A Prospective, Randomized Controlled Pilot Study Of Standard Percutaneous Nephrolithotomy (PNL) Versus Tubeless PNL Versus Tubeless Stentless PNL
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Nephrolithotomy
- Sponsor
- Duke University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Length of hospital stay
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Length of hospital stay
Time Frame: 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
Time Frame: at time of hospital discharge, about 2-3 days
Loss of blood