Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00016617

Trial Description

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Title

Radiation Exposure during Flexible UreteroScopy - a prospective evaluation

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Trial Acronym

REFUSE - Radiation Exposure during Flexible UreteroScopy

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URL of the Trial

http://not applicable

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Brief Summary in Lay Language

Investigation of the effect of preoperative training and briefing of the flexible ureteroscopy performing surgeon with regard to applied x-ray during ureteroscopy.

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Brief Summary in Scientific Language

This is a 2-phase multicenter study to assess radiation exposure in flexible ureteroscopy (fURS) in the treatment of kidney stones. In the 1st phase, the retrospective analysis of radiation exposure will be performed on fURS. The collected will be used as a baseline data for the following prospective phase 2. Before the beginning of phase 2, the surgeons are informed about the planned recording of the radiation exposure caused by them during the operation into a study. The aim of this study is to demonstrate that the more conscious use of X-rays in the context of fURS can reduce the overall exposure for the patient and the OP staff. This would be associated with a reduction of the dose-dependent risk of radiation-related diseases and malignancies.

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Organizational Data

  •   DRKS00016617
  •   2019/02/20
  •   [---]*
  •   yes
  •   Approved
  •   16-101-0064, Ethikkommission an der Universität Regensburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   N20 -  Calculus of kidney and ureter
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Interventions/Observational Groups

  •   Retrospective Study arm (previous performed fURS): fURS (flexible ureteroscopy) for treatment of kidney stones.
  •   Prospective study arm (fURS after surgeon X-ray briefing): fURS after surgeon X-ray briefing.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Historical
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Fluoroscopy time, dose-area product
- evaluated and display after fURS by the used X-ray machine.

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Secondary Outcome

Surgical outomce: Stone clearance, complications according to Clavien-Dindo

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/11/29
  •   300
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

flexible ureteroscopy of kidney stone(s) with application of laserlithotripsy

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Exclusion Criteria

Children, no performed laserlithotripsy, anomaly of the urinary tract

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum FreiburgDepartment ChirurgieKlilnik für Urologie
    • Mr.  Dr. med.  Simon  Hein 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgDepartment ChirurgieKlilnik für Urologie
    • Mr.  Dr. med.  Simon  Hein 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgDepartment ChirurgieKlilnik für Urologie
    • Mr.  Dr. med.  Simon  Hein 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum FreiburgDepartment ChirurgieKlilnik für Urologie
    • Mr.  Dr. med.  Simon  Hein 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/12/31
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.