Prospective Pediatric Pyeloplasty Robotic Surgical Database

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Connecticut Children's Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT00882544
First received: April 15, 2009
Last updated: February 9, 2012
Last verified: February 2012
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptom Resolution at follow-up [ Time Frame: 3 to 6 months after surgical intervention ] [ Designated as safety issue: No ]
  • Drainage at Follow-up by MAG3 [ Time Frame: 3 to 6 months after surgical intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (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

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
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: NCT00882544

Contacts
Contact: Christina Kim, M.D. 860-545-9520 ckim@ccmckids.org
Contact: Katherine W. Herbst, M.Sc. 860-545-9520 kherbst@ccmckids.org

Locations
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Katherine W Herbst, M.Sc.    860-545-9520    kherbst@ccmckids.org   
Contact: Barbara Mulholland, R.N.    860-545-9520    bmulholland@ccmckids.org   
Principal Investigator: Christina Kim, M.D.         
Sub-Investigator: Katherine W Herbst, M.Sc.         
Sub-Investigator: Barbara Mulholland, R.N.         
Sponsors and Collaborators
Connecticut Children's Medical Center
Investigators
Principal Investigator: Christina Kim, M.D. Connecticut Children's Medical Center
  More Information

Publications:
Responsible Party: Christina Kim, M.D., Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT00882544     History of Changes
Other Study ID Numbers: 08-112
Study First Received: April 15, 2009
Last Updated: February 9, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hydronephrosis
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014