Laparoscopic Pyeloplasty Registry and Database

Sponsor

Indiana Kidney Stone Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00169650

Collaborator

(none)

Enrollment

Location

161.1

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ureteral Obstruction	Other: Registry and database

Study Design

Study Type:

Observational

Actual Enrollment :

64 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Laparoscopic Pyeloplasty: A Registry and Database

Study Start Date :

Jul 1, 2003

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

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 [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Indiana Kidney Stone Institute

ClinicalTrials.gov Identifier:

NCT00169650

Other Study ID Numbers:

03-048

First Posted:

Sep 15, 2005

Last Update Posted:

Feb 16, 2017

Last Verified:

Feb 1, 2017

Keywords provided by Indiana Kidney Stone Institute

UPJ Obstruction

Renal Obstruction

Delayed Renal Flow

Additional relevant MeSH terms:

Ureteral Obstruction

Study Results

No Results Posted as of Feb 16, 2017