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NCT00169650 Clinical Trial

Laparoscopic Pyeloplasty Registry and Database

Ureteral Obstruction Clinical Trial

Official title:
Laparoscopic Pyeloplasty: A Registry and Database

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00169650
Other study ID # 03-048
Secondary ID
Status Completed
Phase N/A
First received September 9, 2005
Last updated February 14, 2017
Start date July 2003
Est. completion date December 2016

Study information
Verified date February 2017
Source Indiana Kidney Stone Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States IU Health Methodist Hospital Indianapolis Indiana

Sponsors (1)
Lead Sponsor Collaborator
Indiana Kidney Stone Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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