NCT00444431

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2007

Completed
Last Updated

March 7, 2007

Status Verified

March 1, 2007

First QC Date

March 5, 2007

Last Update Submit

March 5, 2007

Conditions

Unilateral Ureteropelvic Junction Obstruction

Outcome Measures

Primary Outcomes (1)

  • partial renal function

Interventions

PyeloplastyPROCEDURE

Eligibility Criteria

Age4 Months - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital of Essen, Department of Pediatric Nephrology

Essen, North Rhine-Westphalia, 45122, Germany

Location

University Hospital of Essen, Department of Urology

Essen, North Rhine-Westphalia, 45122, Germany

Location

Study Officials

  • Herbert Rübben, Prof.

    University Hospital, Essen

    PRINCIPAL INVESTIGATOR

  • Peter Hoyer, Prof.

    University Hospital, Essen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Achim Rose, Md

CONTACT

00492017233221roseachim@web.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 5, 2007

First Posted

March 7, 2007

Study Start

March 1, 2007

Last Updated

March 7, 2007

Record last verified: 2007-03

Locations

DE(2)