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Recruiting NCT07660497

Use of the Single Port Robotic System in Pediatric Surgery

No phase Interventional Robotic System Pediatric Surgery in Children

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Singleport robotic system to treat minors.
Who it may be relevant to
Registry conditions: Robotic System, Pediatric, Surgery in Children. Basic parameters: 1 year — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

  • Procedure Singleport 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.

Primary outcome measures

  • Conversion use [Time frame: Day 1 : surgery day]
  • Duration of surgery under general anesthesia [Time frame: Day 1 : surgery day]
  • Complications related to the use of the SP robotic system [Time frame: Day 1 : surgery day]
Secondary outcome measures (3)
  • Operating time estimation [Time frame: Day 1 : surgery day]
  • "console time" estimation [Time frame: Day 1 : surgery day]
  • Consumption of level III pain medication assessment [Time frame: From 4 at 6 weeks post surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Chu de Saint-Etienne Hopital Nord — Saint-Etienne

Identifiers

NCT: NCT07660497 · 25CH168 · ANSM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗