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 because the information has not been verified recently.
Verified March 2007 by University Hospital, Essen.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Hospital, Essen
ClinicalTrials.gov Identifier:
NCT00444431
First received: March 5, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  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: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Essen:

Primary Outcome Measures:
  • partial renal function

Estimated Enrollment: 240
Study Start Date: March 2007
  Eligibility

Ages Eligible for Study:   4 Months to 6 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444431

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

Locations
Germany
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.         
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.         
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

No publications provided

ClinicalTrials.gov Identifier: NCT00444431     History of Changes
Other Study ID Numbers: 2005-004090-13
Study First Received: March 5, 2007
Last Updated: March 5, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on September 29, 2014