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
Recruitment status was Not yet recruiting
Sponsor:
University Hospital, Essen
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
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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 |
Further study details as provided by University Hospital, Essen:
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
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 May 21, 2013