Trial document




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  DRKS00007707

Trial Description

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Title

Stone free rate: Endoscopic vs. low-dos CT control after flexible URS for nephrolithiasis > 10 mm

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

One important parameter for the assessment of success after endoscopic treatment of nephrolithiasis is the stone free rate (SFR). To date it is unclear whether the endoscopic control reveals all stone fragments in the renal pelvis and the calices. However, small fragments increase the risk of recurrence of bigger stones. Gold standard for stone diagnostic is low dose CT scan. However this exposes the patient to radiation. With this study we will examine whether the final endoscopic visual control of the renal pelvis reveals all fragments or misses some of them. If all fragments were found endoscopically the control CT would be unnecessary.

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Brief Summary in Scientific Language

It is till unclear whether the endoscopic control of the stone free rate after endourological treatment of kidney Stones misses residual fragments. No data about a direct correlation with postoperative low-dose CT has been published. This project examines whether the final endoscopic control is necessary and whether a postoperative CT control might be abolished even in studies.


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Organizational Data

  •   DRKS00007707
  •   2015/01/15
  •   [---]*
  •   yes
  •   Approved
  •   581/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1166-1395 
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Health Condition or Problem studied

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

  •   Patients who have been declared as stone free endoscopically after ureterorenoscopy and had additional CT control for the assessment of stone free rate
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Characteristics

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

Stone free rate in the CT control

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Secondary Outcome

Rate of missed residual fragments with endoscopic control

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/02/15
  •   25
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Patients who had ureterorenoscopic stone extraction of kidney Stones > 10 mm and who have been declared as Stone free after the final endoscopic control. Additional they Need to have a control CT

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Exclusion Criteria

Patients that don't fulfill the inclusion criteria

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universtitätsklinikum FreiburgDepartment ChirurgieKlinik für Urologie
    • Mr.  Dr.  Konrad  Wilhelm 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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    • Universtitätsklinikum FreiburgDepartment ChirurgieKlinik für Urologie
    • Mr.  Dr.  Konrad  Wilhelm 
    • Hugstetterstr. 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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    • Universtitätsklinikum FreiburgDepartment ChirurgieKlinik für Urologie
    • Mr.  Dr.  Konrad  Wilhelm 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universtitätsklinikum FreiburgDepartment ChirurgieKlinik für Urologie
    • Mr.  Dr.  Konrad  Wilhelm 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/12/20
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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.