The purpose of this study is to compare relevant clinical outcomes in patients requiring percutaneous nephrostomy for urolithiasis treatment between those who undergo an antegrade approach versus a retrograde approach and to determine which clinical characteristics predict success of lithotomy with anterograde or retrograde percutaneous nephrostomy approaches.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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