Trial document




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  DRKS00012601

Trial Description

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Title

Varicose veins treatment in the course of time

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The therapy of varicose veins developed rapidly in the last two decade. Numerous new therapy methods have been added. Surgical treatment has been a gold standard for many years. International guidelines currently recommend endoluminal laser ablation, radiofrequency ablation or sclerotherapy treatment of varicose veins as first line treatment. The extent and establishment of these new techniques in clinical practice in Germany over the last 20 years to date is unknown.
The purpose of this survey is to answer the following questions:
• Which treatment methods have been used 20 years ago, 10 years ago and today to treat the primary varicose veins and recurrent varicose veins?
• What are the different therapies usually used in Germany?
• Can there be differences in the use of the therapy options depending on the age, the specialisation or the place of work of the physician?
In order to clarify these questions, all phlebologists who work in the certificated vein competence centres in German are to be included in the study.
A one-time survey is going to take place. The questionnaire will be sent electronically (via E-mail). The return via E-mail, fax or by post is possible.
The questionnaire data will be entered anonymous in the analyse sheets and the documents (in form of letter, fax or E-mail) will be immediately destroyed. Only the anonymous data of the completed sheets will be entered into the database and will be evaluated.

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Brief Summary in Scientific Language

The therapy of varicose veins developed rapidly in the last two decade. Numerous new therapy methods have been added. Surgical treatment with crossectomy and saphenectomy has been a gold standard for many years. International guidelines (NICE, AVF) currently recommend endoluminal laser ablation, radiofrequency ablation or sclerotherapy treatment of varicose veins as first line treatment.
The extent and establishment of these new techniques in clinical practice in Germany over the last 20 years to date is unknown. Therefore a survey about the therapy methods for primary varicose veins and recurrent varicose veins 20 years ago, 10 years ago and today will take place. All phlebologists, who work in the certificated vein competence centres in German are to be included in the study. (According to the German Society of Phlebology and the Professional Association of Phlebologists 149 centres (Stand 4/2017)).
The questionnaire will be sent electronically, and it can be returned via E-mail, fax or post. All accompanying materials (e.g., envelopes, mail, facsimile sheets) that allow identification of the sender will be destroyed immediately after entering the data in the evaluation sheets. Only the anonymous data of the questionnaires are transferred to the data sheets and evaluated. The evaluation is descriptive and pooled.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00012601
  •   2017/06/26
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  •   yes
  •   Approved
  •   17-6041 , Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

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Health Condition or Problem studied

  •   I83.9 -  Varicose veins of lower extremities without ulcer or inflammation
  •   I83.1 -  Varicose veins of lower extremities with inflammation
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Interventions/Observational Groups

  •   One-time survey of study participants. All vein competence centers will be invited to participate in the study.
    Study participants: phlebologists who work in one of the vein competence centers in Germany. Theme of questioning: therapy of varicosis, therapy methods actually and 10 resp. 20 years ago.
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Characteristics

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

Mainly used method for the therapy of varicose veins and recurrence varicose veins:
The evaluation is carried out by means of descriptive statistics.
For numerical data, mean values ​​and standard deviations or medians and quartiles will be calculated, depending on the distribution.
Categorical data will be presented as absolute and relative.
The evaluation takes place immediately after the data collection. The data evaluation is planned for October / November 2017. The data will be presented in the journal 'Phlebologie'.

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Secondary Outcome

Doctors:
- Age
- Specialisation
- clinic, ambulant, general practice?
- postcode
Data are recorded using a one-time questionnaire.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/06/27
  •   149
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Doctor in a Vein competence center (certificate of the DGP / BVP)

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Exclusion Criteria

no

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Addresses

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    • Phlebologisches Studienzentrum am Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken
    • Hiltroper Landwehr 11-3
    • 44805  Bochum
    • Germany
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    • Gefäßmedizinische Praxis Wernigerode
    • Ms.  Kristina  Korsake 
    • Ilsenburger Str. 46
    • 38855  Wernigerode
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    • Phlebologisches Studienzentrum am Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken
    • Ms.  Prof. Dr. med.  Stefanie  Reich-Schupke 
    • Hiltroper Landwehr 11-3
    • 44805  Bochum
    • Germany
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    • Phlebologisches Studienzentrum am Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken
    • Ms.  Prof. Dr. med.  Stefanie  Reich-Schupke 
    • Hiltroper Landwehr 11-3
    • 44805  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Phlebologisches Studienzentrum am Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken
    • Hiltroper Landwehr 11-3
    • 44805  Bochum
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/10/01
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Trial Publications, Results and other Documents

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