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Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones

Primary Purpose

Renal Stones

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ureteroscopy
Shockwave lithotripsy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Stones focused on measuring renal stones, lower calyx, Ureteroscopy, Shockwave lithotripsy, Holmium laser, Adult, Kidney

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cairo University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ureteroscopy

Shockwave lithotripsy

Arm Description

Intervention: Flexible ureteroscopy for removal of lower calyceal stones using holmium:YAG laser lithotripsy

Intervention: Shockwave lithotripsy for lithotripsy of lower calyceal stones using Siemens Lithostar Lithotriptor

Outcomes

Primary Outcome Measures

Stone free rate
no stone fragments or having fragments <3mm

Secondary Outcome Measures

Complications
Bleeding Infection Pain obstruction renal or ureteric injury UTI Fever

Full Information

First Posted
January 14, 2016
Last Updated
January 19, 2016
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02658942
Brief Title
Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones
Official Title
Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones: A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Stones
Keywords
renal stones, lower calyx, Ureteroscopy, Shockwave lithotripsy, Holmium laser, Adult, Kidney

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ureteroscopy
Arm Type
Active Comparator
Arm Description
Intervention: Flexible ureteroscopy for removal of lower calyceal stones using holmium:YAG laser lithotripsy
Arm Title
Shockwave lithotripsy
Arm Type
Active Comparator
Arm Description
Intervention: Shockwave lithotripsy for lithotripsy of lower calyceal stones using Siemens Lithostar Lithotriptor
Intervention Type
Procedure
Intervention Name(s)
Ureteroscopy
Other Intervention Name(s)
Flexible Ureteroscopy
Intervention Description
In Group A patients, Karl Storz Flex-X 7.5, FURS with a 365 µm laser fiber.
Intervention Type
Procedure
Intervention Name(s)
Shockwave lithotripsy
Other Intervention Name(s)
ESWL
Intervention Description
In Group B patients, a Siemens Lithostar Lithotriptor
Primary Outcome Measure Information:
Title
Stone free rate
Description
no stone fragments or having fragments <3mm
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Complications
Description
Bleeding Infection Pain obstruction renal or ureteric injury UTI Fever
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed S ElSheemy, M.D
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University Hospitals
City
Cairo
ZIP/Postal Code
12222
Country
Egypt

12. IPD Sharing Statement

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Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones

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