Percutaneous Nephrolithotomy: A Registry and Database

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Indiana Kidney Stone Institute
Sponsor:
Information provided by (Responsible Party):
Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier:
NCT00159393
First received: September 8, 2005
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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 Intervention
Nephrolithiasis
Other: registry and database

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Percutaneous Nephrolithotomy: A Registry and Database

Resource links provided by NLM:


Further study details as provided by Indiana Kidney Stone Institute:

Estimated Enrollment: 2000
Study Start Date: October 2003
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: registry and database
    data collection
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

urology clinic patients already scheduled for percutaneous removal of kidney stones

Criteria

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
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: NCT00159393

Contacts
Contact: Lori Rawlings, RN 317-962-0870 lrawlings@iuhealth.org

Locations
United States, Indiana
IU Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lori Rawlings, RN    317-962-0870    lrawlings@iuhealth.org   
Principal Investigator: James E Lingeman, MD         
Sponsors and Collaborators
Indiana Kidney Stone Institute
Investigators
Principal Investigator: James E Lingeman, MD IU Health Physicians Urology
  More Information

Additional Information:
Publications:
Responsible Party: Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier: NCT00159393     History of Changes
Other Study ID Numbers: 03-096
Study First Received: September 8, 2005
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana Kidney Stone Institute:
Kidney stones
nephrolithotripsy percutaneous

Additional relevant MeSH terms:
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis

ClinicalTrials.gov processed this record on July 31, 2014