Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Vacuum-Assisted Mini-Percutaneous Versus Transurethral Cystolithotripsy in Pediatric Bladder Stones (VAMPCL-Ped)

22. maj 2026 opdateret af: Hany Fathy Badawy, MD, Beni-Suef University

Vacuum-Assisted Mini-Percutaneous Cystolithotomy Versus Transurethral Cystolithotripsy in Pediatric Bladder Stones: A Prospective Randomized Study

This prospective randomized pilot study will compare vacuum-assisted mini-percutaneous cystolithotripsy with standard transurethral cystolithotripsy for the treatment of bladder stones in children. Forty children aged 2 to 14 years with bladder stone(s) measuring 10-30 mm will be randomly assigned to one of two surgical approaches. The vacuum-assisted mini-percutaneous group will undergo suprapubic percutaneous access using a mini sheath with suction-assisted fragment evacuation, while the transurethral group will undergo standard transurethral cystolithotripsy. The primary outcome will be total operative time. Secondary outcomes will include stone-free rate, lithotripsy and fragment clearance time, urethral mucosal injury, postoperative hematuria, fever, urinary tract infection, sepsis, urinary retention, urinary leakage from the suprapubic tract, catheterization time, hospital stay, postoperative pain, analgesic requirement, need for auxiliary procedures or conversion, and recurrence or urethral stricture-related symptoms during follow-up.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Bladder stones in children remain a relevant urological condition, particularly in settings where nutritional, metabolic, infectious, or hydration-related factors may contribute to stone formation. Minimally invasive endoscopic management has largely replaced open cystolithotomy in many centers. Transurethral cystolithotripsy is commonly used, but in young children the small urethral caliber may make repeated instrumentation and fragment extraction technically challenging and may raise concern about urethral mucosal trauma. Percutaneous cystolithotripsy provides an alternative route that may reduce repeated transurethral fragment extraction.

Vacuum-assisted mini-percutaneous cystolithotripsy uses a suprapubic percutaneous access tract and a suction-assisted sheath to maintain visibility and facilitate evacuation of stone dust and fragments during laser lithotripsy. However, pediatric comparative evidence remains limited.

This study is designed as a prospective randomized controlled pilot study including 40 children with bladder stone(s) measuring 10-30 mm. Eligible patients will be randomized in a 1:1 ratio to vacuum-assisted mini-percutaneous cystolithotripsy or transurethral cystolithotripsy. Both procedures will be performed under general anesthesia using Ho:YAG laser lithotripsy. Patients will be followed postoperatively to assess operative, perioperative, and follow-up outcomes. The study aims to generate preliminary comparative data on operative time, safety, stone clearance, postoperative recovery, and follow-up urinary outcomes to inform future adequately powered trials.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Egypten
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egypten
        • Rekruttering
        • Urology Department - Beni-Suef University Hospitals
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Hany Fathy Badawy, MD

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:

Children aged 2 to 14 years. Diagnosis of bladder stone or stones measuring 10-30 mm in maximum cumulative diameter, confirmed by ultrasound.

Normal upper urinary tract. Fit for general anesthesia. Written informed consent obtained from parents or legal guardians.

Exclusion Criteria:

Known urethral stricture or posterior urethral valves. Active urinary tract infection at the time of surgery. Coagulopathy or uncorrected bleeding disorder. Previous open bladder surgery. Any anatomical or clinical condition that, in the investigator's judgment, precludes safe endoscopic or percutaneous cystolithotripsy.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Vacuum-Assisted Mini-Percutaneous Cystolithotripsy
Participants randomized to this arm will undergo vacuum-assisted mini-percutaneous cystolithotripsy under general anesthesia using suprapubic percutaneous bladder access and a suction-assisted mini sheath. Ho:YAG laser lithotripsy will be used for stone fragmentation, with suction-assisted evacuation of stone dust and fragments.
Procedure: Vacuum-Assisted Mini-Percutaneous Cystolithotripsy
Surgical treatment of pediatric bladder stones using suprapubic mini-percutaneous bladder access, a suction-assisted mini sheath, and Ho:YAG laser lithotripsy for stone fragmentation and evacuation
Aktiv komparator: Transurethral Cystolithotripsy
Participants randomized to this arm will undergo standard transurethral cystolithotripsy under general anesthesia using the smallest appropriate pediatric semi-rigid ureteroscope. Ho:YAG laser lithotripsy will be used for stone fragmentation, with fragment evacuation through the transurethral route
Procedure: Transurethral Cystolithotripsy
Standard transurethral endoscopic treatment of pediatric bladder stones using an appropriate pediatric semi-rigid ureteroscope with Ho:YAG laser lithotripsy and transurethral fragment evacuation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total Operative Time
Tidsramme: Intraoperative
Total operative time will be defined as the time from insertion of the first endoscopic instrument to completion of stone clearance and urethral catheter placement, measured in minutes.
Intraoperative

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stone-Free Rate
Tidsramme: 4 weeks postoperatively

Stone-free rate will be defined as the proportion of patients with no residual bladder stone fragments on postoperative pelvi abdominl ultrasound. Low-dose non-contrast CT urinary tract will be reserved for equivocal ultrasound findings.

Time Frame: 4 weeks postoperatively
4 weeks postoperatively
Urethral Mucosal Injury
Tidsramme: Intraoperatively
Occurrence of visible urethral mucosal injury detected intraoperatively.
Intraoperatively
Lithotripsy and Fragment Clearance Time
Tidsramme: Intraoperative
Time from initiation of laser lithotripsy to endoscopic confirmation of complete stone clearance, measured in minutes.
Intraoperative
Recurrence or Urethral Stricture-Related Symptoms
Tidsramme: 6 months postoperatively
Occurrence of recurrent bladder stone symptoms, abnormal urinary stream, suspected urethral stricture symptoms, or need for further diagnostic evaluation
6 months postoperatively

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beni-Suef University

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)

4. marts 2026

Primær færdiggørelse (Anslået)

1. februar 2028

Studieafslutning (Anslået)

1. marts 2028

Datoer for studieregistrering

Først indsendt

22. maj 2026

Først indsendt, der opfyldte QC-kriterier

22. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FMBSUREC03032026Ahmed
  • FMBSUREC/03032026/Ahmed (Anden identifikator: Research Ethics Committee, Faculty of Medicine, Beni-Suef University)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared because the study involves pediatric participants and individual-level clinical data. Only aggregated, de-identified study results will be reported in publications. Any future data sharing request will require approval from the Research Ethics Committee, Faculty of Medicine, Beni-Suef University.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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 .

Kliniske forsøg med Pædiatriske blæresten

Kliniske forsøg med Vacuum-Assisted Mini-Percutaneous Cystolithotripsy

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Portugal

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner