Laparoscopic Pyeloplasty Registry and Database

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Indiana Kidney Stone Institute

ClinicalTrials.gov Identifier:

NCT00169650

First received: September 9, 2005

Last updated: February 22, 2016

Last verified: February 2016

History of Changes

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 ]


Enrollment:	64
Study Start Date:	July 2003
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2016 (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 (Adult, Senior)
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

Locations


United States, Indiana
IU Health Methodist Hospital
Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Indiana Kidney Stone Institute

Investigators


Principal Investigator:	James E Lingeman, MD	IU Health Physicians Urology

More Information


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:	February 22, 2016
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 September 29, 2016

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