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Stepwise Shock Wave Lithotripsy in Pediatric Urolithiasis

Primary Purpose

Pediatric Urinary Lithiasis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Shock wave lithotripsy
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Urinary Lithiasis

Eligibility Criteria

12 Months - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The patients with pediatric urinary lithiasis.

Exclusion Criteria:

Resistant urinary tract infections Coagulopathies Anatomically obstructed urinary system

Sites / Locations

  • Department of Urology, Erciyes University Medical Faculty,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

conventional Shock wave lithotripsy group

stepwise Shock wave lithotripsy group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 28, 2013
Last Updated
March 6, 2013
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT01807260
Brief Title
Stepwise Shock Wave Lithotripsy in Pediatric Urolithiasis
Official Title
STEPWISE SHOCK WAVE LITHOTRIPSY IN PEDIATRIC UROLITHIASIS: A COMPARATIVE STUDY.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Urinary Lithiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional Shock wave lithotripsy group
Arm Type
Active Comparator
Arm 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.
Arm Title
stepwise Shock wave lithotripsy group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Shock wave lithotripsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stone burden on plain X-ray.
Description
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.
Time Frame
Three months.
Other Pre-specified Outcome Measures:
Title
Degree and presence of hydronephrosis.
Description
To detect obstruction in the system, ultrasonography was used during control.
Time Frame
Three months
Title
Stone burden on spiral computed tomography
Description
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.
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patients with pediatric urinary lithiasis. Exclusion Criteria: Resistant urinary tract infections Coagulopathies Anatomically obstructed urinary system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deniz Demirci, Prof.
Organizational Affiliation
Department of Urology, Erciyes University Medical faculty,
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Urology, Erciyes University Medical Faculty,
City
Kayseri
State/Province
Talas
ZIP/Postal Code
38280
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
16868680
Citation
Demirci D, Altiok E, Gulmez I, Ekmekcioglu O, Poyrazoglu 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. doi: 10.1007/s11255-005-4971-x.
Results Reference
result

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Stepwise Shock Wave Lithotripsy in Pediatric Urolithiasis

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