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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00360477
Recruitment Status : Completed
First Posted : August 4, 2006
Last Update Posted : December 13, 2016
Information provided by (Responsible Party):
Jaime Landman, University of California, Irvine

Brief Summary:
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 or disease Intervention/treatment Phase
Kidney Calculi Procedure: Floseal Procedure: Cope Loop Procedure: Fascial Stitch Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Floseal Tubeless Exit vs. Cope Loop Nephrostomy vs. Fascial Stitch Following Percutaneous Nephrolithotripsy
Study Start Date : June 2004
Actual Primary Completion Date : October 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Procedure: Floseal
Bioglue that seals the kidney
Active Comparator: 2
Cope-Loop/Nephrostomy Tube
Procedure: Cope Loop
Nephrostomy tube for fluid drainage from the kidney
Active Comparator: 3
Fascial Stitch
Procedure: Fascial Stitch
Stitch that closes the kidney

Primary Outcome Measures :
  1. To determine which method of treatment causes the least pain to the patient. [ Time Frame: one month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00360477

United States, California
University of California, Irvine Medical Center-Department of Urology
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Principal Investigator: Michael K Louie, MD UC Irvine, Department of Urology

Responsible Party: Jaime Landman, Professor and Chairman, University of California, Irvine Identifier: NCT00360477     History of Changes
Other Study ID Numbers: 2004-3515
First Posted: August 4, 2006    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016

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

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