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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01548196
First received: October 18, 2011
Last updated: March 7, 2012
Last verified: March 2012
History of Changes

October 18, 2011
March 7, 2012
February 2008
September 2011   (final data collection date for primary outcome measure)
  • Length of hospital stay [ Time Frame: until hospital discharge, about 2-3 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Loss of blood
Same as current
Complete list of historical versions of study NCT01548196 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Standard Percutaneous Nephrolithotomy Percutaneous Nephrolithotomy (PNL) Versus Tubeless PNL Versus Tubeless Stentless PNL
A Prospective, Randomized Controlled Pilot Study Of Standard Percutaneous Nephrolithotomy (PNL) Versus Tubeless PNL Versus Tubeless Stentless PNL

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Nephrolithotomy
Procedure: Standard Percutaneous nephrolithotomy
Percutaneous nephrolithotomy
  • standard percutaneous nephrostomy
    Standard PCN
    Intervention: Procedure: Standard Percutaneous nephrolithotomy
  • double-J ureteral stent,
    double-J ureteral stent,
    Intervention: Procedure: Standard Percutaneous nephrolithotomy
  • open-ended ureteral catheter
    open-ended ureteral catheter
    Intervention: Procedure: Standard Percutaneous nephrolithotomy
  • No Intervention: no nephrostomy or ureteral stent/catheter.
    no nephrostomy or ureteral stent/catheter.
    Intervention: Procedure: Standard Percutaneous nephrolithotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01548196
Pro00004138
Yes
Duke University
Duke University
Not Provided
Principal Investigator: Glenn Preminger, M.D. Duke University
Duke University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP