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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
Sponsor:
Information provided by (Responsible Party):
Carlos Villanueva, MD, University of Nebraska

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 31 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Intervention Details:
  • Procedure: Extravesical ureteral reimplantation
    Extravesical ureteral reimplantation with or without tapering


Primary Outcome Measures :
  1. Reoperation [ Time Frame: 1 year ]
    Need for reoperation either for persistent documented obstruction or reflux with recurrent febrile UTI's


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants (under 6 months of age) undergoing an extravesical ureteral reimplant for primary obstructed megaureter or ectopic ureter.
Criteria

Inclusion criteria:

  • Children younger 6 months of age who have been recommended by their urologist to have a unilateral ureteral reimplant.
  • Unilateral obstructive disease (as defined by the BAPU)
  • Ipsilateral Single system
  • Ipsilateral VUR is ok
  • Contralateral reflux grades 1-3 ok as long as the reflux will be observed

Exclusion criteria

  • Duplicated systems
  • First Febrile UTI's and megaureter or ectopic ureter but no evidence of obstruction or loss of function
  • Neurogenic bladder, valves
  • Contralateral reflux grade 4-5

Information from the National Library of Medicine

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


Contacts
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Contact: Carlos A Villanueva, MD 4029903634 cvillanueva.uro@gmail.com

Locations
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United States, Nebraska
Children's Hospital and Medical Center Recruiting
Omaha, Nebraska, United States, 68114
Contact: Carlos A Villanueva, M.D.    402-990-3634    cvillanueva.uro@gmail.com   
Sponsors and Collaborators
University of Nebraska

Publications:

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Responsible Party: Carlos Villanueva, MD, Clinical Service Chief of Pediatric Urology Assistant Professor of Surgery, Urology, University of Nebraska
ClinicalTrials.gov Identifier: NCT02419339     History of Changes
Other Study ID Numbers: 368-15-EP
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Ureteral Obstruction
Ureteral Diseases
Urologic Diseases