Does a Safety Guidewire Increase the Forces Needed to Move the Ureteroscope up and Down the Ureter?

Not Applicable

Completed

• Conditions: Ureteroscopy
• Interventions: Procedure: Ureteroscopy with and without safety guidewire

• Registration Number: NCT01117701
• Lead Sponsor: Helse-Bergen HF

Brief Summary

The purpose of this study is to investigate to forces needed to passage the ureteroscope up and down the ureter with and without a safety guidewire in place.

Detailed Description

Ureteroscopy may damage the ureter, and the complication risk is influenced by the forces needed to move the ureteroscope up and down the ureter.

Although a safety guidewire (SGW) is commonly recommended in order to reduce the complication rate it may well be that the SGW itself may inhibit the passage of the ureteroscope due to increased friction.

The forces needed to move the ureteroscope in the ureter have not been investigated properly.

The intention in this study is to measure the forces needed to advance and withdraw the ureteroscope in the ureter with and without the SGW in place.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-04
• Study First Submitted QC: 2010-05-04
• Study First Posted: 2010-05-05
• Status Verified: 2011-06
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients planned for endoscopic kidney stone treatment

Exclusion Criteria

• Known pathology in the ureter

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A - with SGW	Ureteroscopy with and without safety guidewire	Measurement of the forces needed to passage the ureteroscope in the ureter with a SGW in place.
B - without SGW	Ureteroscopy with and without safety guidewire	Measurement of the forces needed to passage the ureteroscope in the ureter without a SGW in place.

Primary Outcome Measures

Name	Time	Method
The force needed to passage the ureteroscope up and down in the ureter with and without SGW.	1 day	The force is measured by a digital force-meter device. The force measured is scaled in Newton. The results are available immediately after each measurement.

Trial Locations

Locations (1)

Helse Bergen HF, Haukeland University Hospital; 🇳🇴 Bergen, Norway