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:

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: 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


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

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 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
Study First Received:	March 5, 2007
Last Updated:	March 5, 2007

Additional relevant MeSH terms:


Hydronephrosis Ureteral Obstruction Multicystic Dysplastic Kidney Kidney Diseases Urologic Diseases	Ureteral Diseases Urogenital Abnormalities Kidney Diseases, Cystic Congenital Abnormalities

ClinicalTrials.gov processed this record on September 21, 2017

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