Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization for Pediatric Renal Stones.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Egymedicalpedia
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Lithotripsy or nephrolithotripsy by Shock waves
Study Overview
Brief Summary
Epidemiological studies have shown a progressive increase in the incidence of pediatric urolithiasis over the past few decades.
Detailed Description
Pediatric stone disease is considered endemic in developing nations including Turkey, Pakistan, and eastern countries. The introduction of SWL by Chaussy et al. in the early 1980s revolutionized the management of upper urinary tract calculus disease.
Reports of successful SWL in children were first published in 1986; then several reports showed safety, and stone-free rates comparable with those of adults. For successful SWL, accurate localization of the shock waves is performed by ultrasound (US) or fluoroscope (FS) to fully focus the shock waves on the stone
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 2 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children (2-16) years of age with radiopaque renal pelvic stones less than 20 mm
Exclusion Criteria
- •Previous percutaneous nephrolithotripsy at the same side.
- •Previous renal exploration for stones at the same side.
- •Positive urinary culture.
- •Calyceal stones
Outcomes
Primary Outcomes
Lithotripsy or nephrolithotripsy by Shock waves
Time Frame: from baseline to 3 months after the Lithotripsy date.
Incidence of success of Nephrolithotripsy by using Fluoroscopic shock waves or Ultrasonic shock waves in pediatric renal pelvic stones.
Secondary Outcomes
- Complications of shockwave lithotripsy(through study completion, an average of 1 year)