Dusting vs Fragmentation Laser Cystolithotripsy for Pediatric Bladder Stones (DUST-FRAG-PED)
Dusting Versus Fragmentation With Holmium:YAG Laser During Transurethral Cystolithotripsy in Pediatric Bladder Stones: A Prospective Randomized Trial
Bladder stones are a clinically relevant pediatric urological condition that may require endoscopic treatment. Transurethral Holmium:YAG laser cystolithotripsy is a minimally invasive option for selected children with bladder stones.
This prospective randomized trial will compare two Holmium:YAG laser strategies during transurethral cystolithotripsy in children with a single bladder stone less than 3 cm: dusting and fragmentation. Children will be randomized to undergo laser dusting or laser fragmentation during transurethral cystolithotripsy.
The primary outcome is total operative time. Secondary outcomes include laser time, need for active fragment extraction, endoscopic stone-free status at the end of the procedure, ultrasound-assessed stone-free status during follow-up, intraoperative complications, postoperative urinary symptoms, urinary tract infection, need for postoperative catheterization, and hospital stay.
Studienübersicht
Status
Detaillierte Beschreibung
This is a prospective randomized controlled trial conducted at the Department of Urology, Faculty of Medicine, Beni-Suef University Hospital.
The study will include children with radiologically confirmed single bladder stones less than 3 cm who are planned for transurethral Holmium:YAG laser cystolithotripsy and are suitable for transurethral endoscopic management under general anesthesia. Written informed consent will be obtained from parents or legal guardians before enrollment.
Eligible children will be randomized in a 1:1 ratio into two groups. Participants in the dusting group will undergo transurethral Holmium:YAG laser cystolithotripsy using low pulse energy and higher pulse frequency settings, with the aim of reducing the stone into fine particulate debris and tiny fragments with minimal need for active extraction. Participants in the fragmentation group will undergo transurethral Holmium:YAG laser cystolithotripsy using higher pulse energy and lower pulse frequency settings, with the aim of producing visible extractable fragments that can be actively removed when needed.
All procedures will be performed under general anesthesia in the lithotomy position using a pediatric semi-rigid ureteroscope. A Holmium:YAG laser will be used in both groups. The planned settings are 0.5-0.8 J and 10-15 Hz in the dusting group, and 1.0 J and 6-10 Hz in the fragmentation group. A 550-micron end-firing laser fiber will be preferred when compatible with the available endoscope.
The primary outcome is total operative time, defined as the time in minutes from insertion of the endoscope into the urethra until completion of stone clearance and termination of the procedure, including fragment retrieval when required. Secondary outcomes include laser time, need for active fragment extraction, endoscopic stone-free status at the end of the procedure, ultrasound-assessed stone-free status at follow-up, intraoperative mucosal injury or bleeding, need for postoperative catheterization, postoperative hematuria, dysuria, urinary tract infection, and hospital stay. Follow-up will be scheduled at 1 week, 1 month, and 3 months with clinical assessment and ultrasonography.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Hany F Badawy, MD
- Telefonnummer: +201149525028
- E-Mail: Hanyfathy86@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Ghada S Etman, MD
- Telefonnummer: +2010 07913852
- E-Mail: DrhanYFATHY86@GMAIL.COM
Studienorte
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Beni Suweif Governorate
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Banī Suwayf, Beni Suweif Governorate, Ägypten
- Rekrutierung
- Department of Urology- Beni-Suef University Hospitals
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Kontakt:
- Hany F Badawy, MD
- Telefonnummer: +201149525028
- E-Mail: Hanyfathy86@gmail.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Children aged less than 18 years.
- Radiologically confirmed single bladder stone less than 3 cm.
- Suitable for transurethral cystolithotripsy.
- Fit for general anesthesia.
- Written informed consent from parents or legal guardians.
Exclusion Criteria:
- Giant bladder stones more than 3 cm.
- Urethral pathology preventing safe transurethral access.
- Major lower urinary tract anomaly or neurogenic bladder.
- Active untreated urinary tract infection.
- Coagulation disorder or contraindication to endoscopic surgery.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Dusting
Participants will undergo transurethral Holmium:YAG laser cystolithotripsy using a dusting strategy with low pulse energy .
The planned settings are 0.5-0.8
J and 10-15 Hz, aiming to reduce the bladder stone into fine particulate debris and tiny fragments with minimal need for active fragment extraction.
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Transurethral Holmium:YAG laser cystolithotripsy using a dusting strategy with planned laser settings of 0.5-0.8
J and 10-15 Hz, aiming to reduce the bladder stone into fine particulate debris and tiny fragments with minimal need for active fragment extraction.
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Aktiver Komparator: Fragmentation
Participants will undergo transurethral Holmium:YAG laser cystolithotripsy using a fragmentation strategy with higher pulse energy.
The planned settings are 1.0 J and 6-10 Hz, aiming to produce visible extractable stone fragments, approximately 2-5 mm, with active fragment removal when needed.
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Transurethral Holmium:YAG laser cystolithotripsy using a fragmentation strategy with planned laser settings of 1.0 J and 6-10 Hz, aiming to produce visible extractable stone fragments of approximately 2-5 mm, with active fragment removal when needed.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Total Operative Time
Zeitfenster: During the index transurethral cystolithotripsy procedure
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Total operative time will be measured in minutes from insertion of the endoscope into the urethra until completion of bladder stone clearance and termination of the procedure, including active fragment retrieval when required.
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During the index transurethral cystolithotripsy procedure
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Laser Time
Zeitfenster: During the index transurethral cystolithotripsy procedure
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Laser time will be measured in minutes as the cumulative duration of active Holmium:YAG laser firing during the index transurethral cystolithotripsy procedure.
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During the index transurethral cystolithotripsy procedure
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Need for Active Fragment Extraction
Zeitfenster: During the index transurethral cystolithotripsy procedure
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The need for active fragment extraction will be recorded as whether stone fragments required active removal using endoscopic retrieval maneuvers during the index transurethral cystolithotripsy procedure. |
During the index transurethral cystolithotripsy procedure
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Endoscopic Stone-Free Status at the End of the Procedure
Zeitfenster: At the end of the index transurethral cystolithotripsy proced
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Endoscopic stone-free status will be assessed at the end of the procedure and defined as no visible residual bladder stone fragments on final endoscopic inspection.
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At the end of the index transurethral cystolithotripsy proced
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Postoperative Hematuria
Zeitfenster: From the end of the procedure to 1 month postoperatively
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Postoperative hematuria will be recorded based on clinical observation or patient/guardian report during postoperativ follow-up.
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From the end of the procedure to 1 month postoperatively
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Hany F Badawy, MD, Faculty of Medicine, Beni-Suef University hospital
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
- FMBSUREC05052026BadawyDF
- FMBSUREC/05052026/Badawy (Andere Kennung: FM-BSU REC)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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