Trial document




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  DRKS00005622

Trial Description

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Title


Influence of gynaecologic interventions (conisation, myomectomy, hysterectomy etc.) on quality of life and sexuality

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Trial Acronym

SLK

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of this study is to evaluate the influence of gynaecologic interventions on quality of life and sexuality. These parameters are assessed by two standarized questionnaires before and after the procedure. All patients who underwent a gynaecologic interventions (conisation, hysterectomy, myomectomy etc.) between 01/10 and 12/14 and give their informed consent to participate are included in the study.

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Brief Summary in Scientific Language

Aim of this study is the evaluation of the impact of gynaecologic surgical procedures on sexuality and quality of life. Both parameters are assessed by standarized questionnaires pre- and postoperatively

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Organizational Data

  •   DRKS00005622
  •   2014/01/13
  •   [---]*
  •   yes
  •   Approved
  •   180/13, Ethik-Kommission bei der Ärztekammer des Saarlandes
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Secondary IDs

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Health Condition or Problem studied

  •   N87 -  Dysplasia of cervix uteri
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Interventions/Observational Groups

  •   Sexuality and quality of life are assessed using two standarized questionnaires. All patients who undergo a gynaecologic operation at our department and who are willing to participate in the study are contacted pre- and postoperatively
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Characteristics

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

Two completed questionnaires (1 x preoperative and 1 x postoperative) from each patient

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Secondary Outcome

n=100

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2014/02/03
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria


Consent to participate
Completeness of questionnaires

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Exclusion Criteria

Refusal to participate in the study
Incompleteness of questionnaires

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Addresses

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    • Abteilung für Gynäkologie & Geburtshilfe Universitätsklinikum Homburg Saar
    • Mr.  Professer Dr. med.  Erich-Franz  Solomayer  
    • Kirrbergerstraße 100
    • 66421  Homburg
    • Germany
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    • Abteilung für Gynäkologie & Geburtshilfe Universitätsklinikum Homburg Saar
    • Ms.  Dr. med.  Julia  Radsoa 
    • Kirrbergerstraße 100
    • 66421  Homburg
    • Germany
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    • Abteilung für Gynäkologie & Geburtshilfe Universitätsklinikum Homburg Saar
    • Ms.  Dr. med.  Julia  Radsoa 
    • Kirrbergerstraße 100
    • 66421  Homburg
    • Germany
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Sources of Monetary or Material Support

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    • Abteilung für Gynäkologie & Geburtshilfe Universitätsklinikum Homburg Saar
    • Ms.  Dr. med.  Julia  Radsoa 
    • Kirrbergerstraße 100
    • 66421  Homburg
    • Germany
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Status

  •   Recruiting ongoing
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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.