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.