Nephrolithotomy
Conditions
Keywords
nephrolithotomy
Brief summary
The purpose of the study is to assess and compare the efficacy and morbidity standard percutaneous nephrolithotomy with tubeless PNL. A total of approximately 60 patients will be enrolled. Patients will be randomized to one of four groups: standard percutaneous nephrostomy, double-J ureteral stent, open-ended ureteral catheter and no nephrostomy or ureteral stent/catheter. Primary Outcome Measures will include length of procedure and estimated blood loss. Post-operative analgesic use (both parenteral and oral), pain scores, time to ambulation, time to oral intake, and pain scores will also be recorded. Time to nephrostomy tube removal, external ureteral and Foley catheter removal and patient discharge from the hospital will also be recorded. Incidence and type of post-operative complications will also be recorded.
Interventions
Percutaneous nephrolithotomy
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years old * Planned single tract percutaneous nephrolithotomy * General anesthesia for percutaneous nephrolithotomy
Exclusion criteria
* Age\<18 years old * Known residual calculi at the end of the procedure * Significant hemorrhage during procedure * Bleeding disorder (This does not include patients taking anti-coagulants as these are stopped prior to surgery.) * Prisoners * Inability to give informed consent * Pregnant females * Solitary kidney * Transplant kidney * Pleural effusion during procedure requiring drainage * Perforation of renal collecting system during procedure * Incomplete stone clearance * Chronic pain syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | until hospital discharge, about 2-3 days | measuring days of hospital stay after procedure, and the effect that the location of the puncture has on the length of hospital stay |
| Change in CBC and Chemistry Panel | at time of hospital discharge, about 2-3 days | Loss of blood |
Countries
United States
Outcome results
None listed