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Ultraslow full-power SWL versus slow power-ramping SWL in stones with high attenuation value
To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultraslow shock wave lithotripsy (SWL) | Active Comparator | SWL at ultraslow rate of 30 SW/min. Power ramping at the first 100 SW from 6 to 18 kv followed by safety pause for two minutes then power ramping from 18 to 22kv during the second 100 SW followed by safety pause for another two minutes. The rest of the session at 22kv (full power). |
|
| Slow power-ramping SWL | Active Comparator | SWL at a slow rate of 60 SW/min. Power ramping from 6 - 10 kv during the first 500 SW then from 11 - 14 kv during the second 500 SW then from 15 - 18 kv during the following 500 SW then from 19 - 22 kv during the remaining 1000 - 1500 SW. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SWL | Procedure | Shock wave lithotripsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| stone free rate | Complete clearance of stones in addition to clinically insignificant residual fragments | 3 months following last session of SWL |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Comparison of complications in both groups | 1 year following last session of SWL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmad Aref Al-Dessoukey, Ass. Prof. | Beni-Suef University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni-Suef Hospitals | Banī Suwayf | Outside U.S./Canada | Egypt |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 1, 2015 | Dec 3, 2018 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |