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Ureteropelvic Junction Obstruction in Early Childhood: Comparison of Surgical Therapy and Surveillance. A Prospective, Randomized, Controlled Multi-Center Study (TOKU)

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ClinicalTrials.gov Identifier: NCT00444431
Recruitment Status : Unknown
Verified March 2007 by University Hospital, Essen.
Recruitment status was:  Not yet recruiting
First Posted : March 7, 2007
Last Update Posted : March 7, 2007
Sponsor:
Information provided by:
University Hospital, Essen

Study Description
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Brief Summary:
In this randomized trial surgical therapy and surveillance of ureteropelvic junction obstruction will be compared, regarding partial renal function.

Condition or disease Intervention/treatment Phase
Unilateral Ureteropelvic Junction Obstruction Procedure: Pyeloplasty Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ureteropelvic Junction Obstruction in Early Childhood: Comparison of Surgical Therapy and Surveillance in Children With Scintigraphically Prooved Obstruction. A Prospective, Randomized, Controlled Multi-Center Study
Study Start Date : March 2007
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. partial renal function

Eligibility Criteria
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Ages Eligible for Study:   4 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • unilateral ureteropelvic junction obstruction
  • diameter of renal pelvis greater 12 mm
  • partial renal function of 35%-55% proofed by scintigraphy
  • urodynamically relevant decrease in renal drainage proofed by diuresis scintigraphy at the age of 4 weeks up to 6 months
  • Abscence of clinical symptoms
  • Healthy contralateral kidney

Exclusion Criteria:

  • Global decrease in renal function
  • renal dystopia
  • megaureter
  • vesico-ureteral reflux
  • progressive hydronephrosis
  • oligohydrammnion
  • voiding dysfunction
  • bilateral hydronephrosis
  • severe chronical illness
  • decrease of partial renal function of more then 5% during allocation
Contacts and Locations
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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): NCT00444431


Contacts
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Contact: Achim Rose, Md 00492017233221 roseachim@web.de

Locations
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Germany
University Hospital of Essen, Department of Pediatric Nephrology
Essen, Nordrhein-Westfalen, Germany, 45122
Contact: Peter Hoyer, Prof.    00492017232810    peter.hoyer@uni-essen.de   
Principal Investigator: Peter Hoyer, Prof.         
University Hospital of Essen, Department of Urology
Essen, Nordrhein-Westfalen, Germany, 45122
Contact: Herbert Rübben, Prof.    00492017233211    herbert.ruebben@uni-essen.de   
Principal Investigator: Herbert Rübben, Prof.         
Sponsors and Collaborators
University Hospital, Essen
Investigators
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Principal Investigator: Herbert Rübben, Prof. University Hospital, Essen
Principal Investigator: Peter Hoyer, Prof. University Hospital, Essen
More Information
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ClinicalTrials.gov Identifier: NCT00444431    
Other Study ID Numbers: 2005-004090-13
First Posted: March 7, 2007    Key Record Dates
Last Update Posted: March 7, 2007
Last Verified: March 2007
Additional relevant MeSH terms:
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Hydronephrosis
Ureteral Obstruction
Multicystic Dysplastic Kidney
Kidney Diseases
Urologic Diseases
 Ureteral Diseases
Urogenital Abnormalities
Kidney Diseases, Cystic
Congenital Abnormalities