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

Kidney Calculi Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360477
• Other study ID #: 2004-3515
• Status: Completed
• Phase: N/A
• First received: August 3, 2006
• Last updated: December 12, 2016
• Start date: June 2004
• Est. completion date: January 2015

Study information

• Verified date: December 2016
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis

Intervention

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

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center-Department of Urology	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine which method of treatment causes the least pain to the patient.		one month	No