Management of Fragments During Ureteroscopy

February 9, 2009 updated by: The Chaim Sheba Medical Center

Should we Strive for Absolute "Stone Freedom" While Performing Holmium Laser Lithotripsy for Ureteral Stones? A Randomized Controlled Trial.

The purpose of this study is to study the outcome of patients after ureteroscopy in which all fragments remaining after holmium laser lithotripsy were retrieved compared to those where small, insignificant fragments were left for spontaneous passage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • Ramat Gan
      • Tel Hashomer, Ramat Gan, Israel, 52621
        • The Chaim Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with ureteral stones suitable for endoscopic treatment

Exclusion Criteria:

  • presence of ipsilateral kidney stones
  • known ureteral stricture
  • previous placement of ureteral stent
  • use of drugs with known activity on smooth ureteral muscle
  • unwillingness or impossibility to return for follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B
Experimental group: patients in whom "stone dust" was left for spontaneous elimination
Procedure: Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragment
Other: A
Control group: Patients in whom all fragments resulting from laser lithotripsy of ureteral stones were actively retrieved
Procedure: Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
unplanned medical visits
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital Admissions, need for pain killers, time to complete recovery
Time Frame: 60 days
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Chaim Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

March 12, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (Estimate)

March 18, 2008

Study Record Updates

Last Update Posted (Estimate)

February 10, 2009

Last Update Submitted That Met QC Criteria

February 9, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4638

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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