Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in 5 to 20 mm Renal Calculi, Efficacity Prospective Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Extracorporeal Shockwave Lithotripsy, Flexible Ureteroscopy
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Stone free rate
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient with 5 to 20 mm renal stone
- •Age ≥ 18 years old
- •Patient agreement signed
- •BMI \< 35
- •Contraception
Exclusion Criteria
- •Pregnancy
- •Severe musculoskeletal deformities
- •Renal artery or aorta aneurysm
- •Pacemaker
- •Anesthesia contra indication
- •Psychiatric trouble or law protection
Outcomes
Primary Outcomes
Stone free rate
Time Frame: Three months
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.
Secondary Outcomes
- Stone free rate in weight's sub group(3 months)
- Stone free rate in sub group depending on stone diameters(3 months)
- Serious and non serious adverse events(3 months)
- Secondary procedure rate(3 months)