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Flexible ureteroscopy is a recent procedure to treat renal stone. Extracorporeal shockwave lithotripsy was the gold standard treatment for calculi between 5 and 20 mm. In literature, the two procedures are available to treat these stones with a good stone free rate. There is no prospective randomized study comparing these two treatments. Our study will define with a good level of evidence which technique is the best with regard to the stone free rate, secondary procedure rate and adverse effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extracorporeal shockwave lithotripsy | Active Comparator | stone treatment using electroconductive technology |
|
| Flexible ureteroscopy | Active Comparator | intra renal retrograde surgery with or without laser and stone extraction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| flexible ureteroscopy | Procedure | Flexible ureteroscopy will be use for 120 min max to treat renal stone. Laser, access sheath, baskets can be use to perform the technique. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stone free rate | Rate of stone free patient or patient with residual fragment ≤ 3 mm, 3 months after the treatment evaluated, will be compare. This outcome is measured with a tomodensitometry and compares with pre treatment exams. | Three months |
| Measure | Description | Time Frame |
|---|---|---|
| Stone free rate in weight's sub group | Each arm wil be divise in 3 sub group based on body mass index (20 to 25, 25 to 30, 30 to 35). We'll compare rate of efficacity in each sub group | 3 months |
| Stone free rate in sub group depending on stone diameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier Martin, PhD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'urologie, Hôpital Edouard Herriot | Lyon | 69 003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25640027 | Result | Ravier E, Abid N, Ruffion A, Fassi-Fehri H, Buron C, Ganne C, Mallet A, Martin X. [Effectiveness of flexible ureteroscopy versus extracorporeal shock wave lithotripsy for kidney stones treatment]. Prog Urol. 2015 Apr;25(5):233-9. doi: 10.1016/j.purol.2015.01.005. Epub 2015 Jan 29. French. |
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| ID | Term |
|---|---|
| D002137 | Calculi |
| ID | Term |
|---|---|
| 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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| extracorporeal shockwave lithotripsy | Procedure | The lithotriptor is use with 1,1 Hz frequency and stop when patient get 1000 joules of energy or if there is a problem with tolerance of this treatment or if stone is broken |
|
Each arm wil be divise in 3 sub group based on calculi diameter (5 to 10mm, 10 to 15 and 15 to 20). We'll compare rate of efficacity in each sub group |
| 3 months |
| Secondary procedure rate | In each arm will be evaluate rate of secondary procedure needed to have the best stone free rate | 3 months |
| Serious and non serious adverse events | In each arm will be evaluate rate of adverse event, type, severity. | 3 months |