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

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT01548196
Collaborator
(none)
60
Enrollment
1
Location
4
Arms
43
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Standard Percutaneous nephrolithotomy
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Feb 1, 2008
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Sep 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Other: standard percutaneous nephrostomy

Standard PCN

Procedure: Standard Percutaneous nephrolithotomy
Percutaneous nephrolithotomy
Other: double-J ureteral stent,

double-J ureteral stent,

Procedure: Standard Percutaneous nephrolithotomy
Percutaneous nephrolithotomy
Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Length of hospital stay [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

  2. Change in CBC and Chemistry Panel [at time of hospital discharge, about 2-3 days]

    Loss of blood

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Duke University Medical Center Durham North Carolina United States 27710

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Glenn Preminger, M.D., Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT01548196
Other Study ID Numbers:
  • Pro00004138
First Posted:
Mar 8, 2012
Last Update Posted:
Mar 17, 2015
Last Verified:
Mar 1, 2012
Keywords provided by Duke University
nephrolithotomy

Study Results

No Results Posted as of Mar 17, 2015