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

March 5, 2007 updated by: University Hospital, Essen

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45122
        • University Hospital of Essen, Department of Pediatric Nephrology
      • Essen, Nordrhein-Westfalen, Germany, 45122
        • University Hospital of Essen, Department of Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 6 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
partial renal function

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Essen

Investigators

  • Principal Investigator: Herbert Rübben, Prof., University Hospital, Essen
  • Principal Investigator: Peter Hoyer, Prof., University Hospital, Essen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Registration Dates

First Submitted

March 5, 2007

First Submitted That Met QC Criteria

March 5, 2007

First Posted (ESTIMATE)

March 7, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 7, 2007

Last Update Submitted That Met QC Criteria

March 5, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-004090-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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