Trial document




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  DRKS00010837

Trial Description

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Title

Retrospective evaluation of radiation exposure during flexible ureteroscopy

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Trial Acronym

not applicable

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URL of the Trial

[---]*

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Brief Summary in Lay Language

A data analysis which evaluates the impact of a standardized protocol in the treatment of renal stones (10-20 mm) with flexible ureteroscopy on applied X-ray radiation will be performed.

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Brief Summary in Scientific Language

In this retrospective study we evaluate the impact of a standardized treatment protocol during flexible ureteroscopy for renal stones between 10-20 mm on the radiation exposure for the patient and the OR-stuff.

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Organizational Data

  •   DRKS00010837
  •   2016/07/18
  •   [---]*
  •   yes
  •   Approved
  •   60/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   N20.0 -  Calculus of kidney
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Interventions/Observational Groups

  •   one arm, retrospective study:
    Retrospective evalutation of fluoroscopy time and radiation dose (primary endpoints) of all flexible ureteroscopies performed for renal stones between 10-20 mm.
    Secondary endpoints: Stone-free rate and complications.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

fluoroscopy time and radiation dose

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Secondary Outcome

Stone-free rate, complications, retreatment rate

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/07/25
  •   174
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Stone treatment with flexible ureteroscopy for renal stones between 10-20mm by the same two urologists

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Exclusion Criteria

no exclusion criteria, see inclusion criteria

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Addresses

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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
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
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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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    • Medizinische Fakultät, Universität Freiburg
    • Hugstetter Str. 49
    • 79106  Freiburg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2017/06/30
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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.