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Prospective Pediatric Vesicoureteral Reflux Surgery Database

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ClinicalTrials.gov Identifier: NCT01373385
Recruitment Status : Completed
First Posted : June 15, 2011
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
Vesicoureteral Reflux

Study Design

Study Type : Observational
Actual Enrollment : 134 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Pediatric Vesicoureteral Reflux Surgery Database
Study Start Date : July 2010
Primary Completion Date : November 2016
Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Surgical
Patients receiving a surgical procedure for vesicoureteral reflux at Connecticut Children's Medical Center.


Outcome Measures

Primary Outcome Measures :
  1. 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. ]
    Resolution of vesicoureteral reflux


Eligibility Criteria

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
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

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): NCT01373385


Locations
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Connecticut Children's Medical Center
Investigators
Principal Investigator: Christina Kim, MD Connecticut Children's Medical Center
More Information

Responsible Party: Christina Kim, MD, Attending physician, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT01373385     History of Changes
Other Study ID Numbers: 10-049
First Posted: June 15, 2011    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Christina Kim, MD, 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