Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones

Not Applicable

Completed

• Conditions: Renal Stones
• Interventions: Procedure: Shockwave lithotripsy; Procedure: Ureteroscopy

• Registration Number: NCT02658942
• Lead Sponsor: Cairo University

Brief Summary

to assess safety, efficacy of Flexible ureteroscopy (FURS) holmium:YAG laser lithotripsy (LL) compared to extracorporeal shockwave lithotripsy (ESWL) in management of lower calyceal stones (LC) stones.

Detailed Description

to assess stone free rate, number of sessions and complications of flexible ureteroscopy holmium:YAG laser lithotripsy compared to extracorporeal shockwave lithotripsy in the management of lower calyceal stones less than 2 cm in size.

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2012-05
• Study Completion: 2015-05
• Status Verified: 2016-01
• Study First Submitted: 2016-01-14
• Study First Submitted QC: 2016-01-19
• Last Update Submitted: 2016-01-19
• Study First Posted: 2016-01-20
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• unilateral
• radiopaque stone(s)
• < 2 cm
• located in the lower calyx.

Exclusion Criteria

• Bleeding tendency
• distal obstruction
• Anomalies of the urinary tract
• Solitary kidney

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shockwave lithotripsy	Shockwave lithotripsy	Intervention: Shockwave lithotripsy for lithotripsy of lower calyceal stones using Siemens Lithostar Lithotriptor
Ureteroscopy	Ureteroscopy	Intervention: Flexible ureteroscopy for removal of lower calyceal stones using holmium:YAG laser lithotripsy

Primary Outcome Measures

Name	Time	Method
Stone free rate	3 months	no stone fragments or having fragments \<3mm

Secondary Outcome Measures

Name	Time	Method
Complications	3 years	Bleeding Infection Pain obstruction renal or ureteric injury UTI Fever

Trial Locations

Locations (1)

Cairo University Hospitals; 🇪🇬 Cairo, Egypt