Stepwise Shock Wave Lithotripsy in Pediatric Urolithiasis

TC Erciyes University

Status: Completed

Conditions: Pediatric Urinary Lithiasis

Treatments: Procedure: Shock wave lithotripsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01807260

stepwise0946

Details and patient eligibility

About

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

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 12 months to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The patients with pediatric urinary lithiasis.

Exclusion criteria

Resistant urinary tract infections Coagulopathies Anatomically obstructed urinary system

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

conventional Shock wave lithotripsy group

Active Comparator group

Description:

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.

Treatment:

Procedure: Shock wave lithotripsy

stepwise Shock wave lithotripsy group

Active Comparator group

Description:

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.

Treatment:

Procedure: Shock wave lithotripsy