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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
  Purpose

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.


Condition Intervention Phase
Nephrolithotomy
 Procedure: Standard Percutaneous nephrolithotomy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Controlled Pilot Study Of Standard Percutaneous Nephrolithotomy (PNL) Versus Tubeless PNL Versus Tubeless Stentless PNL

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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


Enrollment: 60
Study Start Date: February 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
standard percutaneous nephrostomy
Standard PCN
 Procedure: Standard Percutaneous nephrolithotomy
Percutaneous nephrolithotomy
double-J ureteral stent,
double-J ureteral stent,
 Procedure: Standard Percutaneous nephrolithotomy
Percutaneous nephrolithotomy
open-ended ureteral catheter
open-ended ureteral catheter
 Procedure: Standard Percutaneous nephrolithotomy
Percutaneous nephrolithotomy
No Intervention: no nephrostomy or ureteral stent/catheter.
no nephrostomy or ureteral stent/catheter.
 Procedure: Standard Percutaneous nephrolithotomy
Percutaneous nephrolithotomy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Perforation of renal collecting system during procedure
  • Incomplete stone clearance
  • Chronic pain syndrome
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548196

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Glenn Preminger, M.D. Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01548196     History of Changes
Other Study ID Numbers: Pro00004138
Study First Received: October 18, 2011
Last Updated: March 7, 2012
Health Authority: Institutional Review Board, USA:

Keywords provided by Duke University:
nephrolithotomy

ClinicalTrials.gov processed this record on May 16, 2013