Prospective Pediatric Vesicoureteral Reflux Surgery Database
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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 |
- 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 |
All patients receiving a surgical procedure for viesicoureteral reflux at Connecticut Children's Medical Center.
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| Contact: Christina Kim Kim, MD | 860-545-9520 | ckim@ccmckids.org |
| Contact: Kathy Herbst, M.Sc. | 860-545-9520 | kherbst@ccmckids.org |
| 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 | |
| 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 May 19, 2013