Stepwise Shock Wave Lithotripsy in Pediatric Urolithiasis

Study Overview
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Brief Summary
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To evaluate and compare the results of conventional and stepwise shock wave lithotripsy treatment modalities in pediatric urinary lithiasis.

Detailed Description
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Between March 2008 and February 2012, 81 patients were randomized and included in this study. Shock wave lithotripsy was performed by using a Dornier Compact Delta instrument. Localizations of radiopaque and non-opaque stones were estimated by using flouroscopy and ultrasonography, respectively. Treatment energy was set on 13 kV in the conventional group. In the stepwise group, treatment energy was initially set on 10 kV and gradually increased up to 13 kV per 250 shocks. The maximum numbers of shocks in both groups were limited to 3000. Patients were followed up with 15 days interval. In each visit, patients were respectively questioned for pain, hematuria and history of stone passage. In case of treatment failure, shock wave lithotripsy was repeated.

Official Title
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STEPWISE SHOCK WAVE LITHOTRIPSY IN PEDIATRIC UROLITHIASIS: A COMPARATIVE STUDY.

Conditions
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Pediatric Urinary Lithiasis

Intervention / Treatment
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* Procedure: Shock wave lithotripsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients with pediatric urinary lithiasis. Exclusion Criteria: Resistant urinary tract infections Coagulopathies Anatomically obstructed urinary system

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional Shock wave lithotripsy group<br>All procedures were performed under continu¬ous intravenous sedo-analgesia (using a combi-nation of ketamine 1 mg/kg and propofol 0,5-1 mg/kg) with fluoroscopic or ultrasonograpic imaging in a supine position. Shock wave number was limited to a maximum of 3000 waves/session. In the conventional group the voltage was only 13 kV. The stone burden was defined as the stone area that was calculated by multiply¬ing the largest length and width of the individual stones measured from the abdominal plain X-ray. | Procedure: Shock wave lithotripsy<br>* All procedures were performed under continuous intravenous sedo-analgesia (using a combination of ketamine 1 mg/kg and propofol 0,5-1 mg/kg) with fluoroscopic or ultrasonograpic imaging in a supine position. Shock wave lithotrpisy was poerformed with a Dornier Compact Delta lithotripter (Dornier Medtech, Germany). Shock wave number was limited to a maximum of 3000 waves/session. In the conventional group the voltage was only 13 kV. The stone burden was defined as the stone area that was calculated by multiplying the largest length and width of the individual stones measured from the abdominal plain X-ray.<br>|
| Active Comparator: stepwise Shock wave lithotripsy group<br>All procedures were performed under continu¬ous intravenous sedo-analgesia (using a combi-nation of ketamine 1 mg/kg and propofol 0,5-1 mg/kg) with fluoroscopic or ultrasonograpic imaging in a supine position. Shock wave number was limited to a maximum of 3000 waves/session. In the stepwise group, the voltage was started at 10 kV and increased stepwise (every 250 shock waves) to 13 kV. The stone burden was defined as the stone area that was calculated by multiply¬ing the largest length and width of the individual stones measured from the abdominal plain X-ray. | Procedure: Shock wave lithotripsy<br>* All procedures were performed under continuous intravenous sedo-analgesia (using a combination of ketamine 1 mg/kg and propofol 0,5-1 mg/kg) with fluoroscopic or ultrasonograpic imaging in a supine position. Shock wave lithotrpisy was poerformed with a Dornier Compact Delta lithotripter (Dornier Medtech, Germany). Shock wave number was limited to a maximum of 3000 waves/session. In the conventional group the voltage was only 13 kV. The stone burden was defined as the stone area that was calculated by multiplying the largest length and width of the individual stones measured from the abdominal plain X-ray.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone burden on plain X-ray. | The stone burden was defined as the stone area that was calculated by multiplying the largest length(cm)and width (cm)of the individual stones measured from the abdominal plain X-ray. To detect fragmentation of the stone and necessity of re-treatment a plain film were used during control. Stone clearance was assessed at three months. Stone-free state was defined as the absence of stone fragments on a good quality plain X-ray. Clinical success was considered if the residual fragments were 2-3 mm or less in asymptomatic patients. | Three months. |