Trial document





This trial has been registered retrospectively.
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  DRKS00014050

Trial Description

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Title

Quality assurance study for vascular surgical patient information

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of the patient information about an operation or treatment is to inform the patient in the best possible way about the chances of success, but also about the risks. At best, the patient will have the same level of information at the end of the information as the attending physician or clinician, and the pros and cons of the operation or treatment may be judged from his personal point of view. The aim of the study is to use questionnaires to improve the effectiveness of the informed consent. Therefore, a few days after the patient information, but before the operation, the patients were asked to complete a short questionnaire regarding the level of satisfaction of the patient information, their personal concerns about the planned procedure, and any remaining ambiguity.
Furthermore, a questionnaire was completed at the end of the inpatient stay to the satisfaction of the overall treatment as well as the inpatient stay itself.

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Brief Summary in Scientific Language

The surgical patient information is important for the direct interaction between the treating physician and the patient.
The hypothesis was that the patient's perception and reminder of the patient information had an impact on the patient's satisfaction with the outcome of the procedure and its subsequent compliance in the elective treatment setting.
This study will be retrospectively registered as the final evaluation of the study has not yet taken place.

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Organizational Data

  •   DRKS00014050
  •   2018/02/19
  •   [---]*
  •   yes
  •   Approved
  •   184/14, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1209-4559 
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Health Condition or Problem studied

  •   I70.21 -  [generalization I70.2: Atherosclerosis of arteries of extremities]
  •   I70.22 -  [generalization I70.2: Atherosclerosis of arteries of extremities]
  •   I70.23 -  [generalization I70.2: Atherosclerosis of arteries of extremities]
  •   I70.24 -  [generalization I70.2: Atherosclerosis of arteries of extremities]
  •   I74.3 -  Embolism and thrombosis of arteries of lower extremities
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Interventions/Observational Groups

  •   1st phase:
    - Informed consent to the study immediately after the surgical information
    - questionnaire 1 to fill in after the discussion, 1 day before the procedure, usually on the day of admission (who, how, which complications, etc.)

    2nd phase:
    - directly postoperatively
    - questionnaire 2 on discharge: Satisfaction OP, medical care, goals in the home environment

    3rd phase:
    - medium-term course
    - Quality of life questionnaire at the first outpatient visit
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Characteristics

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

Examination of the postoperative quality of life as a target variable depending on the actual and the expected (desired by the patient) postoperative course with Quality of life questionnaire at the first outpatient visit

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Secondary Outcome

1. Increasing patient satisfaction and "perceived" safety:
Examination of patient memory selectivity for possible complications, potential surgical success and failure, depending on the actual postoperative 30-day and long-term course, e.g. Overvaluation of the OP's chances, neglecting the risks, postoperative disappointment etc.

2. Investigation of further influencing factors on the evaluation of the benefit-risk relation, e.g. OP (2 different OPs for comparison) of comorbidities, sex and age.

3. Is it possible to arrange the surgical discussion so that the postoperative mean patient satisfaction and quality of life in the case of a complicated postoperative course is better than before?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/12/22
  •   200
  •   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

Patients with elective surgery:
Femoral Fork Thrombendarterectomy (TEA) in arterial obstructive disease (AOD),
- aortic intervention (minimally invasive or open-surgical) in infrarenal abdominal aortic aneurysm,
- Digital Subtraction Angiography (DSA) due to an AOD

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Exclusion Criteria

- non-competent patients (care),
- refusal of participation,
- OP on the day of admission,
- outpatient procedures,
- emergency or urgent surgery

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinik für Allgemein-, Viszeral-und Gefäßchirurgie
    • Mr.  PD Dr. med.  Andrej  Udelnow 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Städtisches Klinikum DessauKlinik für Gefäß- und Endovaskuläre Chirurgie/Phlebologie
    • Mr.  PD Dr. med.  Andrej  Udelnow 
    • Auenweg 38
    • 06847   Dessau
    • Germany
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    • Städtisches Klinikum DessauKlinik für Gefäß- und Endovsakuläre Chirurgie/Phlebologie
    • Mr.  PD Dr. med.  Andrej  Udelnow 
    • Auenweg 38
    • 06847  Dessau
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik für Allgemein-, Viszeral- und Gefäßchirurgie
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/11/24
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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.