Percutaneous Nephrolithotomy: A Registry and Database

Sponsor
Indiana Kidney Stone Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00159393
Collaborator
(none)
1,697
2
182
848.5
4.7

Study Details

Study Description

Brief Summary

Kidney stones vary in size from a tiny grain of sand to as large as filling the inside of the kidney. Treatment decisions depend on the size, location, and composition of the stone. Some kidney stones can be treated with lithotripsy (breaking up stones inside the body with shock waves created outside the body) or ureteroscopy (placing a small telescope up the urine channel to remove the stone). When stones are large in size or in the lower part of the kidney, a percutaneous (making a passage from the back into the kidney) procedure has been found to be the best method to remove the stones safely and efficiently. A passage is made into the back to allow a small telescope to see the stone and break it into fragments for removal. A small catheter is placed at the end of the procedure to allow the kidney to drain.

The purpose of this study is to record information about your surgery into a database so we can look at how patients who have had this procedure have done over time. We hope that reporting the outcomes of this surgery will be helpful to urologists and patients in the future. There may be certain factors that can be identified through this study as having better outcomes that may help make future surgeries safer.

Condition or Disease Intervention/Treatment Phase
  • Other: registry and database

Detailed Description

Patients of IU Health Physicians Urology who have been scheduled to undergo percutaneous removal of one or more kidney stones will be asked to consent to be part of our registry and database for percutaneous procedures. The database contains information about the subjects surgery, such as stone size and location, number of access sites to remove the stone, length of stay in the hospital, secondary procedures, etc. This information is reviewed periodically to look for trends so that physicians may find ways to improve the percutaneous procedure. All information in the database is kept confidential. Data is collected at follow-up appointments at one month and one year to see if the subject is still stone free.

Study Design

Study Type:
Observational
Actual Enrollment :
1697 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Percutaneous Nephrolithotomy: A Registry and Database
Study Start Date :
Oct 1, 2003
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    INCLUSION CRITERIA:
    • Patients of Methodist Urology in Indianapolis, IN

    • Male or female patients with upper urinary tract stone disease appropriate for percutaneous removal as determined by a Methodist Urology physician

    EXCLUSION CRITERIA:
    • Patients unable to give informed consent

    • Patients with active bleeding diatheses

    • Women who are pregnant or in whom pregnancy status cannot be confirmed

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Indiana University Health Carmel Indiana United States 46032
    2 IU Health North Hospital Carmel Indiana United States 46032

    Sponsors and Collaborators

    • Indiana Kidney Stone Institute

    Investigators

    • Principal Investigator: James E Lingeman, MD, IU Health Physicians Urology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    James Lingeman, Director, Indiana Kidney Stone Institute
    ClinicalTrials.gov Identifier:
    NCT00159393
    Other Study ID Numbers:
    • 03-096
    First Posted:
    Sep 12, 2005
    Last Update Posted:
    Feb 11, 2021
    Last Verified:
    Feb 1, 2021
    Keywords provided by James Lingeman, Director, Indiana Kidney Stone Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 11, 2021