|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 3, 2006 | ||||
| Last Updated Date | June 3, 2009 | ||||
| Start Date ICMJE | June 2004 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To determine which method of treatment causes the least pain to the patient. [ Time Frame: one month ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00360477 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | FloSeal Tubeless Exit Versus Cope Loop Nephrostomy Versus Fascial Stitch Following Percutaneous Nephrolithotripsy | ||||
| Official Title ICMJE | Prospective Randomized Trial of Floseal Tubeless Exit vs. Cope Loop Nephrostomy vs. Fascial Stitch Following Percutaneous Nephrolithotripsy | ||||
| Brief Summary | The patient will be asked to participate in a research project designed to determine the best way to prevent bleeding and promote patient comfort after having kidney stones removed. Two standard methods for ending the surgery are being compared to a newer method. In one standard method, the patient will have a tube draining urine from the kidney after the procedure. This tube may also prevent bleeding from the kidney. In another standard method the patient will have a tube left internally that drains urine from the kidney to the bladder and a stitch will be used to close the incision and deeper tissues in the back. In the third potential option, a tube would be left internally to drain urine from the kidney to the patient's bladder and the surgical site would be filled with a clot promoting agent (FloSeal) which is a FDA approved agent specifically formulated to stop bleeding during surgical procedures. |
||||
| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment, Bio-equivalence Study | ||||
| Condition ICMJE | Kidney Calculi | ||||
| Intervention ICMJE |
|
||||
| Study Arms / Comparison Groups |
|
||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | July 2009 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00360477 | ||||
| Responsible Party | Ralph Clayman, MD, University of California, Irvine | ||||
| Study ID Numbers ICMJE | 2004-3515 | ||||
| Study Sponsor ICMJE | University of California, Irvine | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of California, Irvine | ||||
| Verification Date | June 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||