Trial document




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  DRKS00007668

Trial Description

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Title

Evaluation of ureterorenoscopic stone therapy - results with regard to complications, quality of life and stone-free rate

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Trial Acronym

BUSTER

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of the study is to identify independent factors influencing complications and quality of life as well as stone-free rate after ureterorenoscopic stone therapy, that is to draw a picture of the reality of care.
For this purpose, data from 14 hospitals in Brandenburg, Berlin, Saxony-Anhalt and Bavaria continued to be recorded and evaluated.
Carl-Thiem-Klinikum Cottbus
Havellandklinik Nauen
Klinikum Frankfurt (Oder) GmbH
Klinikum Niederlausitz GmbH / Klinikbereich Lauchhammer
Klinikum St. Elisabeth Straubing GmbH
MediClin Müritz-Klinikum Waren
Ruppiner Kliniken GmbH Neuruppin
Städtisches Klinikum Brandenburg
Universität Regensburg am Caritas-Krankenhaus St. Josef
Universitätsklinikum Magdeburg
Vivantes Humboldt-Klinikum Berlin Reinickendorf
Zeisigwaldkliniken Bethanien Chemnitz
HELIOS Klinikum Bad Saarow/Fürstenwalde
Universitätsklinikum Freiburg

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Brief Summary in Scientific Language

The aim of the now planned multicenter cross-sectional study is without establishing a defined relationship between PULS-degree and indications for urinary diversion (stenting) to identify independent factors influencing complications and quality of life as well as stone-free rate after uretererenoscopic stone therapy, that is to draw a picture of the reality of care. In the absence of a uniform definition of the term "stone-free" the main focus of the planned study is directed on complications and quality of life after ureterorenoscopic stone therapy. For this the following validated instruments are used: • PULSE • Classification of surgical complications after Clavien-Dindo - during hospitalization and after 30 days • Measurement of health-related quality of life 30 days postoperatively by Health Survey short form SF-8 and the Quality of Life questionnaire of the IPSS.
Study hypotheses:
1. The "prestented" URS is associated in comparison to the primary URS with lower PULS scores.
2. Routine placement of a ureteral stent after uncomplicated URS (PULS 0) does not significantly decrease the rate of complications and also deteriorates the LQ in the 30-day course.
3. Increasing surgeons experience is correlated with a lower complication rate and a higher postoperative quality of life.
a. The number of Specialist years of the surgeon is correlated with a lower complication rate and a higher postoperative quality of life. b. A higher self-assessment of the surgeon as to its URS experience correlated with a lower complication rate and a higher postoperative quality of life.
4. The in previous publications demonstrated high inter-rater reliability of the PULS-scores between doctors can be confirmed in the comparison to nursing staff.
5. There is no relationship between annual caseload of the clinic and complication rate, stone-free rate and postoperative quality of life.

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Organizational Data

  •   DRKS00007668
  •   2015/01/09
  •   [---]*
  •   yes
  •   Approved
  •   AS 136(bB)/2014, Ethik-Kommission der Landesärztekammer Brandenburg
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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

  •   In patients with uretererenoscopic stone therapy complications, quality of life and stone-free rate are checked perioperatively and in the 30-day course
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Characteristics

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

Quality of life and complications after ureterorenoscopic stone therapy (URS).
Assessing Quality of Life with the Health Survey SF-8-Questionnaire and IPSS 30 days postoperatively. Detection of complications after Clavien-Dindo (grade 0-5) perioperatively and 30 days postoperatively.

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Secondary Outcome

Reintervention after URS

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2015/01/12
  •   263
  •   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

Consent-capable patient who undergoes a ureterorenoscopic stone therapy

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Exclusion Criteria

Incapacitated patients

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Ruppiner Kliniken GmbH / Medizinische Hochschule Theodor Fontane
    • Mr.  Dr. med.  Steffen  Lebentrau 
    • Fehrbelliner Straße 38
    • 16816  Neuruppin
    • Germany
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    • Ruppiner Kliniken GmbH / Medizinische Hochschule Theodor Fontane
    • Mr.  Dr. med.  Steffen  Lebentrau 
    • Fehrbelliner Straße 38
    • 16816  Neuruppin
    • Germany
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    • Ruppiner Kliniken GmbH / Medizinische Hochschule Theodor Fontane
    • Mr.  Dr. med.  Steffen  Lebentrau 
    • Fehrbelliner Straße 38
    • 16816  Neuruppin
    • Germany
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Sources of Monetary or Material Support

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    • Ruppiner Kliniken GmbH / Medizinische Hochschule Theodor Fontane
    • Mr.  Dr. med.  Steffen  Lebentrau 
    • Fehrbelliner Straße 38
    • 16816  Neuruppin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/09/13
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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.