Use of the Single Port Robotic System in Pediatric Surgery

NCT07660497 | Recruiting DMC

• 2 other identifiers: 25CH168ANSM
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Robotic System; Pediatric; Surgery in Children

Keywords

Single Port Robotic System; Pediatric surgery; Access Port

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Operating time estimation

  Day 1 : surgery day

• "console time" estimation

  Day 1 : surgery day

• Consumption of level III pain medication assessment

  From 4 at 6 weeks post surgery

Study Arms (1)

Robotic surgery procedures on minors

EXPERIMENTAL

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

Interventions

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.

Robotic surgery procedures on minors

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu de Saint-Etienne Hopital Nord

Saint-Etienne, 42055, France

RECRUITING

Study Officials

• Aurelien Scalabre, PHD

  CHU DE SAINT-ETIENNE HOPITAL NORD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurélien SCALABRE, PHD

CONTACT

(0)4 77 82 80 37; aurelien.scalabre@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, single-arm study following Simon's two-stage plan. This is a preliminary descriptive study aimed at demonstrating the feasibility of a new surgical technique.

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: November 14, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

FR (1)