Status:
UNKNOWN
Ambulatory Versus Inpatient Percutaneous Nephrolithotomy
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Queen's University
Conditions:
Kidney Calculi
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of the study is to determine if ambulatory tubeless PCNL is safe and effective compared to inpatient PCNL with a nephrostomy tube.
Detailed Description
One in eight human beings will develop kidney stones during their lifetime. Of these, roughly 20% require surgery. Percutaneous nephrolithotomy (PCNL) is the standard minimally invasive surgical proce...
Eligibility Criteria
Inclusion
- Scheduled for PCNL who agree to be included in the study
- Age 18 years or more
- Absence of renal anatomic abnormalities
- Patients undergoing bilateral procedures or those with pre-operative indwelling ureteral stents or nephrostomy tubes will be included
Exclusion
- Pre-operative:
- Age \<18
- Pregnancy
- Positive urine culture within 3 weeks
- Bleeding disorder
- Presence of renal anatomic abnormalities
- Solitary kidney
- Need for admission based on comorbidities determined by anesthesiologist
- Intra-operative:
- Significant ureteral or pelvicalyceal injury
- Significant intraoperative hemorrhage
- Post-operative:
- Temperature \>100.4 Fahrenheit
- Hemodynamic instability (defined as 2 of 3: heart rate \>90 beats per minute, respiratory rate \>20 breaths per minute, systolic blood pressure \<90mmHg, or drop in systolic blood pressure \>40mmHg)
- Hemoglobin drop of \> 3 g/dL compared to pre-operative bloodwork
- Transfusion of blood products
- Pneumothorax or hemothorax on chest X ray
- Uncontrolled nausea, vomiting, or pain
Key Trial Info
Start Date :
January 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04690010
Start Date
January 8 2022
End Date
December 30 2024
Last Update
December 20 2023
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143