Percutaneous Nephrolithotomy: A Registry and Database
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| Estimated Enrollment: | 2000 |
| Study Start Date: | October 2003 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
-
Other: registry and database
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 |
urology clinic patients already scheduled for percutaneous removal of kidney stones
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| Contact: Lori Rawlings, RN | 317-962-0870 | lrawlings@iuhealth.org |
| 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 | |
| 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: | December 4, 2012 |
| 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 May 19, 2013