Laparoscopic Pyeloplasty Registry and Database - Full Text View

Sponsored by:	Indiana Kidney Stone Institute
Information provided by:	Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier:	NCT00169650

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	July 2003
Estimated Study Completion Date:	April 2009

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169650

Contacts

Contact: Shelly Handa, RN

317-962-0870

shanda@clarian.org

Locations

United States, Indiana
Methodist Hospital	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Shelly Handa, RN 317-962-0870 shanda@clarian.org
Sub-Investigator: Larry Munch, MD

Sponsors and Collaborators

Indiana Kidney Stone Institute

Investigators

Principal Investigator:

James E Lingeman, MD

Methodist Urology, LLC

More Information

click here to view other studies being done by Methodist Urology This link exits the ClinicalTrials.gov site

Responsible Party:	Methodist Urology ( James Lingeman )
Study ID Numbers:	03-048
Study First Received:	September 9, 2005
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00169650
Health Authority:	United States: Institutional Review Board

Keywords provided by Indiana Kidney Stone Institute:

UPJ Obstruction
Renal Obstruction
Delayed Renal Flow

Study placed in the following topic categories:

Urologic Diseases
Ureteral Obstruction
Ureteral Diseases

ClinicalTrials.gov processed this record on January 13, 2009