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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
  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

Additional 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 December 06, 2016