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Completed

NCT Number: NCT02645058

RIRS Versus ESWL for the Treatment of Renal Stones

To evaluate the effectiveness of RIRS (retrograde intrarenal surgery) and ESWL (extracorporeal shockwaves lithotripsy) in the treatment of renal stone ranging form 6 to 20 mm size.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urology, University of Turin

Turin, 10126, Italy

About this study

European urological guidelines consider RIRS and ESWL the treatments of choice for renal stones < 20 mm. RIRS is a endoscopic surgery which allows to rich the kidney from the ureter. A flexible ureteroscope is used for these kind of procedure. Through this device a laser fiber (Holmium laser) is used to treat the stones. After that, small fragments can be removed with a basket. In some cases, according to intraoperative findings, a ureteral stent can be push in the kidney to help the drainage of the kidney. ESWL is a procedure which allows to treat the stones by shock waves generated by a specific machine which work in direct contact with the skin of the patients (extracorporeal). Shockwaves pass all the tissues and finally reach the stones. Such energy allows to break the stones in small fragments, that wll be spontaneously passed by the patients. Specific parameters of these treatments are discussed in "Arms and Interventions". Many studies demonstrated high success rate of RIRS and this technique is becoming more and more adopt. One study demonstrated better outcomes of RIRS versus ESWL, but only for renal stones located in the inferior calices and smaller then 10 mm. There are not other studies comparing the two procedures and there are not proofs that RIRS ensures better outcomes for other renal stones (neither for size nor for location).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • renal stone measuring 6 to 20 mm
  • signing informed consent
  • WHO performance status 0-2

Exclusion criteria

  • Other stone >5 mm
  • concomitant ureteral stones
  • BMI > 35
  • severe coagulopathy
  • impossibility to sign informed consent
  • pregnancy
  • age < 18 years old or > 85

Treatment and study plan

RIRS

Procedure

Treatment by ureterorenoscopy (RIRS) and laser lithotripsy

ESWL

Procedure

Treatment by extracorporeal shock waves lithotripsy

Rigid and flexible ureteroscope

Device

Lithotripter

Device

holmium laser

Device

Basket for fragment removal

Device

General or spinal anesthesia

Procedure

Intravenous pain medication

Drug

If required by the patient

x-ray

Device

To focus the stone

Ultrasound

Device

To focus the stone

Primary outcomes

  1. Number of patients stone free SFR 4

    Time frame: 1 month from treatment

    Patients with residual fragments < 5 mm after treatment

Secondary outcomes

  1. Number of patients stone free SFR 0

    Time frame: 1 month from treatment

    Patients with no residual fragments after treatment

  2. Number of patients stone free SFR 4

    Time frame: 6 months after the treatment

    Patients with residual fragments < 5 mm after treatment

  3. Number of patients stone free SFR 0

    Time frame: 6 months after the treatment

    Patients with no residual fragments after treatment

  4. Number of patients stone free SFR 4

    Time frame: 1 year after the treatment

    Patients with residual fragments < 5 mm after treatment

  5. Number of patients stone free SFR 0

    Time frame: 1 year after the treatment

    Patients with no residual fragments after treatment

  6. rate of complications

    Time frame: within 1 month form treatment

    number of complications after treatment

  7. rate of further treatment needed

    Time frame: within 1 year

    number of retreatment

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Retrograde Intrarenal Surgery (RIRS) Versus Extracorporeal Shock Waves Lithotripsy (ESWL) for the Treatment of Renal Stones Measuring 6-20 mm: A Prospective Randomized Study

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jan 1, 2016
Registry last updated
May 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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