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Laparoscopic Pyeloplasty Registry and Database

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00169650
First Posted: September 15, 2005
Last Update Posted: February 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Indiana Kidney Stone Institute
  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 ]

Enrollment: 64
Study Start Date: July 2003
Study Completion Date: December 2016
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

Information from the National Library of Medicine

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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
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

Additional Information:
Responsible Party: Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier: NCT00169650     History of Changes
Other Study ID Numbers: 03-048
First Submitted: September 9, 2005
First Posted: September 15, 2005
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