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

NCT00360477 — Not applicable, Completed, 59 participants, University of California, Irvine

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Prospective Randomized Trial of Floseal Tubeless Exit vs. Cope Loop Nephrostomy vs. Fascial Stitch Following Percutaneous Nephrolithotripsy

Registry	NCT00360477
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	59 (Actual)
Sponsor	University of California, Irvine (Other)
Conditions	Kidney Calculi
Interventions	Floseal, Cope Loop, Fascial Stitch (Procedure)
Dates	start 2004-06-01, primary completion 2014-10-01, completion 2015-01-01, first posted 2006-08-04, last updated 2016-12-13
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
1	Active comparator	Procedure: Floseal	Floseal
2	Active comparator	Procedure: Cope Loop	Cope-Loop/Nephrostomy Tube
3	Active comparator	Procedure: Fascial Stitch	Fascial Stitch

Floseal (Procedure): Bioglue that seals the kidney
Cope Loop (Procedure): Nephrostomy tube for fluid drainage from the kidney
Fascial Stitch (Procedure): Stitch that closes the kidney

+Outcome measures

Primary outcomes

To determine which method of treatment causes the least pain to the patient. [one month]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
University of California, Irvine Medical Center-Department of Urology	Orange, California	United States

+Investigators

Michael K Louie, MD, Principal investigator, UC Irvine, Department of Urology