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Sponsored by: |
University of California, Irvine |
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Information provided by: | University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT00360477 |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 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
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Procedure: Fascial Stitch
Stitch that closes the kidney
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rosanne Santos | 714-456-8176 | rtsantos@uci.edu |
United States, California | |
University of California, Irvine Medical Center-Department of Urology | Recruiting |
Orange, California, United States, 92868 | |
Principal Investigator: Ralph V. Clayman, MD | |
Sub-Investigator: Elspeth McDougall, MD |
Principal Investigator: | Ralph V. Clayman, MD | UCIMC Department of Urology |
Responsible Party: | University of California, Irvine ( Ralph Clayman, MD ) |
Study ID Numbers: | 2004-3515 |
Study First Received: | August 3, 2006 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00360477 |
Health Authority: | United States: Institutional Review Board |
Kidney stone removal surgery |
Pathological Conditions, Anatomical Urinary Calculi Urologic Diseases Urolithiasis |
Kidney Diseases Calculi Nephrolithiasis Kidney Calculi |