Prospective Pediatric Vesicoureteral Reflux Surgery Database

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Connecticut Children's Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT01373385
First received: July 14, 2010
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

The purpose of this research is to provide a clearer understanding of quality and outcomes for three types of surgical procedures performed at Connecticut Children's for treatment of vesicoureteral reflux. In order to consistently gather data over time, the investigators propose to establish database for surgical intervention for vesicoureteral reflux.

Specific Aim 1: To consistently collect performance and outcomes data for the surgical treatment of vesicoureteral reflux in order to increase internal understanding of these procedures.

Specific Aim2: To consistently collect performance and outcomes data for the surgical treatment of vesicoureteral reflux in order to perform more valuable clinical analysis for publication.


Condition
Vesicoureteral Reflux

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Pediatric Vesicoureteral Reflux Surgery Database

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Resolution of vesicoureteral reflux [ Time Frame: Date of surgical intervention (day 1) to resolution of vesicoureteral reflux or additional surgical interventions for correction of vesicoureteral reflux, whichever comes first, or until enrollee's 18th birthday. ] [ Designated as safety issue: No ]
    Resolution of vesicoureteral reflux


Estimated Enrollment: 200
Study Start Date: July 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Surgical
Patients receiving a surgical procedure for vesicoureteral reflux at Connecticut Children's Medical Center.

  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

All patients receiving a surgical procedure for viesicoureteral reflux at Connecticut Children's Medical Center.

Criteria

Inclusion Criteria:

  • Subject scheduled to receive surgical intervention for the treatment of vesicoureteral reflux at Connecticut Children's.

Exclusion Criteria:

  • Subject not scheduled to receive surgical intervention for the treatment of vesicoureteral reflux at Connecticut Children's.
  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: NCT01373385

Contacts
Contact: Christina Kim Kim, MD 860-545-9520 ckim@ccmckids.org
Contact: Kathy 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: Christina Kim, MD    860-545-9520    ckim@ccmckids.org   
Contact: Kathy Herbst, M.Sc.    860-545-9520    kherbst@ccmckids.org   
Principal Investigator: Christina Kim, MD         
Sub-Investigator: Fernando Ferrer, MD         
Sub-Investigator: John Makari, MD         
Sponsors and Collaborators
Connecticut Children's Medical Center
Investigators
Principal Investigator: Christina Kim, MD Connecticut Children's Medical Center
  More Information

No publications provided

Responsible Party: Christina Kim, M.D. / Pediatric Urologist, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT01373385     History of Changes
Other Study ID Numbers: 10-049
Study First Received: July 14, 2010
Last Updated: July 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Connecticut Children's Medical Center:
pediatric urology
vesicoureteral reflux
ureteral reimplant
Deflux

Additional relevant MeSH terms:
Gastroesophageal Reflux
Vesico-Ureteral Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 27, 2014