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Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02658942
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
mohammed said elsheemy, Cairo University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Renal Stones Procedure: Ureteroscopy Procedure: Shockwave lithotripsy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones: A Prospective Randomized Study
Study Start Date : May 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2015

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Ureteroscopy
Intervention: Flexible ureteroscopy for removal of lower calyceal stones using holmium:YAG laser lithotripsy
 Procedure: Ureteroscopy
In Group A patients, Karl Storz Flex-X 7.5, FURS with a 365 µm laser fiber.
Other Name: Flexible Ureteroscopy
Active Comparator: Shockwave lithotripsy
Intervention: Shockwave lithotripsy for lithotripsy of lower calyceal stones using Siemens Lithostar Lithotriptor
 Procedure: Shockwave lithotripsy
In Group B patients, a Siemens Lithostar Lithotriptor
Other Name: ESWL


Outcome Measures
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Primary Outcome Measures :
  1. Stone free rate [ Time Frame: 3 months ]
    no stone fragments or having fragments <3mm


Secondary Outcome Measures :
  1. Complications [ Time Frame: 3 years ]
    Bleeding Infection Pain obstruction renal or ureteric injury UTI Fever


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658942


Locations
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Egypt
Cairo University Hospitals
Cairo, Egypt, 12222
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Mohammed S ElSheemy, M.D Cairo University
More Information
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Responsible Party: mohammed said elsheemy, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT02658942    
Other Study ID Numbers: 62120
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Keywords provided by mohammed said elsheemy, Cairo University:
renal stones
lower calyx
Ureteroscopy
Shockwave lithotripsy
 Holmium laser
Adult
Kidney
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
 Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi