Laparoscopic Pyeloplasty Registry and Database
This study is currently recruiting participants.
(see Contacts and Locations)
Verified December 2014 by Indiana Kidney Stone Institute
Sponsor:
Indiana Kidney Stone Institute
Information provided by (Responsible Party):
Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier:
NCT00169650
First received: September 9, 2005
Last updated: December 31, 2014
Last verified: December 2014
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Purpose
The gold standard for the treatment of ureteropelvic junction obstruction (UPJO) is the open pyeloplasty. As a minimally invasive alternative, many centers are currently offering laparoscopic pyeloplasty (LP) as primary therapy for UPJOs. Recent data has shown that laparoscopic pyeloplasty has comparable success rates to open pyeloplasties and produces durable results. The researchers are compiling a registry and database to review outcomes of laparoscopic pyeloplasty patients.
| Condition | Intervention |
|---|---|
|
Ureteral Obstruction |
Other: Registry and database |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Laparoscopic Pyeloplasty: A Registry and Database |
Further study details as provided by Indiana Kidney Stone Institute:
Primary Outcome Measures:
- To record and review the surgical outcomes of our population of UPJO patients who have been treated with LP. Once all retrospective data has been reviewed, we will continue to collect outcome data on a prospective basis [ Time Frame: One year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2003 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Registry and database of subjects undergoing laparoscopic pyeloplasty for ureteropelvic junction obstruction
|
Other: Registry and database
Subjects undergoing laparoscopic pyeloplasty for ureteropelvic junction obstruction at Methodist Urology in Indiana will be asked to participate in a registry and database to review outcomes of the surgery.
|
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
Subjects undergoing laparoscopic pyeloplasty for ureteropelvic junction obstruction
Criteria
Inclusion Criteria:
- Male or female patients of Methodist Urology in Indianapolis, IN over the age of 18 with ureteropelvic junction obstruction
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
- Patients with medical conditions precluding laparoscopy
- Patients with active urinary tract infection
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: NCT00169650
Please refer to this study by its ClinicalTrials.gov identifier: NCT00169650
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 Lingeman, MD | |
Sponsors and Collaborators
Indiana Kidney Stone Institute
Investigators
| Principal Investigator: | James E Lingeman, MD | IU Health Physicians Urology |
More Information
Additional Information:
No publications provided
| Responsible Party: | Indiana Kidney Stone Institute |
| ClinicalTrials.gov Identifier: | NCT00169650 History of Changes |
| Other Study ID Numbers: | 03-048 |
| Study First Received: | September 9, 2005 |
| Last Updated: | December 31, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Indiana Kidney Stone Institute:
|
UPJ Obstruction Renal Obstruction Delayed Renal Flow |
Additional relevant MeSH terms:
|
Ureteral Obstruction Ureteral Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on February 27, 2015