Use of the Single Port Robotic System in Pediatric Surgery (SPCHIRPED)
16. juni 2026 opdateret af: Centre Hospitalier Universitaire de Saint Etienne
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
10
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: AURELIEN SCALABRE, PHD
- Telefonnummer: +33 (0)4 77 82 80 37
- E-mail: aurelien.scalabre@chu-st-etienne.fr
Studiesteder
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Saint-Etienne, Frankrig, 42055
- Rekruttering
- Chu de Saint-Etienne Hopital Nord
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Kontakt:
- AURELIEN SCALABRE, PHD
- Telefonnummer: +33 (0)4 77 82 80 37
- E-mail: aurelien.scalabre@chu-st-etienne.fr
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Conversion use
Tidsramme: Day 1 : surgery day
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A conversion refers to discontinuing use of the SinglePort robotic system to complete the procedure using another surgical technique.
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Day 1 : surgery day
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Duration of surgery under general anesthesia
Tidsramme: Day 1 : surgery day
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Excessive operating time : over 7 hours
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Day 1 : surgery day
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Complications related to the use of the SP robotic system
Tidsramme: Day 1 : surgery day
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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.
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Day 1 : surgery day
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Operating time estimation
Tidsramme: Day 1 : surgery day
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Estimate the operating time in minutes
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Day 1 : surgery day
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"console time" estimation
Tidsramme: Day 1 : surgery day
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Estimate the "console time" in minutes
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Day 1 : surgery day
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Consumption of level III pain medication assessment
Tidsramme: From 4 at 6 weeks post surgery
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Assessment of the amount of painkillers taken post-operatively
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From 4 at 6 weeks post surgery
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Aurelien Scalabre, PHD, Chu de Saint-Etienne Hopital Nord
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. november 2025
Primær færdiggørelse (Anslået)
1. december 2026
Studieafslutning (Anslået)
15. december 2026
Datoer for studieregistrering
Først indsendt
16. juni 2026
Først indsendt, der opfyldte QC-kriterier
16. juni 2026
Først opslået (Faktiske)
22. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 25CH168
- ANSM (Anden identifikator: 2017-A03433-50)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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