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

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Duke University

Status and phase

Completed
Phase 3

Conditions

Nephrolithotomy

Treatments

Procedure: Standard Percutaneous nephrolithotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01548196
Pro00004138

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 4 patient groups

standard percutaneous nephrostomy
Other group
Description:
Standard PCN
Treatment:
Procedure: Standard Percutaneous nephrolithotomy
double-J ureteral stent,
Other group
Description:
double-J ureteral stent,
Treatment:
Procedure: Standard Percutaneous nephrolithotomy
open-ended ureteral catheter
Other group
Description:
open-ended ureteral catheter
Treatment:
Procedure: Standard Percutaneous nephrolithotomy
no nephrostomy or ureteral stent/catheter.
No Intervention group
Description:
no nephrostomy or ureteral stent/catheter.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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