Standard Percutaneous Nephrolithotomy Percutaneous Nephrolithotomy (PNL) Versus Tubeless PNL Versus Tubeless Stentless PNL

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized Controlled Pilot Study Of Standard Percutaneous Nephrolithotomy (PNL) Versus Tubeless PNL Versus Tubeless Stentless PNL

Conditions
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Nephrolithotomy

Intervention / Treatment
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* Procedure: Standard Percutaneous nephrolithotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: standard percutaneous nephrostomy<br>Standard PCN | Procedure: Standard Percutaneous nephrolithotomy<br>* Percutaneous nephrolithotomy<br>|
| Other: double-J ureteral stent,<br>double-J ureteral stent, | Procedure: Standard Percutaneous nephrolithotomy<br>* Percutaneous nephrolithotomy<br>|
| Other: open-ended ureteral catheter<br>open-ended ureteral catheter | Procedure: Standard Percutaneous nephrolithotomy<br>* Percutaneous nephrolithotomy<br>|
| No Intervention: no nephrostomy or ureteral stent/catheter.<br>no nephrostomy or ureteral stent/catheter. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | measuring days of hospital stay after procedure, and the effect that the location of the puncture has on the length of hospital stay | until hospital discharge, about 2-3 days | 
| Change in CBC and Chemistry Panel | Loss of blood | at time of hospital discharge, about 2-3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nephrolithotomy