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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05697341
Other study ID # YRS0001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date June 1, 2022

Study information

Verified date January 2023
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Nephrolithiasis is the third most common disease of the urinary tract. As minimally invasive technologies develop, shock wave lithotripsy (SWL), retrograde intrarenal surgery (RIRS), and percutaneous nephrolithotomy (PCNL) are different surgeries to treat renal stones. Aim of the Study is to compare results, safety and outcome of Ultra mini PCNL versus stented extracorporeal shock wave lithotripsy (SWL) for the management of renal calculi from 10 - 20 mm. Patients were randomized to either Ultra-Mini-Percutaneous nephrolithotomy group or stented SWL group via the closed envelope method. Patient data was collected preoperatively, immediately postoperatively and 2 and 4 weeks postoperatively to assess operative time, hospital stay, complications regarding fever, hematuria and need for blood transfusion, residual stones and need for retreatment.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Ultra-Mini-PCNL
treatment to extract or disintegrate renal stones
Stented SWL
treatment to disintegrate renal stones in the presence of a JJ

Locations

Country Name City State
Egypt Ain Shams University, Faculty of medicine Cairo Abbassia

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Bozzini G, Verze P, Arcaniolo D, Dal Piaz O, Buffi NM, Guazzoni G, Provenzano M, Osmolorskij B, Sanguedolce F, Montanari E, Macchione N, Pummer K, Mirone V, De Sio M, Taverna G. A prospective randomized comparison among SWL, PCNL and RIRS for lower calyceal stones less than 2 cm: a multicenter experience : A better understanding on the treatment options for lower pole stones. World J Urol. 2017 Dec;35(12):1967-1975. doi: 10.1007/s00345-017-2084-7. Epub 2017 Sep 5. — View Citation

Gao XS, Liao BH, Chen YT, Feng SJ, Gao R, Luo DY, Liu JM, Wang KJ. Different Tract Sizes of Miniaturized Percutaneous Nephrolithotomy Versus Retrograde Intrarenal Surgery: A Systematic Review and Meta-Analysis. J Endourol. 2017 Nov;31(11):1101-1110. doi: 10.1089/end.2017.0547. Epub 2017 Oct 30. — View Citation

Kim CH, Chung DY, Rha KH, Lee JY, Lee SH. Effectiveness of Percutaneous Nephrolithotomy, Retrograde Intrarenal Surgery, and Extracorporeal Shock Wave Lithotripsy for Treatment of Renal Stones: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2020 Dec 30;57(1):26. doi: 10.3390/medicina57010026. — View Citation

Skolarikos A, Straub M, Knoll T, Sarica K, Seitz C, Petrik A, Turk C. Metabolic evaluation and recurrence prevention for urinary stone patients: EAU guidelines. Eur Urol. 2015 Apr;67(4):750-63. doi: 10.1016/j.eururo.2014.10.029. Epub 2014 Nov 20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Stone-free status The complete stone clearance or presence of clinically insignificant residual fragments (<4 mm) 2 or 4 weeks after the final procedure was regarded as stone-free at 2 or 4 weeks after ultra-mini-PCNL or stented SWL
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