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

March 12, 2015 updated by: Duke University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
until hospital discharge, about 2-3 days
Change in CBC and Chemistry Panel
Time Frame: at time of hospital discharge, about 2-3 days
Loss of blood
at time of hospital discharge, about 2-3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

October 18, 2011

First Submitted That Met QC Criteria

March 7, 2012

First Posted (Estimate)

March 8, 2012

Study Record Updates

Last Update Posted (Estimate)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 12, 2015

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00004138

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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