An observational study in Kidney Stone, sponsored by The International Alliance of Urolithiasis. Status unknown. Open to participants aged Up to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-30.
Sponsored by The International Alliance of Urolithiasis · Observational
ESWL and PNL are the two treatment modalities for kidney stones greater than 20 mm in the pediatric population. ESWL is non-invasive, does not require anesthesia and inexpensive, but its success rate may be lower, and require multiple treatment sessions. On the contrary, PNL has a higher success rate, does not require multiple sessions but is an invasive method. Compared to standard PNL, miniaturized PNL systems have been shown to decrease complications with comparable success rates. SMP is a unique miniaturized PNL system with integrated active irrigation and suction systems. The current literature lacks studies comparing SMP and ESWL prospectively in the pediatric population. In this study, the effectiveness, reliability, and reusability of ESWL and SMP will be compared.
To compare the success and complication rates of super-mini-percutaneous nephrolithotomy (SMP) and Extracorporeal Shock Wave Lithotripsy (ESWL) for the treatment of renal stones ≥20 mm in children.An international multicentre, prospective, observational study. Pediatric cases with renal Stones ≥20 mm who undergo ESWL or SMP will be evaluated and compared proespectively. The total number of departments planned to be included in the study is 10 and the number of cases is 180.
598 studies on the registry are indexed under Kidney Calculi; 163 are open to participants now.
This study's planned enrollment of 250 is above the median of 144 across 110 observational studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →This is the only study on the registry with The International Alliance of Urolithiasis as lead sponsor.
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Pediatric patients undergoing SWL and SMP
Exclusion Criteria:
Patients undergo SMP
Procedure: Super-mini percutaneous nephrolithotomy (SMP)
Patients undergo ESWL
Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)
SMP will be performed under general anesthesia in prone/supine position. Renal puncture will be performed under ultrasound/fluoroscopy guidance based on the preference of the participating surgeon. Tracts will be dilated to 14 Fr. Stone fragmentation will be performed with holmium laser and fragments will be extracted with the active suction system. For the exit strategy, placement of a nephrostomy tube or JJ stent will be decided by the participating surgeon.
ESWL will be performed under sedation/analgesia, shock wave lithotripsy parameters will be determined based on the device and the settings of local center. For patients requiring multiple sessions, maximum 3 (or more) sessions will be allowed. Ureteral stenting prior to ESWL will be performed based on the decision of the participating center.
Stone free rate
Stone clearance on the computed tomography (2mm thickness)
Time frame: 3-months
blood loss
Number of participants requiring blood transfusion after the procedure
Time frame: Postoperative day 1
auxiliary procedures
Number of patients requiring additional auxiliary procedures such as second look PCNL, SWL, Ureteroscopy
Time frame: Postoperative month 3
hospital stay
From date of admission until the date of discharge,length of hospital stay
Time frame: Postoperative month 3
complications
Rate of postoperative complications using the Clavien-Dindo system
Time frame: Postoperative month 3
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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