Trial document




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  DRKS00009745

Trial Description

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Title

Longterm follow-up of 100 patients treated by flexible ureteroscopy

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Trial Acronym

LFRIRS

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URL of the Trial

http://N/A

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Brief Summary in Lay Language

In this retrospective follow-up study we assess stone-related events (SRE) requiring retreatment in patients treated with retrograde intrarenal surgery (RIRS) for renal calculi between 2009-2011. Incidences of SREs will be evaluated in respect to potential risk factors including residual gravel left behind during initial treatment.

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Brief Summary in Scientific Language

Current guidelines consider three different treatment modalities of renal calculi: shock wave lithotripsy (SWL), percutaneous nephrolithotomy (PNL), and flexible retrograde intrarenal surgery (RIRS). Recent technical improvements and excellent stone free rates have led to an increase of performed RIRS. Herein, renal calculi are fragmented using laser lithotripsy. Herafter, fragments are retrieved using baskets. However, small fragments can not be retrieved and so called 'residual fragments' may be left after treatment. Current data regarding the fate of residual fragments and their impact on the patients' future course are scarce.
In the current retrospective follow-up study we assess stone-related events (SRE) requiring retreatment in patients treated with retrograde intrarenal surgery (RIRS) for renal calculi between 2009-2011. Incidences of SREs will be evaluated in respect to potential risk factors including residual fragments left behind during initial treatment.
Primary outcome is the incidence of SREs (medical or surgical treatment). Secondary outcomes include side of SRE, time to SRE, and late complications. Retrospective analysis of potential risk factors include residual gravel after initial treatment, high stone burden, lower pole stones, high-risk stone formers (HRSF), and obesity.
The follow-up data may improve the avaiable evidence regarding long-term outcomes and potential risk factors for reoccurrence of stone-related events.

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Organizational Data

  •   DRKS00009745
  •   2015/12/18
  •   [---]*
  •   yes
  •   Approved
  •   431/15, 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

  •   arm 1 - long-term follow-up of patients treated by flexible ureteroscopy for renal stones
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Characteristics

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

Stone-related events

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Secondary Outcome

mode of retreatment, time of event, late complications

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/01/01
  •   100
  •   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

100 consecutive patients treated with RIRS for renal calculi of any size and location between 2009-2011 in our department of Urology.

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Exclusion Criteria

ureteral stones

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  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 Freiburg Department Chirurgie Klinik für Urologie
    •  
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    •   0761/27025820
    •   0761/27028780
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2016/04/01
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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.