Use of the Single Port Robotic System in Pediatric Surgery

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• Conversion use [Срок оценки: Day 1 : surgery day]
• Duration of surgery under general anesthesia [Срок оценки: Day 1 : surgery day]
• Complications related to the use of the SP robotic system [Срок оценки: Day 1 : surgery day]

Вторичные конечные точки (3)

• Operating time estimation [Срок оценки: Day 1 : surgery day]
• "console time" estimation [Срок оценки: Day 1 : surgery day]
• Consumption of level III pain medication assessment [Срок оценки: From 4 at 6 weeks post surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Chu de Saint-Etienne Hopital Nord — Saint-Etienne

Идентификаторы

NCT: NCT07660497 · 25CH168 · ANSM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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