Vacuum-Assisted Mini-Percutaneous Versus Transurethral Cystolithotripsy in Pediatric Bladder Stones (VAMPCL-Ped)
Vacuum-Assisted Mini-Percutaneous Cystolithotomy Versus Transurethral Cystolithotripsy in Pediatric Bladder Stones: A Prospective Randomized Study
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Beni Suweif Governorate
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Banī Suwayf, Beni Suweif Governorate, Ägypten
- Rekrutierung
- Urology Department - Beni-Suef University Hospitals
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Kontakt:
- Hany Fathy Badawy, MD
- Telefonnummer: +201149525028
- E-Mail: Hanyfathy86@gmail.com
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Kontakt:
- Mahmoud Abdallah, Md
- Telefonnummer: +20 11 55361979
- E-Mail: Drhanyfathy86@gmail.com
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Hauptermittler:
- Hany Fathy Badawy, MD
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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.
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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
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Aktiver 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
|
Standard transurethral endoscopic treatment of pediatric bladder stones using an appropriate pediatric semi-rigid ureteroscope with Ho:YAG laser lithotripsy and transurethral fragment evacuation
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Total Operative Time
Zeitfenster: Intraoperative
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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.
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Intraoperative
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Stone-Free Rate
Zeitfenster: 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
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Urethral Mucosal Injury
Zeitfenster: Intraoperatively
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Occurrence of visible urethral mucosal injury detected intraoperatively.
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Intraoperatively
|
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Lithotripsy and Fragment Clearance Time
Zeitfenster: Intraoperative
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Time from initiation of laser lithotripsy to endoscopic confirmation of complete stone clearance, measured in minutes.
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Intraoperative
|
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Recurrence or Urethral Stricture-Related Symptoms
Zeitfenster: 6 months postoperatively
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Occurrence of recurrent bladder stone symptoms, abnormal urinary stream, suspected urethral stricture symptoms, or need for further diagnostic evaluation
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6 months postoperatively
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Männliche Urogenitalerkrankungen
- Kalkül
- Pathologische Zustände, Anatomisch
- Urologische Erkrankungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Urolithiasis
- Harnsteine
- Erkrankungen der Harnblase
- Pathologische Zustände, Anzeichen und Symptome
- Harnblasensteine
Andere Studien-ID-Nummern
- FMBSUREC03032026Ahmed
- FMBSUREC/03032026/Ahmed (Andere Kennung: FM-BSU REC)
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Beschreibung des IPD-Plans
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