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NCT Number: NCT07660497

Use of the Single Port Robotic System in Pediatric Surgery

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.

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Key information

Conditions

Robotic System Pediatric Surgery in Children

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Saint-Etienne Hopital Nord

Saint-Etienne, 42055, France

Location status: Recruiting

Location contact

AURELIEN SCALABRE, PHD

CONTACT

[email protected]

(0)4 77 82 80 37 ext. +33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Conversion use

    Time frame: Day 1 : surgery day

    A conversion refers to discontinuing use of the SinglePort robotic system to complete the procedure using another surgical technique.

  2. Duration of surgery under general anesthesia

    Time frame: Day 1 : surgery day

    Excessive operating time : over 7 hours

  3. Complications related to the use of the SP robotic system

    Time frame: 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 outcomes

  1. Operating time estimation

    Time frame: Day 1 : surgery day

    Estimate the operating time in minutes

  2. "console time" estimation

    Time frame: Day 1 : surgery day

    Estimate the "console time" in minutes

  3. Consumption of level III pain medication assessment

    Time frame: From 4 at 6 weeks post surgery

    Assessment of the amount of painkillers taken post-operatively

Study contacts

Contact information is provided by the study sponsor or research team.

Aurélien SCALABRE, PHD

CONTACT

[email protected]

(0)4 77 82 80 37 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: SPCHIRPED

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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