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

NCT ID: NCT00360477

Last Updated: 2016-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2015-01-31

Brief Summary

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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

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Conditions

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Kidney Calculi

Keywords

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Kidney stone removal surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Floseal

Group Type ACTIVE_COMPARATOR

Floseal

Intervention Type PROCEDURE

Bioglue that seals the kidney

2

Cope-Loop/Nephrostomy Tube

Group Type ACTIVE_COMPARATOR

Cope Loop

Intervention Type PROCEDURE

Nephrostomy tube for fluid drainage from the kidney

3

Fascial Stitch

Group Type ACTIVE_COMPARATOR

Fascial Stitch

Intervention Type PROCEDURE

Stitch that closes the kidney

Interventions

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Floseal

Bioglue that seals the kidney

Intervention Type PROCEDURE

Cope Loop

Nephrostomy tube for fluid drainage from the kidney

Intervention Type PROCEDURE

Fascial Stitch

Stitch that closes the kidney

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Jaime Landman

Professor and Chairman

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael K Louie, MD

Role: PRINCIPAL_INVESTIGATOR

UC Irvine, Department of Urology

Locations

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University of California, Irvine Medical Center-Department of Urology

Orange, California, United States

Site Status

Countries

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United States

Other Identifiers

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2004-3515

Identifier Type: -

Identifier Source: org_study_id