Percutaneous Nephrolithotomy: A Registry and Database

NCT00159393 | Completed

• 1 other identifier: 03-096
• Study Type: observational
• Target: 1,697
• Locations: 1 country
• Sites: 2

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.

Conditions

Nephrolithiasis

Keywords

Kidney stones; nephrolithotripsy percutaneous

Interventions

registry and database OTHER

data collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

urology clinic patients already scheduled for percutaneous removal of kidney stones

You may qualify if:

• 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

You may not qualify if:

• Patients unable to give informed consent
• Patients with active bleeding diatheses
• Women who are pregnant or in whom pregnancy status cannot be confirmed

Sponsors & Collaborators

• Indiana Kidney Stone Institute: lead

Study Sites (2)

Indiana University Health

Carmel, Indiana, 46032, United States

Location

IU Health North Hospital

Carmel, Indiana, 46032, United States

Location

Related Publications (1)

• 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.

  PMID: 12692448 BACKGROUND

MeSH Terms

Conditions

Nephrolithiasis; Kidney Calculi

Interventions

Registries

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• James E Lingeman, MD

  IU Health Physicians Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: October 1, 2003
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

US (2)