NCT00739284

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2008

Completed
Last Updated

August 21, 2008

Status Verified

August 1, 2008

Enrollment Period

Same day

First QC Date

August 20, 2008

Last Update Submit

August 20, 2008

Conditions

Kidney Disease

Keywords

preferredproceduredrainageobstructedkidneystone

Outcome Measures

Primary Outcomes (1)

  • quality of life

Interventions

nephrostomy tube and ureteral stentDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • fever (above 38c)
  • A rise in creatine to above 1.5
  • Pain resistent to multiple analgetic treatments

You may not qualify if:

  • Patients with medical condition that prevent the use of one of the procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin medical center

Petah Tikva, Israel

RECRUITING

MeSH Terms

Conditions

Kidney DiseasesCalculi

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Shay Golan, MD

CONTACT

972-3-9376560shayg@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2008

First Posted

August 21, 2008

Study Start

August 1, 2008

Primary Completion

August 1, 2008

Last Updated

August 21, 2008

Record last verified: 2008-08

Locations

IL(1)