Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones

January 19, 2016 updated by: mohammed said elsheemy, Cairo University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12222
        • Cairo University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone free rate
Time Frame: 3 months
no stone fragments or having fragments <3mm
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 3 years
Bleeding Infection Pain obstruction renal or ureteric injury UTI Fever
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 14, 2016

First Submitted That Met QC Criteria

January 19, 2016

First Posted (Estimate)

January 20, 2016

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 19, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 62120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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