Stepwise Shock Wave Lithotripsy in Pediatric Urolithiasis

NCT01807260 | Completed

• 1 other identifier: stepwise0946
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pediatric Urinary Lithiasis

Outcome Measures

Primary Outcomes (1)

• 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.

Other Outcomes (2)

• Degree and presence of hydronephrosis.

  Three months

• Stone burden on spiral computed tomography

  Three months

Study Arms (2)

conventional Shock wave lithotripsy group

ACTIVE COMPARATOR

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

stepwise Shock wave lithotripsy group

ACTIVE COMPARATOR

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

Interventions

Shock wave lithotripsy PROCEDURE

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.

conventional Shock wave lithotripsy group; stepwise Shock wave lithotripsy group

Eligibility Criteria

• Age: 12 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The patients with pediatric urinary lithiasis.

You may not qualify if:

• Resistant urinary tract infections Coagulopathies Anatomically obstructed urinary system

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Department of Urology, Erciyes University Medical Faculty,

Kayseri, Talas, 38280, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 16868680 RESULT

Study Officials

• Deniz Demirci, Prof.

  Department of Urology, Erciyes University Medical faculty,

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: March 8, 2013
• Study Start: March 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 8, 2013

Record last verified: 2013-03

Locations

TU (1)