Use of the Single Port Robotic System in Pediatric Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-17
SponsorCentre Hospitalier Universitaire de Saint Etienne
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Singleport robotic system to treat minors
Procedure/SurgeryRobotic 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Robotic surgery procedures on minorsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Conversion use
A conversion refers to discontinuing use of the SinglePort robotic system to complete the procedure using another surgical technique.
Time frame
Day 1 : surgery day2
Duration of surgery under general anesthesia
Excessive operating time : over 7 hours
Time frame
Day 1 : surgery day3
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.
Time frame
Day 1 : surgery daySecondary outcomes
1
Operating time estimation
Estimate the operating time in minutes
Time frame
Day 1 : surgery day2
"console time" estimation
Estimate the "console time" in minutes
Time frame
Day 1 : surgery day3
Consumption of level III pain medication assessment
Assessment of the amount of painkillers taken post-operatively
Time frame
From 4 at 6 weeks post surgerySponsors and contacts
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Source ClinicalTrials.gov