Use of the Single Port Robotic System in Pediatric Surgery (SPCHIRPED)

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric; Surgery in Children; Robotic System
• Intervention / Treatment: Procedure: Singleport robotic system to treat minors

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: AURELIEN SCALABRE, PHD; Phone Number: +33 (0)4 77 82 80 37; Email: aurelien.scalabre@chu-st-etienne.fr

Study Locations

• France
  • Saint-Etienne, France, 42055
    • Recruiting
    • Chu de Saint-Etienne Hopital Nord
    • Contact: AURELIEN SCALABRE, PHD; Phone Number: +33 (0)4 77 82 80 37; Email: aurelien.scalabre@chu-st-etienne.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic surgery procedures on 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversion use	A conversion refers to discontinuing use of the SinglePort robotic system to complete the procedure using another surgical technique.	Day 1 : surgery day
Duration of surgery under general anesthesia	Excessive operating time : over 7 hours	Day 1 : surgery day
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.	Day 1 : surgery day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operating time estimation	Estimate the operating time in minutes	Day 1 : surgery day
"console time" estimation	Estimate the "console time" in minutes	Day 1 : surgery day
Consumption of level III pain medication assessment	Assessment of the amount of painkillers taken post-operatively	From 4 at 6 weeks post surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Aurelien Scalabre, PHD, Chu de Saint-Etienne Hopital Nord

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Pediatric surgery; Single Port Robotic System; Access Port
• Other Study ID Numbers: 25CH168; ANSM (Other Identifier: 2021-A02121-40)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No