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

NCT00360477 | Completed

• 1 other identifier: 2004-3515
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Calculi

Keywords

Kidney stone removal surgery

Outcome Measures

Primary Outcomes (1)

• To determine which method of treatment causes the least pain to the patient.

  one month

Study Arms (3)

1

ACTIVE COMPARATOR

Floseal

Procedure: Floseal

2

ACTIVE COMPARATOR

Cope-Loop/Nephrostomy Tube

Procedure: Cope Loop

3

ACTIVE COMPARATOR

Fascial Stitch

Procedure: Fascial Stitch

Interventions

Floseal PROCEDURE

Bioglue that seals the kidney

1

Cope Loop PROCEDURE

Nephrostomy tube for fluid drainage from the kidney

2

Fascial Stitch PROCEDURE

Stitch that closes the kidney

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has kidney stones that require treatment (tx) with percutaneous stone removal
• years of age or over

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Medical Center-Department of Urology

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Kidney Calculi

Interventions

FloSeal Matrix

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael K Louie, MD

  UC Irvine, Department of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman

Study Record Dates

• First Submitted: August 3, 2006
• First Posted: August 4, 2006
• Study Start: June 1, 2004
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2015
• Last Updated: December 13, 2016

Record last verified: 2016-12

Locations

US (1)