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Completed

NCT Number: NCT01548196

Standard Percutaneous Nephrolithotomy 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.

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Key information

Conditions

Nephrolithotomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard percutaneous nephrolithotomy

Procedure

Percutaneous nephrolithotomy

Primary outcomes

  1. 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

  2. Change in CBC and Chemistry Panel

    Time frame: at time of hospital discharge, about 2-3 days

    Loss of blood

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Mar 8, 2012
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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