Trial document





This trial has been registered retrospectively.
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  DRKS00014995

Trial Description

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Title

Evaluation of the knowledge about the implementation of the currently valid guidelines for the diagnosis and treatment of endometriosis by gynecologists in Germany

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In order to assess the state of knowledge of established gynecologists on the current guideline for the diagnosis and treatment of endometriosis, we designed a questionnaire. The physicians from Lower Saxony, Thuringia and North Rhine-Westphalia are interviewed. The questionnaire has been adapted to show exactly whether the gynecologists know and can apply the latest diagnostic and therapeutic measures. We decided to create a "single-choice questionnaire" containing exactly one correct answer that needs to be ticked.
The deep infiltrating endometriosis and the sterility that can be caused by this disease are in the foreground, as well as the physical and mental suffering of the patients.
The basic idea behind the question was the finding that endometriosis is often recognized on an outpatient basis with a latency of up to 10 years.

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Brief Summary in Scientific Language

Endometriosis is a disease whose etiology and pathogenesis are not fully understood. In this case, endometrium-like cell aggregates occur outside of the uterine cavity. Guiding symptoms are u.a. premenstrual pain, dysmenorrhoea, bowel problems and sometimes also sterility. Endometriosis is a frequently occurring gynecological disease of reproductive age with an estimated prevalence of 40,000 new cases per year in Germany. Endometriosis causes high morbidity and extreme suffering. This, in particular, is compounded by the fact that the disease is recognized and treated with a delay of up to 10 years.
The consequences, in particular of a deeply infiltrating endometriosis, are sometimes severe, since the pathological-histological benign disease can grow organ-independently and can lead to multiple surgical procedures. Furthermore, a malignancy, usually an ovarian carcinoma, may develop in rare cases at the bottom of endometriosis. For the course of the disease, it is therefore expedient to initiate as soon as possible the correct diagnosis and optimal therapy with regard to the various manifestations of endometriosis internital and externa or extragenitalis, as well as the deeply infiltrating endometriosis. The knowledge of the current evidence-based guideline for the diagnosis and treatment of endometriosis of the German Society for Gynecology and Obstetrics (DGGG) should serve the treating physicians as a basis for the care of their patients, but until now there is only a little information about their knowledge.
Four years after the updated guideline was published, the aim of this study is to evaluate the current state of knowledge of general practitioners. Furthermore, the question should specifically aim to investigate whether the differences in diagnosis and therapy of the different locations and stages, which are described in detail in the guideline, are known. Furthermore, the current 3rd edition contains new findings on unwanted childlessness and deep infiltrating endometriosis.
question
How well are gynecology and obstetrics physicians familiar with the current guideline from 2013 on the diagnosis and treatment of endometriosis, and how well done is their implementation?

methodology

In order to investigate the above question, we will use a questionnaire study, in the style of a single choice test. This should include questions about the physicians' personalities (gender, age and area of ​​activity), their self-assessment and the current state of diagnostics and treatment options with regard to the various forms of endometriosis. This is followed by general questions on the evidence-based guidelines of the DGGG and AGE, the working group for gynecological and obstetric endoscopy. The AGE acts as a specialist society of the DGGG and supports endoscopically-active colleagues by, inter alia. Offer training and certification.
The anonymised questionnaires are sent to all general practitioners for gynecology and obstetrics in Lower Saxony, Thuringia and North Rhine-Westphalia.
First of all, we would like to check whether the questionnaire is easy to handle in terms of handling and comprehensibility and will therefore give it to the colleagues of the clinic for answering.
The evaluation is carried out by means of descriptive statistics.
Expected new findings
We hope to use this study to evaluate the current state of knowledge for the diagnosis and treatment of the different manifestations of endometriosis of the treating physicians and, if necessary, to uncover optimization possibilities. From the results, more advanced and better-adapted training could be offered to fill in any gaps in knowledge that would otherwise lead to delayed diagnosis or not optimally adapted therapy.

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Organizational Data

  •   DRKS00014995
  •   2018/07/27
  •   [---]*
  •   yes
  •   Approved
  •   Nr. 7714_BO_K_2018, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

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Health Condition or Problem studied

  •   N80 -  Endometriosis
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Interventions/Observational Groups

  •   Questionnaire-based survey of practicing gynecologists and gynecologists regarding the current state of the guideline for the diagnosis and treatment of endometriosis
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Characteristics

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

Level of knowledge concerning the current guideline of diagnostics and therapy of endometriosis of registered gynecologists in Lower Saxony, Thuringia and North Rhine-Westphalia on the basis of a single-choice-test.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2018/01/12
  •   2000
  •   Multicenter 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

Registered doctors

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Exclusion Criteria

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Medizinische Hochschule Hannover
    • Ms.  PD Dr.  Cordula  Schippert 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Ms.  PD Dr.  Cordula  Schippert 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Ms.  PD Dr.  Cordula  Schippert 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Hochschule Hannover
    • Ms.  PD Dr.  Cordula  Schippert 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Ethikvotum
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* This entry means the parameter is not applicable or has not been set.