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Stepwise Shock Wave Lithotripsy in Pediatric Urolithiasis

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ClinicalTrials.gov Identifier: NCT01807260
Recruitment Status : Completed
First Posted : March 8, 2013
Last Update Posted : March 8, 2013
Sponsor:
Information provided by (Responsible Party):
Abdullah Demirtas, TC Erciyes University

Tracking Information
First Submitted Date  ICMJE February 28, 2013
First Posted Date  ICMJE March 8, 2013
Last Update Posted Date March 8, 2013
Study Start Date  ICMJE March 2008
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: March 6, 2013)
  • Degree and presence of hydronephrosis. [ Time Frame: Three months ]
    To detect obstruction in the system, ultrasonography was used during control.
  • Stone burden on spiral computed tomography [ Time Frame: Three months ]
    In case of non-opaque Stones, stone borden was evalusted with spinal computed tomography. Clinical success was considered if the residual fragments were 2-3 mm or less in asymptomatic patients.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Stepwise Shock Wave Lithotripsy in Pediatric Urolithiasis
Official Title  ICMJE STEPWISE SHOCK WAVE LITHOTRIPSY IN PEDIATRIC UROLITHIASIS: A COMPARATIVE STUDY.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pediatric Urinary Lithiasis
Intervention  ICMJE Procedure: Shock wave lithotripsy
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.
Study Arms  ICMJE
  • Active Comparator: conventional Shock wave lithotripsy group
    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.
    Intervention: Procedure: Shock wave lithotripsy
  • Active Comparator: stepwise Shock wave lithotripsy group
    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.
    Intervention: Procedure: Shock wave lithotripsy
Publications * Demirci D, Altiok E, Gülmez I, Ekmekçioğlu O, Poyrazoğlu HM. Stepwise shock wave lithotripsy: results of initial study for the treatment of urinary stones in childhood. Int Urol Nephrol. 2006;38(2):189-92.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2013)
81
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

The patients with pediatric urinary lithiasis.

Exclusion Criteria:

Resistant urinary tract infections Coagulopathies Anatomically obstructed urinary system

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01807260
Other Study ID Numbers  ICMJE stepwise0946
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abdullah Demirtas, TC Erciyes University
Study Sponsor  ICMJE TC Erciyes University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Deniz Demirci, Prof. Department of Urology, Erciyes University Medical faculty,
PRS Account TC Erciyes University
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP