Retrograde Intrarenal Surgery Versus Mini Percutaneous Nephrolithotomy
Retrograde Intrarenal Surgery Versus Mini Percutaneous Nephrolithotomy In Management Of Pediatric Renal Stone Less Than 2 Cm: A Prospective Randomized Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Pediatric nephrolithiasis accounts for approximately 2-3% of all stone disease cases, with recent reports indicating a rising prevalence of up to 10.6%.Multiple treatment modalities are currently available, ranging from non-invasive pharmacologic options to minimally invasive techniques such as extracorporeal shockwave lithotripsy (ESWL), retrograde intrarenal surgery (RIRS), and percutaneous nephrolithotomy (PCNL).
Treatment selection is primarily guided by stone size, location, and complexity. Importantly, the chosen intervention should aim to achieve a high stone-free rate (SFR) with the lowest possible complication rate.
Minimally invasive technique is considered the first-line of treatment for renal stones in children due to its favorable safety profile and minimally invasive nature. In such cases, endourological options like RIRS and mini-PCNL serve as favourable line of treatments.
RIRS is a minimally invasive procedure that offers advantages such as reduced perioperative morbidity, lower bleeding risk, and quicker recovery compared to mini PCNL. Nonetheless, its stone clearance rate may be inferior to mini PCNL, particularly for larger stones. RIRS often requires DJ stenting and may lead to repeated interventions, which can result in lower urinary tract symptoms (LUTS) and negative impact on quality of life.
Mini-PCNL, although highly effective, carries a higher risk of complications, including bleeding and adjucnt oragan injury particularly due to tract dilation.To reduce these risks, modified PCNL techniques have been introduced, such as ultramini-PCNL, and micro-PCNL. These smaller-caliber systems have demonstrated greater safety profiles in children and higher efficacy than ESWL, making them promising in pediatric stone management.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Mostafa Mahmoud Rashed Ali, M.D
- Telefonnummer: +20111049435
- E-mail: Mostafarashed2222@gmail.com
Undersøgelse Kontakt Backup
- Navn: Atef Fathi Ali, professor
- Telefonnummer: +201099051714
- E-mail: Ateffathi2010@yahoo.com
Studiesteder
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South Valley
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Qina, South Valley, Egypten
- Rekruttering
- South Valley University Hospital
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Kontakt:
- Gamal Abdelhamid Alsagheer, Professor
- Telefonnummer: +201062487020
- E-mail: alsagheer@med.svu.edu.eg
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Kontakt:
- Omar Mohamed El-Saghir, Assist.Prof
- Telefonnummer: +201095421734
- E-mail: Omarelsoqier1983@med.svu.edu.eg
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Children aged 1 to 18 years .
- Presence of a renal stone ≤2 cm in maximum diameter (single or multiple).
- Stone located in the renal pelvis and/or calyces.
- Normal renal function (based on age-adjusted serum creatinine and/or eGFR).
- No prior surgical intervention for the current stone episode.
Exclusion Criteria:
- Anatomical abnormalities of the urinary tract (e.g., ureteropelvic junction obstruction, horseshoe kidney).
- Bleeding disorders or uncorrected coagulopathy.
- Active urinary tract infection at the time of surgery.
- Patients with contraindications to general anesthesia.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Percutaneous Nephrolithotomy Group
About 30 child suffering from renal stone will undergo mini percutaneous nephrolithotomy
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to compare the efficacy and safety of retrograde intrarenal surgery (RIRS) versus mini-percutaneous nephrolithotomy (mini-PCNL) in the management of renal stones ≤2 cm in pediatric patients.
Andre navne:
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Aktiv komparator: Retrograde Intrarenal Surgery Group
About 30 child suffering from renal stone will undergo retrograde intrarenal surgery
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to compare the efficacy and safety of retrograde intrarenal surgery (RIRS) versus mini-percutaneous nephrolithotomy (mini-PCNL) in the management of renal stones ≤2 cm in pediatric patients.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Measure Stone-Free Rate:
Tidsramme: 6 months
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Defined as the absence of residual stones or the presence of clinically insignificant residual fragments (CIRF) <4 mm or absent and this will be better results, but if Clinical significant residual fragments > or Equal 4 mm may need Auxillary procedure Evaluation the patients after the operation by Stone-Free Rate as an indicator of surgical success.
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6 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Gamal Abdelhamid Alsagheer, Professor, Urology Department, Faculty of Medicine, South Valley University.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Pediatric Renal Stone
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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