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Prospective Pediatric Pyeloplasty Robotic Surgical Database

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00882544
First Posted: April 16, 2009
Last Update Posted: March 20, 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):
Connecticut Children's Medical Center
  Purpose

Performance and outcomes measure are, at this time, relatively unknown for robotic pyeloplasty procedures. The purpose of this study is to provide a clearer understanding of the urology department's robotic pyeloplasty quality and outcomes measures. This will be accomplished by prospectively collecting data for these procedures would ensure that measures are consistently collected in accordance with a defined protocol, allowing for more valuable quality and clinical research analysis.

Hypothesis will be defined before data analysis is performed. Amendments specifying future hypothesis will be submitted the IRB at the appropriate time.


Condition
Hydronephrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Pediatric Pyeloplasty Robotic Surgical Database

Further study details as provided by Connecticut Children's Medical Center:

Primary Outcome Measures:
  • Resolution of Hydronephrosis [ Time Frame: 3 to 6 months after surgical intervention ]

Secondary Outcome Measures:
  • Symptom Resolution at follow-up [ Time Frame: 3 to 6 months after surgical intervention ]
  • Drainage at Follow-up by MAG3 [ Time Frame: 3 to 6 months after surgical intervention ]

Enrollment: 78
Study Start Date: March 2009
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diagnosed Pediatric Hydronephrosis
Children diagnosed with hydronephrosis who are to receive robotic pyeloplasty surgery

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children 0-18 years of age who receive a robotic pyeloplasty procedure at Connecticut Children's Medical Center
Criteria

Inclusion Criteria:

  • Subject received a robotic pyeloplasty procedure at Connecticut Children's Medical Center
  • Subject signs informed consent and HIPAA Authorization

Exclusion Criteria:

  • Subject did not receive a robotic pyeloplasty procedure at Connecticut Children's Medical Center
  • Subject does not sign informed consent and/or HIPAA Authorization
  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): NCT00882544


Locations
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Connecticut Children's Medical Center
Investigators
Study Director: Katherine W Herbst, M.Sc Connecticut Children's Medical Center
  More Information

Publications:
Responsible Party: Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT00882544     History of Changes
Other Study ID Numbers: 08-112
First Submitted: April 15, 2009
First Posted: April 16, 2009
Last Update Posted: March 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Connecticut Children's Medical Center:
hydronephrosis
robotic pyeloplasty
pediatric pyeloplasty

Additional relevant MeSH terms:
Hydronephrosis
Kidney Diseases
Urologic Diseases