FloSeal Tubeless Exit Versus Cope Loop Nephrostomy Versus Fascial Stitch Following Percutaneous Nephrolithotripsy - Full Text View

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

U.S. FDA Resources

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

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:	December 2008
Estimated Primary Completion Date:	November 2008 (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

Contacts


Contact: Rosanne Santos	714-456-8176	rtsantos@uci.edu

Locations


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

Sponsors and Collaborators

University of California, Irvine

Investigators


Principal Investigator:	Ralph V. Clayman, MD	UCIMC Department of Urology

More Information

Responsible Party:	University of California, Irvine ( Ralph Clayman, MD )
Study ID Numbers:	2004-3515
First Received:	August 3, 2006
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00360477
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

Kidney stone removal surgery

Study placed in the following topic categories:

Pathological Conditions, Anatomical

Urinary Calculi

Urologic Diseases

Urolithiasis

Kidney Diseases

Calculi

Nephrolithiasis

Kidney Calculi

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	University of California, Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00360477