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Clinical Trials/NCT01548196
NCT01548196
Completed
Phase 3

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

Duke University1 site in 1 country60 target enrollmentFebruary 2008
ConditionsNephrolithotomy

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.

Registry
clinicaltrials.gov
Start Date
February 2008
End Date
September 2011
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Study Sites (1)

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