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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Victor Huynh, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00360477
First received: August 3, 2006
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Kidney Calculi
Procedure: Floseal
Procedure: Cope Loop
Procedure: Fascial Stitch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Floseal Tubeless Exit vs. Cope Loop Nephrostomy vs. Fascial Stitch Following Percutaneous Nephrolithotripsy

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • To determine which method of treatment causes the least pain to the patient. [ Time Frame: one month ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2004
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Floseal
Procedure: Floseal
Bioglue that seals the kidney
Active Comparator: 2
Cope-Loop/Nephrostomy Tube
Procedure: Cope Loop
Nephrostomy tube for fluid drainage from the kidney
Active Comparator: 3
Fascial Stitch
Procedure: Fascial Stitch
Stitch that closes the kidney

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360477

Locations
United States, California
University of California, Irvine Medical Center-Department of Urology
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Michael K Louie, MD UC Irvine, Department of Urology
  More Information

No publications provided

Responsible Party: Victor Huynh, Urology Contact, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00360477     History of Changes
Other Study ID Numbers: 2004-3515
Study First Received: August 3, 2006
Last Updated: August 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Kidney stone removal surgery

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 30, 2014