Unilateral Cutaneous Ureterostomy - Long Term Follow up | NCT00546208

Studies
Unilateral Cutaneous Ureterostomy - Long Term Follow up

NCT00546208

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Mar 17, 2008Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Bladder Function

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 17, 2007

First Submission Date that Met QC Criteria

Oct 17, 2007

First Posted Date

Oct 18, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2008

Last Update Posted Date

Mar 17, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Living patients
Bilateral functioning kidneys
Unilateral ureteral cutaneous diversion

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dorit E Zilberman, MD	Contact	+97235302231		dorit.zilberman@sheba.health.gov.il

Overall Officials

Name	Affiliation	Role
Dorit E Zilberman, MD	The Chaim Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Chaim Sheba Medical Center, Tel Hashomer	Recruiting	Ramat Gan		52621	Israel

Condition Browse Module

MeSH Terms

ID	Term
D006869	Hydronephrosis

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided