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Unilateral Cutaneous Ureterostomy - Long Term Follow up (ureterostomy)

This study is currently recruiting participants.
Verified by Sheba Medical Center, March 2008

Sponsored by: Sheba Medical Center
Information provided by: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00546208
  Purpose

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


Condition
Bladder Function

U.S. FDA Resources

Study Type:   Observational
Study Design:   Other, Prospective
Official Title:   Bladder Function Following Temporary Unilateral Cutaneous Ureterostomy - Long Term Follow up

Further study details as provided by Sheba Medical Center:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   30
Study Start Date:   February 2008

Groups/Cohorts
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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

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


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)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546208

Contacts
Contact: Dorit E Zilberman, MD     +97235302231     dorit.zilberman@sheba.health.gov.il    

Locations
Israel
The Chaim Sheba Medical Center, Tel Hashomer     Recruiting
      Ramat Gan, Israel, 52621
      Contact: Dorit E Zilberman, MD     +973-3-5302231     dorit.zilberman@sheba.health.gov.il    
      Sub-Investigator: Yoram Mor, MD            

Sponsors and Collaborators
Sheba Medical Center

Investigators
Principal Investigator:     Dorit E Zilberman, MD     The Chaim Sheba Medical Center    
  More Information

Responsible Party:   Urology Department, Chaim Sheba Medical Center ( Dorit Zilberman )
Study ID Numbers:   SHEBA-07-4838-DZ-CTIL
First Received:   October 17, 2007
Last Updated:   March 13, 2008
ClinicalTrials.gov Identifier:   NCT00546208
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
bladder function  
cutaneous ureterostomy  
hydronephrosis  

Study placed in the following topic categories:
Hydronephrosis

ClinicalTrials.gov processed this record on September 05, 2008




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