FloSeal Tubeless Exit Versus Cope Loop Nephrostomy Versus Fascial Stitch Following Percutaneous Nephrolithotripsy

Brief Summary

Official Title: “Prospective Randomized Trial of Floseal Tubeless Exit vs. Cope Loop Nephrostomy vs. Fascial Stitch Following Percutaneous Nephrolithotripsy”

The patient will be asked to participate in a research project designed to determine the best way to prevent bleeding and promote patient comfort after having kidney stones removed. Two standard methods for ending the surgery are being compared to a newer method. In one standard method, the patient will have a tube draining urine from the kidney after the procedure. This tube may also prevent bleeding from the kidney. In another standard method the patient will have a tube left internally that drains urine from the kidney to the bladder and a stitch will be used to close the incision and deeper tissues in the back. In the third potential option, a tube would be left internally to drain urine from the kidney to the patient's bladder and the surgical site would be filled with a clot promoting agent (FloSeal) which is a FDA approved agent specifically formulated to stop bleeding during surgical procedures.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
  • Study Primary Completion Date: January 2014

Interventions Used in this Clinical Trial

  • Procedure: Floseal
    • Bioglue that seals the kidney
  • Procedure: Cope Loop
    • Nephrostomy tube for fluid drainage from the kidney
  • Procedure: Fascial Stitch
    • Stitch that closes the kidney

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
    • Floseal
  • Active Comparator: 2
    • Cope-Loop/Nephrostomy Tube
  • Active Comparator: 3
    • Fascial Stitch

Outcome Measures for this Clinical Trial

Primary Measures

  • To determine which method of treatment causes the least pain to the patient.
    • Time Frame: one month
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • The patient has kidney stones that require treatment (tx) with percutaneous stone removal
  • 18 years of age or over

Exclusion Criteria

  • Patient mentally impaired, have a chronic pain syndrome or disorder, or any condition that might alter the sensation of pain
  • Patient taking coumadin
  • Pre-existing percutaneous nephrostomy

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • University of California, Irvine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Victor Huynh, Urology Contact – University of California, Irvine
  • Overall Official(s)
    • Michael K Louie, MD, Principal Investigator, UC Irvine, Department of Urology


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