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

Qualifiers

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

Treatments tested in this trial

  • Singleport robotic system to treat minors

Treatment groups

10 Participants
are divided into 1 treatment group