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

Completed · Phase 3

Conditions studied: Nephrolithotomy

In brief

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.

Key facts

Study ID

NCT01548196

Run by

Duke University

People needed

60

Starts

2008-02-01

Expected to finish

2011-09-01

Last updated by the study team

2015-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >18 years old
• Planned single tract percutaneous nephrolithotomy
• General anesthesia for percutaneous nephrolithotomy

You may not qualify if…

• 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

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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