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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Mostafa Mahmoud Rashed Ali, M.D
- Telefonnummer: +20111049435
- E-post: Mostafarashed2222@gmail.com
Studera Kontakt Backup
- Namn: Atef Fathi Ali, professor
- Telefonnummer: +201099051714
- E-post: Ateffathi2010@yahoo.com
Studieorter
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South Valley
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Qina, South Valley, Egypten
- Rekrytering
- South Valley University Hospital
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Kontakt:
- Gamal Abdelhamid Alsagheer, Professor
- Telefonnummer: +201062487020
- E-post: alsagheer@med.svu.edu.eg
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Kontakt:
- Omar Mohamed El-Saghir, Assist.Prof
- Telefonnummer: +201095421734
- E-post: Omarelsoqier1983@med.svu.edu.eg
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / 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.
Andra namn:
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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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Measure Stone-Free Rate:
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Gamal Abdelhamid Alsagheer, Professor, Urology Department, Faculty of Medicine, South Valley University.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- Pediatric Renal Stone
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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