable threshold is under 200ms. Robotic Platform Performance Logs- The robotic system itself continuously logs and reports performance metrics, including latency. Dedicated Tech team: Oversees and monitors connection status throughout procedure. | The measured time frame for this outcome will be measured by the investigator and tech team from the start of the surgical procedure through the stop time of the surgical procedure. Approximately 90 minutes in length. |
| Secondary Endpoints | Investigators assessment of and response to perioperative complications (complications observed will be classified using the Clavien-Dindo Classification with Grades I thru V). | This will be measured by the investigator from the start of the surgical procedure through the completion of the surgical procedure. |
| Safety and Feasibility: Maintenance of stable connection | One of the investigator's primary outcome measures is the safety and feasibility of the Microport Medbot Robotic Platform for use in Telesurgery through maintaining a stable connection. The investigator will monitor feasibility through perioperative connectivity Outcome: Bandwidth and Network Stability- The surgical team monitors bandwidth to ensure a consistent, high-speed internet connection. Bandwidth measured in megabits per second (Mbps). The goal of 100Mbps is recommended. Measurement is made through tracking on data transmission rates reported by the robotic system itself which continuously logs and reports data in real time. Dedicated Tech Team: Oversees and monitors connection status throughout the procedure. | The measured time frame for this outcome will be measured by the investigator and tech team from the start of the surgical procedure through the stop time of the surgical procedure. Approximately 90 minutes in length. |
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Inclusion Criteria:
Age 18 - 90
Male or female
Eligible participants for this telesurgery study must have a clearly defined indication for robotic urologic surgery, specifically:
OR
-Benign Prostate diseases appropriate for robotic simple prostatectomy (ICD-10: N40) These diagnoses are confirmed by clinical examination, imaging, and/or pathology prior to surgical planning. Patients with vague or unspecified urologic conditions will be excluded to ensure the safety and appropriateness of the surgical intervention.
Exclusion Criteria:
Patients who, based on multidisciplinary evaluation (surgical, anesthetic, and medical), are deemed not suitable for robotic surgery due to high perioperative risk. This includes but is not limited to:
Patients enrolled in another interventional research study that may interfere with surgical safety or outcomes.
Patients unwilling or unable to comply with the perioperative and follow-up schedule.
Vulnerable populations are excluded from this study, including:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth | Recruiting | Celebration | Florida | 34747 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38833111 | 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. | |
| 39435556 | Background | Reddy SK, Saikali S, Gamal A, Moschovas MC, Rogers T, Dohler M, Marescaux J, Patel V. Telesurgery: A Systematic Literature Review and Future Directions. Ann Surg. 2025 Aug 1;282(2):219-227. doi: 10.1097/SLA.0000000000006570. Epub 2024 Oct 22. |
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We plan to publish multiple articles during the study, using the full de-identified dataset from all patients or focusing on specific subsets of the data to highlight particular types of surgeries or groups of procedures.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D011469 | Prostatic Diseases |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 39502103 | Background | Patel V, Dohler M, Marescaux J, Saikali S, Gamal A, Reddy S, Rogers T, Patel E, Oliva R, Satava R, Moschovas MC. Expanding Surgical Frontiers Across the Pacific Ocean: Insights from the First Telesurgery Procedures Connecting Orlando with Shanghai in Animal Models. Eur Urol Open Sci. 2024 Oct 21;70:70-78. doi: 10.1016/j.euros.2024.09.009. eCollection 2024 Dec. |
| 39549181 | Background | Dohler M, Saikali S, Gamal A, Moschovas MC, Patel V. The crucial role of 5G, 6G, and fiber in robotic telesurgery. J Robot Surg. 2024 Nov 16;19(1):4. doi: 10.1007/s11701-024-02164-6. |
| 39556854 | 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. |
| 38819496 | Background | Patel V, Moschovas MC, Marescaux J, Satava R, Dasgupta P, Dohler M. Telesurgery collaborative community working group: insights about the current telesurgery scenario. J Robot Surg. 2024 May 31;18(1):232. doi: 10.1007/s11701-024-01995-7. No abstract available. |
| 38762391 | Background | Patel V, Marescaux J, Covas Moschovas M. The Humanitarian Impact of Telesurgery and Remote Surgery in Global Medicine. Eur Urol. 2024 Aug;86(2):88-89. doi: 10.1016/j.eururo.2024.04.029. Epub 2024 May 18. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |