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

Primary Purpose

Kidney Calculi

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Floseal
Cope Loop
Fascial Stitch
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Calculi focused on measuring Kidney stone removal surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Irvine Medical Center-Department of Urology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Floseal

Cope-Loop/Nephrostomy Tube

Fascial Stitch

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 3, 2006
Last Updated
December 12, 2016
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT00360477
Brief Title
FloSeal Tubeless Exit Versus Cope Loop Nephrostomy Versus Fascial Stitch Following Percutaneous Nephrolithotripsy
Official Title
Prospective Randomized Trial of Floseal Tubeless Exit vs. Cope Loop Nephrostomy vs. Fascial Stitch Following Percutaneous Nephrolithotripsy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Calculi
Keywords
Kidney stone removal surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Floseal
Arm Title
2
Arm Type
Active Comparator
Arm Description
Cope-Loop/Nephrostomy Tube
Arm Title
3
Arm Type
Active Comparator
Arm Description
Fascial Stitch
Intervention Type
Procedure
Intervention Name(s)
Floseal
Intervention Description
Bioglue that seals the kidney
Intervention Type
Procedure
Intervention Name(s)
Cope Loop
Intervention Description
Nephrostomy tube for fluid drainage from the kidney
Intervention Type
Procedure
Intervention Name(s)
Fascial Stitch
Intervention Description
Stitch that closes the kidney
Primary Outcome Measure Information:
Title
To determine which method of treatment causes the least pain to the patient.
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael K Louie, MD
Organizational Affiliation
UC Irvine, Department of Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine Medical Center-Department of Urology
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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