Pediatric, Robotic System, Surgery in Children
Conditions
Keywords
Single Port Robotic System, Pediatric surgery, Access Port
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURESingleport robotic system to treat minors
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.
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 10 and 17 inclusive for the first five and between 1 and 17 for the next five * Parents or guardians affiliated with or entitled to social security * Patient and legal representative of the patient who has received informed information about the study and has signed the consent form for the child's participation in the study. * Patients seen in paediatric surgery consultations at Saint-Etienne University Hospital * Patient requiring abdominal surgery such as pyeloplasty, vesicoureteral reflux or gastro-oesophageal reflux
Exclusion criteria
* History of haemorrhagic disease * History of multiple abdominal surgeries (as intraperitoneal adhesions can make surgical access difficult) * Pregnant adolescents * Patients with electronic implants (e.g. pacemakers). * Parents or guardians under guardianship or trusteeship.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conversion use | Day 1 : surgery day | A conversion refers to discontinuing use of the SinglePort robotic system to complete the procedure using another surgical technique. |
| Duration of surgery under general anesthesia | Day 1 : surgery day | Excessive operating time : over 7 hours |
| Complications related to the use of the SP robotic system | Day 1 : surgery day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operating time estimation | Day 1 : surgery day | Estimate the operating time in minutes |
| "console time" estimation | Day 1 : surgery day | Estimate the "console time" in minutes |
| Consumption of level III pain medication assessment | From 4 at 6 weeks post surgery | Assessment of the amount of painkillers taken post-operatively |
Countries
France
Contacts
CONTACTAurélien SCALABRE, PHD
PRINCIPAL_INVESTIGATORAurelien Scalabre, PHD
CHU DE SAINT-ETIENNE HOPITAL NORD
Outcome results
None listed