Laparoscopic Pyeloplasty Registry and Database - Tabular View

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

August 3, 2009

Start Date ^ICMJE

July 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00169650 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Laparoscopic Pyeloplasty Registry and Database

Official Title ^ICMJE

Laparoscopic Pyeloplasty: A Registry and Database

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Retrospective

Condition ^ICMJE

Ureteral Obstruction

Intervention ^ICMJE

Other: Registry and database

Study Arms / Comparison Groups

Registry and database of subjects undergoing laparoscopic pyeloplasty for ureteropelvic junction obstruction

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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2011

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Shelly Handa, RN

317-962-0870

shanda@clarian.org

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00169650

Responsible Party

James Lingeman, Methodist Urology

Study ID Numbers ^ICMJE

03-048

Study Sponsor ^ICMJE

Indiana Kidney Stone Institute

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

James E Lingeman, MD

Methodist Urology, LLC

Information Provided By

Indiana Kidney Stone Institute

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP