Early Infancy Ureteral Reimplantation for Distal Ureteral Obstruction
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|ClinicalTrials.gov Identifier: NCT02419339|
Recruitment Status : Recruiting
First Posted : April 17, 2015
Last Update Posted : October 17, 2018
Prospective multicenter observational study of early infancy ureteral reimplantation for distal ureteral obstruction.
The study is an observation study since the investigators will not assign specific interventions to the subjects of the study.
The purpose of the study is to describe the surgical outcomes of early infancy ureteral reimplantation. Infants under 6 months of age with unilateral obstructed distal ureter, no other urologic pathologic and a normal contralateral kidney who have been recommended a ureteral reimplant by their pediatric urologist are eligible for the study. Patients that consent for the study will be prospectively followed for 1 year to record the outcomes of the surgery.
|Condition or disease||Intervention/treatment|
|Ureteral Obstruction Urinary Diversion||Procedure: Extravesical ureteral reimplantation|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||31 participants|
|Official Title:||Prospective Multicenter Observational Study of Early Infancy Ureteral Reimplantation for Distal Ureteral Obstruction|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
- Procedure: Extravesical ureteral reimplantation
Extravesical ureteral reimplantation with or without tapering
- Reoperation [ Time Frame: 1 year ]Need for reoperation either for persistent documented obstruction or reflux with recurrent febrile UTI's
- Recurrent Febrile UTI's [ Time Frame: 1 year ]Recurrent febrile urinary tract infections defined as fever more than 38.5, positive urine culture with more than 100,000 organism from a cath specimen and urine analysis with more than 10 leukocytes per high power field.
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): NCT02419339
|Contact: Carlos A Villanueva, MDemail@example.com|
|United States, Nebraska|
|Children's Hospital and Medical Center||Recruiting|
|Omaha, Nebraska, United States, 68114|
|Contact: Carlos A Villanueva, M.D. 402-990-3634 firstname.lastname@example.org|