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OpenTrials
Completed

NCT Number: NCT00360477

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Irvine Medical Center-Department of Urology

Orange, California, 92868, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Floseal

Procedure

Bioglue that seals the kidney

Cope Loop

Procedure

Nephrostomy tube for fluid drainage from the kidney

Fascial Stitch

Procedure

Stitch that closes the kidney

Primary outcomes

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

    Time frame: one month

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

Prospective Randomized Trial of Floseal Tubeless Exit vs. Cope Loop Nephrostomy vs. Fascial Stitch Following Percutaneous Nephrolithotripsy

Important dates

Study start
2004
Primary completion
2014
Study completion
2015
First posted
Aug 4, 2006
Registry last updated
Dec 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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