FloSeal Tubeless Exit Versus Cope Loop Nephrostomy Versus Fascial Stitch Following Percutaneous Nephrolithotripsy
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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: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Prospective Randomized Trial of Floseal Tubeless Exit vs. Cope Loop Nephrostomy vs. Fascial Stitch Following Percutaneous Nephrolithotripsy |
- 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: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
Floseal
|
Procedure: Floseal
Bioglue that seals the kidney
|
|
No Intervention: 2
Cope-Loop/Nephrostomy Tube
|
Procedure: Cope Loop
Nephrostomy tube for fluid drainage from the kidney
|
|
No Intervention: 3
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 |
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| United States, California | |
| University of California, Irvine Medical Center-Department of Urology | |
| Orange, California, United States, 92868 | |
| Principal Investigator: | Michael K Louie, MD | UC Irvine, Department of Urology |
More Information
No publications provided
| Responsible Party: | Michael Louie, MD, University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00360477 History of Changes |
| Other Study ID Numbers: | 2004-3515 |
| Study First Received: | August 3, 2006 |
| Last Updated: | August 15, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Irvine:
|
Kidney stone removal surgery |
Additional relevant MeSH terms:
|
Calculi Kidney Calculi Pathological Conditions, Anatomical Nephrolithiasis |
Kidney Diseases Urologic Diseases Urolithiasis Urinary Calculi |
ClinicalTrials.gov processed this record on May 19, 2013