Prospective Pediatric Vesicoureteral Reflux Surgery Database

Vesicoureteral Reflux Clinical Trial

Official title:

Prospective Pediatric Vesicoureteral Reflux Surgery Database

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373385
• Other study ID #: 10-049
• Status: Completed
• Phase: N/A
• First received: July 14, 2010
• Last updated: January 3, 2017
• Start date: July 2010
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: Connecticut Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Vesico-Ureteral Reflux
• Vesicoureteral Reflux

Locations

Country	Name	City	State
United States	Connecticut Children's Medical Center	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Connecticut Children's Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of vesicoureteral reflux	Resolution of vesicoureteral reflux	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.	No