Prospective Pediatric Vesicoureteral Reflux Surgery Database
This study is currently recruiting participants.
Verified July 2012 by Connecticut Children's Medical Center
Sponsor:
Connecticut Children's Medical Center
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 14, 2010 | ||||||||
| Last Updated Date | July 3, 2012 | ||||||||
| Start Date ICMJE | July 2010 | ||||||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01373385 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Prospective Pediatric Vesicoureteral Reflux Surgery Database | ||||||||
| Official Title ICMJE | Prospective Pediatric Vesicoureteral Reflux Surgery Database | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | All patients receiving a surgical procedure for viesicoureteral reflux at Connecticut Children's Medical Center. |
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| Condition ICMJE | Vesicoureteral Reflux | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Surgical
Patients receiving a surgical procedure for vesicoureteral reflux at Connecticut Children's Medical Center. |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 18 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01373385 | ||||||||
| Other Study ID Numbers ICMJE | 10-049 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Christina Kim, M.D. / Pediatric Urologist, Connecticut Children's Medical Center | ||||||||
| Study Sponsor ICMJE | Connecticut Children's Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Connecticut Children's Medical Center | ||||||||
| Verification Date | July 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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