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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.
First Received: August 3, 2006   Last Updated: June 3, 2009   History of Changes
Sponsor: University of California, Irvine
Information provided by: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00360477
  Purpose

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.


Condition Intervention
Kidney Calculi
Procedure: Floseal
Procedure: Cope Loop
Procedure: Fascial Stitch

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment, Bio-equivalence Study
Official Title: Prospective Randomized Trial of Floseal Tubeless Exit vs. Cope Loop Nephrostomy vs. Fascial Stitch Following Percutaneous Nephrolithotripsy

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • To determine which method of treatment causes the least pain to the patient. [ Time Frame: one month ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2004
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: No Intervention
Floseal
Procedure: Floseal
Bioglue that seals the kidney
2: No Intervention
Cope-Loop/Nephrostomy Tube
Procedure: Cope Loop
Nephrostomy tube for fluid drainage from the kidney
3: No Intervention
Fascial Stitch
Procedure: Fascial Stitch
Stitch that closes the kidney

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00360477

Locations
United States, California
University of California, Irvine Medical Center-Department of Urology
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Ralph V. Clayman, MD UCIMC Department of Urology
  More Information

No publications provided

Responsible Party: University of California, Irvine ( Ralph Clayman, MD )
Study ID Numbers: 2004-3515
Study First Received: August 3, 2006
Last Updated: June 3, 2009
ClinicalTrials.gov Identifier: NCT00360477     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Kidney stone removal surgery

Additional relevant MeSH terms:
Pathological Conditions, Anatomical
Urinary Calculi
Urologic Diseases
Urolithiasis
Kidney Diseases
Calculi
Nephrolithiasis
Kidney Calculi

ClinicalTrials.gov processed this record on November 27, 2009