Percutaneous Nephrolithotomy: A Registry and Database

NCT ID: NCT00159393

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1697 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2018-12-31

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.

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.

Conditions

Nephrolithiasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

registry and database

data collection

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana Kidney Stone Institute

OTHER

Sponsor Role: lead

Responsible Party

James Lingeman

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James E Lingeman, MD

Role: PRINCIPAL_INVESTIGATOR

IU Health Physicians Urology

Locations

Indiana University Health

Carmel, Indiana, United States

IU Health North Hospital

Carmel, Indiana, United States

Countries

United States

References

Kim SC, Kuo RL, Lingeman JE. Percutaneous nephrolithotomy: an update. Curr Opin Urol. 2003 May;13(3):235-41. doi: 10.1097/00042307-200305000-00012.

Reference Type: BACKGROUND

PMID: 12692448 (View on PubMed)

Other Identifiers

03-096

Identifier Type: -

Identifier Source: org_study_id