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Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT02658942
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
60
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Ureteroscopy
  • Procedure: Shockwave lithotripsy
 N/A

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

Study Type:
Interventional
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 1, 2010
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

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 Names:
  • 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 Names:
  • ESWL

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Stone free rate [3 months]

      no stone fragments or having fragments <3mm

    Secondary Outcome Measures

    1. Complications [3 years]

      Bleeding Infection Pain obstruction renal or ureteric injury UTI Fever

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Cairo University Hospitals Cairo Egypt 12222

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Mohammed S ElSheemy, M.D, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    mohammed said elsheemy, Assistant professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT02658942
    Other Study ID Numbers:
    • 62120
    First Posted:
    Jan 20, 2016
    Last Update Posted:
    Jan 20, 2016
    Last Verified:
    Jan 1, 2016
    Keywords provided by mohammed said elsheemy, Assistant professor, Cairo University
    renal stones
    lower calyx
    Ureteroscopy
    Shockwave lithotripsy
    Holmium laser
    Adult
    Kidney
    Additional relevant MeSH terms:
    Kidney Calculi
    Nephrolithiasis
    Calculi

    Study Results

    No Results Posted as of Jan 20, 2016