Ureteroscopy With and Without Safety Guidewire

March 31, 2015 updated by: Helse-Bergen HF

Ureteroscopy With and Without Safety Guidewire:. A Prospective, Randomized Study of the Results of Endoscopic Treatment of Urolithiasis.

The purpose of this study is to investigate the impact of a safety guidewire (SGW) on the results of ureteroscopy for urolithiasis.

Study hypothesis: Routine use of SGW has no impact on the results of ureteroscopic treatment of urolithiasis.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The use of SGW is generally recommended at any ureteroscopic procedure in order to facilitate the introduction of the endoscope and to secure placement of internal tubes for drainage of urine after the procedure.

However, SGW may be an obstacle to efficient disintegration and retraction of calculi in the narrow ureter.

The intention of this study is to compare the results of endoscopic stone treatment with and without the use of SGW.

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

  • Norway
      • Bergen, Norway, 5021
        • Helse Bergen HF, Haukeland University Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with urolithiasis planned for ureterorenoscopic treatment

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B - without SGW
Ureteroscopy without SGW in place.
Procedure: Ureteroscopy with and without safety guidewire
In study arm A - with SGW, endoscopic treatment is performed with a safety guidewire in place. In study arm B - without SGW, the ureteroscopy is performed without SGW.
Active Comparator: A - with SGW
Ureteroscopy with SGW in place.
Procedure: Ureteroscopy with and without safety guidewire
In study arm A - with SGW, endoscopic treatment is performed with a safety guidewire in place. In study arm B - without SGW, the ureteroscopy is performed without SGW.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stone free-rate
Time Frame: 3 months after treatment
3 months after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital stay
Time Frame: Up to 1 week after the operation
Up to 1 week after the operation
Complication rate
Time Frame: Until 3 months after the procedure
Until 3 months after the procedure
Operating time
Time Frame: Up to 1 day after the surgery
Up to 1 day after the surgery

Collaborators and Investigators

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

Sponsor

Helse-Bergen HF

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

May 1, 2010

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

May 4, 2010

First Submitted That Met QC Criteria

May 4, 2010

First Posted (Estimate)

May 5, 2010

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102.09 (REK) - 3 (Other Identifier: The National Committees for Research Ethics in Norway)
  • 21835 (NSD) - 3 (Other Identifier: Norway: Norwegian Social Science Data Services)

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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