Back to resultsA Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)
Primary Purpose
Kidney Disease
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
nephrostomy tube and ureteral stent
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Disease focused on measuring preferred, procedure, drainage, obstructed, kidney, stone
Eligibility Criteria
Inclusion Criteria: Patient suffering from obstructed kidney by a stone and at least one of these situations:
- fever (above 38c)
- A rise in creatine to above 1.5
- Pain resistent to multiple analgetic treatments
Exclusion Criteria:
- Patients with medical condition that prevent the use of one of the procedures
Sites / Locations
- Rabin medical centerRecruiting
Outcomes
Primary Outcome Measures
quality of life
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00739284
Brief Title
A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney
Acronym
JJVsPCN08
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2008 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Kidney obstruction might be caused by a stone in the urinary tract. In case of accompanying fever or renal failure, an urgent drainage might be needed. This can be done either by placing an ureteral stent or a nephrotomy tube. Only limited number of studies examined the question which of the two is preferred. A debate exist regarding the effectiveness of each procedure to improve symptoms, renal function and treating an infection. Our goal is to resolve this debate and to state whether one way is preferred on the other.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Disease
Keywords
preferred, procedure, drainage, obstructed, kidney, stone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
nephrostomy tube and ureteral stent
Primary Outcome Measure Information:
Title
quality of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient suffering from obstructed kidney by a stone and at least one of these situations:
fever (above 38c)
A rise in creatine to above 1.5
Pain resistent to multiple analgetic treatments
Exclusion Criteria:
Patients with medical condition that prevent the use of one of the procedures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shay Golan, MD
Phone
972-3-9376560
Email
shayg@clalit.org.il
Facility Information:
Facility Name
Rabin medical center
City
Petach Tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shay Golan, MD
Phone
972-3-9376560
Email
shayg@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Shay Golan, MD
12. IPD Sharing Statement
Learn more about this trial
A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney
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