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

NCT ID: NCT00444431

Last Updated: 2007-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Unilateral Ureteropelvic Junction Obstruction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pyeloplasty

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

4 Months

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Essen

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Herbert Rübben, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Essen

Peter Hoyer, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Essen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital of Essen, Department of Pediatric Nephrology

Essen, North Rhine-Westphalia, Germany

Site Status

University Hospital of Essen, Department of Urology

Essen, North Rhine-Westphalia, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Achim Rose, Md

Role: CONTACT

00492017233221

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Peter Hoyer, Prof.

Role: primary

00492017232810

Herbert Rübben, Prof.

Role: primary

00492017233211

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2005-004090-13

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.