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

Primary Purpose

Unilateral Ureteropelvic Junction Obstruction

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Pyeloplasty
Sponsored by
University Hospital, Essen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unilateral Ureteropelvic Junction Obstruction

Eligibility Criteria

4 Months - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Essen, Department of Pediatric Nephrology
  • University Hospital of Essen, Department of Urology

Outcomes

Primary Outcome Measures

partial renal function

Secondary Outcome Measures

Full Information

First Posted
March 5, 2007
Last Updated
March 5, 2007
Sponsor
University Hospital, Essen
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1. Study Identification

Unique Protocol Identification Number
NCT00444431
Brief Title
Ureteropelvic Junction Obstruction in Early Childhood: Comparison of Surgical Therapy and Surveillance. A Prospective, Randomized, Controlled Multi-Center Study
Acronym
TOKU
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 Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Essen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Ureteropelvic Junction Obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Pyeloplasty
Primary Outcome Measure Information:
Title
partial renal function

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Achim Rose, Md
Phone
00492017233221
Email
roseachim@web.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert Rübben, Prof.
Organizational Affiliation
University Hospital, Essen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Hoyer, Prof.
Organizational Affiliation
University Hospital, Essen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Essen, Department of Pediatric Nephrology
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Hoyer, Prof.
Phone
00492017232810
Email
peter.hoyer@uni-essen.de
First Name & Middle Initial & Last Name & Degree
Peter Hoyer, Prof.
Facility Name
University Hospital of Essen, Department of Urology
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Herbert Rübben, Prof.
Phone
00492017233211
Email
herbert.ruebben@uni-essen.de
First Name & Middle Initial & Last Name & Degree
Herbert Rübben, Prof.

12. IPD Sharing Statement

Learn more about this trial

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

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