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

Not Applicable

Completed

• Conditions: Kidney Calculi
• Interventions: Procedure: Cope Loop; Procedure: Floseal; Procedure: Fascial Stitch

• Registration Number: NCT00360477
• Lead Sponsor: University of California, Irvine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2006-08-03
• Study First Submitted QC: 2006-08-03
• Study First Posted: 2006-08-04
• Primary Completion: 2014-10
• Study Completion: 2015-01
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-12
• Last Update Posted: 2016-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Cope Loop	Cope-Loop/Nephrostomy Tube
1	Floseal	Floseal
3	Fascial Stitch	Fascial Stitch

Primary Outcome Measures

Name	Time	Method
To determine which method of treatment causes the least pain to the patient.	one month

Trial Locations

Locations (1)

University of California, Irvine Medical Center-Department of Urology; 🇺🇸 Orange, California, United States