The purpose of this study is to determine the efficacy of RetroPerc® in obtaining renal access for percutaneous nephrolithotomy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
this will consist of one visit to a urologist for retrograde nephrostomy placement using a Retroperc device with lithotomy performed in the same visit and follow up at 4 weeks and 6 months.
this will consist of two visits, first to the interventional radiologist for antegrade nephrostomy placement followed by another visit to the urologist for lithotomy with follow up at 4 weeks and 6 months
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Treatment efficacy as measured by the time taken from diagnosis to nephrostomy access
Time frame: end of procedure (about 4-8 weeks from diagnosis)
Treatment efficacy as measured by total time of access operation.
Time frame: end of procedure( about 90 minutes after start of procedure)
Treatment efficacy as measured by total time of access operation fluoroscopy
Time frame: end of procedure( about 90 minutes after start of procedure)
Treatment efficacy as measured by total time of lithotomy operation
Time frame: end of procedure(about 3 hours after start of procedure)
Treatment efficacy as measured by total time of lithotomy operation fluoroscopy
Time frame: (end of procedure)about 3 hours after start of procedure
Treatment efficacy as measured by length of post-operative hospital stay
Time frame: 24 hours after procedure
Number of patients that are stone free
stone free is defined as \<2mm on non-contrast computed tomography
Time frame: 6-12 weeks after procedure
Number of patients with symptom free survival as defined as lack of flank pain
Time frame: 6-12 weeks after procedure
Number of patients with symptom free survival as defined as lack of presence of urinary or gastrointestinal symptoms,
Time frame: 6-12 weeks after procedure
Number of patients with symptom free survival as defined as lack of limitations to work
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Time frame: 6-12 weeks after procedure
Number of patients with symptom free survival as defined as lack of limitations to social or daily activities.
Time frame: 6-12 weeks after procedure
Number of patients with nephrostomy access adequate for stone treatment
Time frame: end of procedure( abut 3 hours from start of procedure)
Number of patients with normal vital signs
Time frame: end of procedure( abut 3 hours from start of procedure)
Number of patients with normal laboratory values
laboratory values include complete metabolic panel and urinalysis
Time frame: 24 hours after procedure
Number of patients with an infection rate which is defined as a positive culture within the study time period
Time frame: 6-12 weeks after procedure
Number of patients that require pain medication (defined as discharge with an opioid prescription).
Time frame: 6-12 weeks after procedure