Clinical Trials Directory

Trials / Completed

CompletedNCT00873054

Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy

Status
Completed
Phase
Study type
Observational
Enrollment
32 (actual)
Sponsor
CAMC Health System · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Accepted

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.

Detailed 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.

Conditions

Timeline

Start date
2008-10-01
Primary completion
2010-10-01
Completion
2011-01-01
First posted
2009-04-01
Last updated
2014-02-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00873054. Inclusion in this directory is not an endorsement.