Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in Renal Calculi

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-02-28

Brief Summary

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Flexible ureteroscopy is a recent procedure to treat renal stone. Extracorporeal shockwave lithotripsy was the gold standard treatment for calculi between 5 and 20 mm. In literature, the two procedures are available to treat these stones with a good stone free rate. There is no prospective randomized study comparing these two treatments. Our study will define with a good level of evidence which technique is the best with regard to the stone free rate, secondary procedure rate and adverse effect.

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Detailed Description

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Conditions

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Extracorporeal Shockwave Lithotripsy, Flexible Ureteroscopy

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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Extracorporeal shockwave lithotripsy

stone treatment using electroconductive technology

Group Type ACTIVE_COMPARATOR

extracorporeal shockwave lithotripsy

Intervention Type PROCEDURE

The lithotriptor is use with 1,1 Hz frequency and stop when patient get 1000 joules of energy or if there is a problem with tolerance of this treatment or if stone is broken

Flexible ureteroscopy

intra renal retrograde surgery with or without laser and stone extraction

Group Type ACTIVE_COMPARATOR

flexible ureteroscopy

Intervention Type PROCEDURE

Flexible ureteroscopy will be use for 120 min max to treat renal stone. Laser, access sheath, baskets can be use to perform the technique.

Interventions

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flexible ureteroscopy

Flexible ureteroscopy will be use for 120 min max to treat renal stone. Laser, access sheath, baskets can be use to perform the technique.

Intervention Type PROCEDURE

extracorporeal shockwave lithotripsy

The lithotriptor is use with 1,1 Hz frequency and stop when patient get 1000 joules of energy or if there is a problem with tolerance of this treatment or if stone is broken

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient with 5 to 20 mm renal stone
* Age ≥ 18 years old
* Patient agreement signed
* BMI \< 35
* Contraception

Exclusion Criteria

* Pregnancy
* Severe musculoskeletal deformities
* Renal artery or aorta aneurysm
* Pacemaker
* Anesthesia contra indication
* Psychiatric trouble or law protection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No