Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones

NCT ID: NCT02658942

Last Updated: 2016-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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Renal Stones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ureteroscopy

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

Group Type ACTIVE_COMPARATOR

Ureteroscopy

Intervention Type PROCEDURE

In Group A patients, Karl Storz Flex-X 7.5, FURS with a 365 µm laser fiber.

Shockwave lithotripsy

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

Group Type ACTIVE_COMPARATOR

Shockwave lithotripsy

Intervention Type PROCEDURE

In Group B patients, a Siemens Lithostar Lithotriptor

Interventions

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Ureteroscopy

In Group A patients, Karl Storz Flex-X 7.5, FURS with a 365 µm laser fiber.

Intervention Type PROCEDURE

Shockwave lithotripsy

In Group B patients, a Siemens Lithostar Lithotriptor

Intervention Type PROCEDURE

Other Intervention Names

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Flexible Ureteroscopy ESWL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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mohammed said elsheemy

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed S ElSheemy, M.D

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Cairo University Hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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62120

Identifier Type: -

Identifier Source: org_study_id

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