Prospective Pediatric Vesicoureteral Reflux Surgery Database

NCT01373385 | Completed

• 1 other identifier: 10-049
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Vesicoureteral Reflux

Keywords

pediatric urology; vesicoureteral reflux; ureteral reimplant; Deflux

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Surgical

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

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Vesico-Ureteral Reflux

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Christina Kim, MD

  Connecticut Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: June 15, 2011
• Study Start: July 1, 2010
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 5, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)