Renal Calculi Clinical Trial
Official title:
External Physical Vibration Lithecbole(EPVL) Contrast With the Traditional Row of Stone Effect After Retrograde Intrarenal Surgery(RIRS): A Multi-center Prospective Randomized Controlled Trial
The treatment of renal calculus by retrograde intrarenal surgery(RIRS) isn't able to eliminate stone completely, hastening fragments clearance just only rely on traditional expulsive methods such as high fluid intake ,increasing physical activity, medical expulsive therapy and changing body position. Therefore, researchers purpose to evaluate the effectiveness of external physical vibration lithecbole(EPVL) in treatment of residual fragments after RIRS by prospective study of clinical trial, which will improve stone-free rate of residual fragments and benefit more patients.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | March 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Age of 18-65 years; 2. The imaging demonstrate the presence of residual fragments in 1 week after RIRS; 3. Renal or upper ureteral calculus; 4. There's no urinary tract obstruction below stones, and stones didn't cause complete urinary tract obstruction; 5. Stones are fragmented successfully on single session of RIRS, and the diameter of any of fragments is less than 4mm; 6. Normal renal function. Exclusion Criteria: 1. Couldn't tolerate EPVL; 2. Urinary tract anomalies, stricture or obstruction; 3. Calculus in diverticulum; 4. Severe hydronephrosis; 5. Combined with acute urinary tract infection; 6. Coagulation abnormalities; |
Country | Name | City | State |
---|---|---|---|
China | Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Guangzhou Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from stone free rate(SFR) with different follow-up periods | Primary SFR is assessed by abdominal plain film (KUB)at2,3,5 week after operation. Stone-free status are defined as either the absence of any residual stone fragments. | return hospital respectively in 2,3 and 5 week after RIRS | |
Secondary | extracorporeal physical vibration complications | Complication is defined as any adverse event occurred | return hospital respectively in 2 ,3 and 5 weeks after RIRS |
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