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FloSeal Tubeless Exit Versus Cope Loop Nephrostomy Versus Fascial Stitch Following Percutaneous Nephrolithotripsy
This study is ongoing, but not recruiting participants.
Study NCT00360477   Information provided by University of California, Irvine
First Received: August 3, 2006   Last Updated: June 3, 2009   History of Changes

August 3, 2006
June 3, 2009
June 2004
July 2009   (final data collection date for primary outcome measure)
To determine which method of treatment causes the least pain to the patient. [ Time Frame: one month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00360477 on ClinicalTrials.gov Archive Site
 
 
 
FloSeal Tubeless Exit Versus Cope Loop Nephrostomy Versus Fascial Stitch Following Percutaneous Nephrolithotripsy
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.

 
 
Interventional
Treatment, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment, Bio-equivalence Study
Kidney Calculi
  • Procedure: Floseal
  • Procedure: Cope Loop
  • Procedure: Fascial Stitch
  • No Intervention: Floseal
  • No Intervention: Cope-Loop/Nephrostomy Tube
  • No Intervention: Fascial Stitch
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
30
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00360477
Ralph Clayman, MD, University of California, Irvine
2004-3515
University of California, Irvine
 
Principal Investigator: Ralph V. Clayman, MD UCIMC Department of Urology
University of California, Irvine
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP