NCT00360477

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Calculi

Interventions

Type	Name	Description
PROCEDURE	Floseal	Bioglue that seals the kidney
PROCEDURE	Cope Loop	Nephrostomy tube for fluid drainage from the kidney
PROCEDURE	Fascial Stitch	Stitch that closes the kidney

Timeline

• Start date: 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 across 1 country: United States