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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2025-A01443-46 |
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Open surgery (laparotomy) has long been the gold standard for pediatric surgery. The development of laparoscopy in the 1980s reduced post-operative pain. Since the 2000s, robotic surgery has been on the rise. The most commonly used robotic system is the Xi robotic system (Intuitive Surgical), which allows instruments to be inserted through three or four trocars and replicates the movements of the surgeon's hands as they sit at a control console a few meters away from the patient.The Single Port (SP) robotic system is a new development in this technology. It allows the same procedures to be performed using a single trocar instead of four. CE marking was obtained in 2024 for abdominal surgery, but without provision for use in children. The pediatric surgery team at Saint-Etienne University Hospital has been performing robotic surgery using the Xi (Intuitive) system since January 2020. Between January 2020 and April 2025, 150 patients underwent surgery, including 49 pyeloplasties, 42 ureterovesical reimplantations, and 23 gastroesophageal reflux treatments. No conversions were necessary, and there were no complications related to the use of the robotic system. The Saint-Etienne University Hospital was the first institution in France to acquire the SP robotic system.
The main objective of this study is to evaluate the feasibility of robotic surgery (pyeloplasty, ureterovesical reimplantation, treatment of gastroesophageal reflux) using the new Single Port robotic system to treat minors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic surgery procedures on minors | Experimental | Robotic surgery on minors to assess the feasibility of robotic surgery (pyeloplasty, ureterovesical reimplantation, treatment of gastroesophageal reflux) using the new Singleport robotic system to treat minors. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Singleport robotic system to treat minors | Procedure | Robotic surgery on minors to assess the feasibility of robotic surgery (pyeloplasty, ureterovesical reimplantation, treatment of gastroesophageal reflux) using the new Singleport robotic system to treat minors. |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion use | A conversion refers to discontinuing use of the SinglePort robotic system to complete the procedure using another surgical technique. | Day 1 : surgery day |
| Duration of surgery under general anesthesia | Excessive operating time : over 7 hours | Day 1 : surgery day |
| Complications related to the use of the SP robotic system | Any digestive or vascular wound or organ damage caused by a conflict between instruments, or by a technical difficulty in handling the instruments, or occurring during the installation of the system or during the introduction of surgical instruments into the abdominal cavity will be considered a complication related to the use of the SP robotic system. | Day 1 : surgery day |
| Measure | Description | Time Frame |
|---|---|---|
| Operating time estimation | Estimate the operating time in minutes | Day 1 : surgery day |
| "console time" estimation | Estimate the "console time" in minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aurélien SCALABRE, PHD | Contact | (0)4 77 82 80 37 | +33 | aurelien.scalabre@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Aurelien Scalabre, PHD | CHU DE SAINT-ETIENNE HOPITAL NORD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu de Saint-Etienne Hopital Nord | Recruiting | Saint-Etienne | 42055 | France |
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Single-center, single-arm study following Simon's two-stage plan. This is a preliminary descriptive study aimed at demonstrating the feasibility of a new surgical technique.
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| Day 1 : surgery day |
| Consumption of level III pain medication assessment | Assessment of the amount of painkillers taken post-operatively | From 4 at 6 weeks post surgery |