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Laparoscopic Pyeloplasty Registry and Database

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ClinicalTrials.gov Identifier: NCT00169650
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Indiana Kidney Stone Institute

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Ureteral Obstruction Other: Registry and database

Study Design
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Study Type : Observational
Actual Enrollment : 64 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Laparoscopic Pyeloplasty: A Registry and Database
Study Start Date : July 2003
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016
Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Responsible Party: Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier: NCT00169650     History of Changes
Other Study ID Numbers: 03-048
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017

Keywords provided by Indiana Kidney Stone Institute:
UPJ Obstruction
Renal Obstruction
Delayed Renal Flow

Additional relevant MeSH terms:
Ureteral Obstruction
Ureteral Diseases
Urologic Diseases