NCT00546208

Brief Summary

This observational study is aimed at exploring bladder function following temporary unilateral low loop cutaneous ureterostomy carried out in newborns suffering from severe congenital hydro-ureteronephrosis

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
Last Updated

March 17, 2008

Status Verified

March 1, 2008

First QC Date

October 17, 2007

Last Update Submit

March 13, 2008

Conditions

Bladder Function

Keywords

bladder functioncutaneous ureterostomyhydronephrosis

Study Arms (1)

1

adolescents and young adults who underwent, as newborns, unilateral low loop cutaneous ureterostomy for severe bilateral hydro-ureteronephrosis, and that, afterwards, underwent stomal closure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adolescents and adults who had been operated in our institution for severe bilateral congenital hydro-ureteronephrosis

You may qualify if:

  • Living patients
  • Bilateral functioning kidneys
  • Unilateral ureteral cutaneous diversion

You may not qualify if:

  • Dead patients
  • Single kidney
  • High percutaneous ureteral diversion (e.g: cutaneous pyelostomies, bilateral cutaneous urinary diversion)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chaim Sheba Medical Center, Tel Hashomer

Ramat Gan, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Hydronephrosis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Dorit E Zilberman, MD

    The Chaim Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorit E Zilberman, MD

CONTACT

+97235302231dorit.zilberman@sheba.health.gov.il

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 17, 2007

First Posted

October 18, 2007

Study Start

February 1, 2008

Last Updated

March 17, 2008

Record last verified: 2008-03

Locations

IL(1)