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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by University Hospital, Essen.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00444431
First Posted: March 7, 2007
Last Update Posted: March 7, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Essen
  Purpose
In this randomized trial surgical therapy and surveillance of ureteropelvic junction obstruction will be compared, regarding partial renal function.

Condition Intervention
Unilateral Ureteropelvic Junction Obstruction Procedure: Pyeloplasty

Study Type: Interventional
Study Design: 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

Further study details as provided by University Hospital, Essen:

Primary Outcome Measures:
  • partial renal function

Estimated Enrollment: 240
Study Start Date: March 2007
  Eligibility

Information from the National Library of Medicine

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

Locations
Germany
University Hospital of Essen, Department of Pediatric Nephrology Not yet recruiting
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 Not yet recruiting
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
Principal Investigator: Herbert Rübben, Prof. University Hospital, Essen
Principal Investigator: Peter Hoyer, Prof. University Hospital, Essen
  More Information

ClinicalTrials.gov Identifier: NCT00444431     History of Changes
Other Study ID Numbers: 2005-004090-13
First Submitted: March 5, 2007
First Posted: March 7, 2007
Last Update Posted: March 7, 2007
Last Verified: March 2007

Additional relevant MeSH terms:
Hydronephrosis
Ureteral Obstruction
Multicystic Dysplastic Kidney
Kidney Diseases
Urologic Diseases
Ureteral Diseases
Urogenital Abnormalities
Kidney Diseases, Cystic
Congenital Abnormalities