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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Super-Mini Percutaneous Nephrolithotomy | Patients undergo SMP |
| |
| Extracorporeal Shock Wave Lithotripsy | Patients undergo ESWL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Super-mini percutaneous nephrolithotomy (SMP) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Stone free rate | Stone clearance on the computed tomography (2mm thickness) | 3-months |
| Measure | Description | Time Frame |
|---|---|---|
| blood loss | Number of participants requiring blood transfusion after the procedure | Postoperative day 1 |
| auxiliary procedures | Number of patients requiring additional auxiliary procedures such as second look PCNL, SWL, Ureteroscopy |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients undergoing SWL and SMP
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|
| Extracorporeal Shock Wave Lithotripsy (ESWL) | Procedure | 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. |
|
| Postoperative month 3 |
| hospital stay | From date of admission until the date of discharge,length of hospital stay | Postoperative month 3 |
| complications | Rate of postoperative complications using the Clavien-Dindo system | Postoperative month 3 |
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008096 | Lithotripsy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D059708 | Ultrasonic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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