MedPath

Ureteroscopy With and Without Safety Guidewire

Not Applicable
Withdrawn
Conditions
Urolithiasis
Interventions
Procedure: Ureteroscopy with and without safety guidewire
Registration Number
NCT01117688
Lead Sponsor
Helse-Bergen HF
Brief Summary

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.

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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • Patients with urolithiasis planned for ureterorenoscopic treatment
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
A - with SGWUreteroscopy with and without safety guidewireUreteroscopy with SGW in place.
B - without SGWUreteroscopy with and without safety guidewireUreteroscopy without SGW in place.
Primary Outcome Measures
NameTimeMethod
Stone free-rate3 months after treatment
Secondary Outcome Measures
NameTimeMethod
Operating timeUp to 1 day after the surgery
Hospital stayUp to 1 week after the operation
Complication rateUntil 3 months after the procedure

Trial Locations

Locations (1)

Helse Bergen HF, Haukeland University Hospital

🇳🇴

Bergen, Norway

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