Trial document




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  DRKS00007478

Trial Description

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Title

Ultra-mini PCNL versus flexible ureterorenoscopy: Evaluation of outcome, perioperative complications and analgetic consumption for the treatment of patients with kidney stones

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Treatment of kidney Stones is possible with ureteroscopy and with percutaneous approaches (for example Ultra-Mini-PCNL = percutaneous nephrolitholapaxy). First studies Show equal results for outcome and complication rates. Here we compare patients who underwent one of the treatments. Besides outcome and complication rates perioperative analgetic consumption and patient satisfaction will be assessed.

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Brief Summary in Scientific Language

The recently introduced miniaturized Version of nephrolitholapaxie (Ultra-Mini-PCNL) may be an alternative to retrograde intrarenal surgery for the treatment of medium sized kidney stones. First publications showed equal similar stone free rates and complications for the two treatment modalities. For the choice of one of the options additional parameters are to be investigated. With this retrospective matched-pair analysis we study outcome (stone free rate), complication rates, perioperative analgetic consumption and subjective patient satisfaction.

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Organizational Data

  •   DRKS00007478
  •   2014/11/12
  •   [---]*
  •   yes
  •   Approved
  •   504/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1164-0194 
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Health Condition or Problem studied

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

  •   Chart Review of patients who underwent Ultra-Mini-PCNL for the treatment of nephrolithiasis. Assessed parameters are perioperative complications, analgesic consumption, outcome and patient satisfaction.
  •   Patients who underwent flexible ureterorenoscopy for the treatment of nephrolithiasis are matched to the patients from arm 1. The same Parameters are assessed.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Stone free rate: absence of clinical significant residual fragments > 4mm assessed by ultrasound or low-dose CT

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Secondary Outcome

Complications (modified Clavien score),
Perioperative analgetic consumption (assessed with "Cumultaive analgesic consumption score"),
Patient satisfaction (assessed with the "Freiburg Index of Patient Satisfaction" = FIPS)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/11/17
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

Treatment for Nephrolithiasis with either Ultra-Mini-PCNL or retrograde intrarenal surgery

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Exclusion Criteria

Patients without treatment of nephrolithiasis

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Addresses

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    • Universitätsklinikum FreiburgDepartment für ChirurgieKlinik für Urologie
    • Mr.  Dr.  Konrad  Wilhelm 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • 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
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Sources of Monetary or Material Support

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    • Universitätsklinikum FreiburgDepartment für ChirurgieKlinik für Urologie
    • 79106  Freiburg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/02/04
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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.