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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00873054
Other study ID # 08-08-2078
Secondary ID
Status Completed
Phase N/A
First received March 31, 2009
Last updated January 30, 2014
Start date October 2008
Est. completion date January 2011

Study information

Verified date January 2014
Source CAMC Health System
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The investigators main hypothesis is that the stone free rate will be much higher (95%) in patients treated with PCNL than patients treated with ESWL where stone free rate is (60%) to determine which treatment is safe and prevent less stone recurrence.


Description:

Extracorporeal shock wave lithotripsy is preferred for small stones less than 10 mm in size. Percutaneous nephrolithotomy is the standard therapy used for large kidney stones greater than 20 millimeters or stones in the lower kidney. For moderate sized kidney stone (10-20 mm),currently the options for treatment include both methods. However, no studies have proven that one procedure is better than the other. So, we will compare both the procedures for breaking the kidney stone. Our main outcome measures will be the stone-free status after the procedure. Other outcome measures are assessment of morbidity associated with use of the procedures i.e. any minor or major complications within 3 months of initial treatment. Patient will be assessed for infection at post-operative office visits to include a basic urinalysis only if they have systemic indicators of infection (fever, dysuria, frequency, etc.). Pain will be monitored with the scale of 0-10 points. Also we will review of stone density on Computerized Tomography (CT) scans and the effect this has on success of both procedures. We hope with PCNL stone-free rates will be minimum with minimal morbidity and ultimately improve patient care.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date January 2011
Est. primary completion date October 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Patients of both sex with age greater than 18 years to 90 years

- Stone burden between 10 and 20 mm diagnosed by CT scan

- Patient must be agreeable to randomization between shock wave lithotripsy and percutaneous stone removal

Exclusion Criteria:

- Patients with bleeding diathesis or taking anti-platelet or anti-coagulant medication

- Patients who are pregnant based on routine pre-operative pregnancy testing

- Patients with skin to stone size greater than 12 cm (measured routinely on CT scan)

- Patients with either Horseshoe kidney, transplant kidney or a solitary kidney

- Patients with ureteral calculi

- Patients with stone size of < 10 mm and > 20 mm

- Ureteropelvic junction obstruction

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Urology Center of Charleston Charleston West Virginia

Sponsors (1)

Lead Sponsor Collaborator
CAMC Health System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary objective of this study is to compare the stone-free status after Extracorporeal Shock Wave Lithotripsy (ESWL) and Percutaneous Nephrolithotomy (PCNL) for kidney stones 10-20 mm in size. Within 3 months of enrollment No
Secondary A secondary objective is to assess the morbidity associated with use of the procedures i.e. any minor or major complications within 3 months of initial treatment. Within 3 months of enrollment No
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