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Clinical Trials/NCT01807260
NCT01807260
Completed
Not Applicable

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

TC Erciyes University1 site in 1 country81 target enrollmentMarch 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Urinary Lithiasis
Sponsor
TC Erciyes University
Enrollment
81
Locations
1
Primary Endpoint
Stone burden on plain X-ray.
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
June 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Abdullah Demirtas

Assistant Professor

TC Erciyes University

Eligibility Criteria

Inclusion Criteria

  • The patients with pediatric urinary lithiasis.

Exclusion Criteria

  • Resistant urinary tract infections Coagulopathies Anatomically obstructed urinary system

Outcomes

Primary Outcomes

Stone burden on plain X-ray.

Time Frame: Three months.

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.

Study Sites (1)

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