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NCT02658942 Clinical Trial

Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones

Renal Stones Clinical Trial

Official title:
Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones: A Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02658942
Other study ID # 62120
Secondary ID
Status Completed
Phase N/A
First received January 14, 2016
Last updated January 19, 2016
Start date May 2010
Est. completion date May 2015

Study information
Verified date January 2016
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority Egypt: Ministry of Higher Education
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date May 2015
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Ureteroscopy
In Group A patients, Karl Storz Flex-X 7.5, FURS with a 365 µm laser fiber.
• Shockwave lithotripsy
In Group B patients, a Siemens Lithostar Lithotriptor

Locations
Country Name City State
Egypt Cairo University Hospitals Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Stone free rate no stone fragments or having fragments <3mm 3 months No
Secondary Complications Bleeding Infection Pain obstruction renal or ureteric injury UTI Fever 3 years Yes
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