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Follow-up of Treatment Outcome, Quality of Life, Sexual Life and Partnership After Surgery of Endometriosis

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ClinicalTrials.gov Identifier: NCT03769584
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
Follow-up of treatment outcome, quality of life, sexual life and partnership after surgery of endometriosis by means of a questionnaire 1 year after surgical Intervention.

Condition or disease Intervention/treatment
Endometriosis Other: Follow-up questionnaire Other: Follow- up interview

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Follow-up of Treatment Outcome, Quality of Life, Sexual Life and Partnership After Surgery of Endometriosis
Actual Study Start Date : December 15, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis


Intervention Details:
  • Other: Follow-up questionnaire
    Online- Questionnaire investigating Follow-up of Treatment Outcome, Quality of Life, Sexual Life and Partnership After Surgery of Endometriosis
  • Other: Follow- up interview
    Semi- structured Interview investigating Follow-up of Treatment Outcome, Quality of Life, Sexual Life and Partnership After Surgery of Endometriosis


Primary Outcome Measures :
  1. Endometriosis- associated symptoms assessed by questionnaire [ Time Frame: 1 year after surgery of endometriosis ]
    questionnaire asking for pain (with menstruation, with sexual intercourse, with defecation, with urination) on a Visual Analogue Scale (VAS), ranging from 0 = no pain to 10 = intolerable pain

  2. Treatment outcome of surgery of endometriosis assessed by VAS questionnaire [ Time Frame: 1 year after surgery of endometriosis ]
    questionnaire asking for satisfaction with treatment outcome on a Visual Analogue Scale (VAS), ranging from 0 = absolutely dissatisfied to 10 = absolutely satisfied

  3. Change in Quality of life assessed by questionnaire [ Time Frame: before surgery of endometriosis and 1 year after surgery of endometriosis ]
    questionnaire asking for Quality of life on a Visual Analogue Scale (VAS), ranging from 0 = very bad to 10 = very good

  4. Change in sexual life assessed by questionnaire [ Time Frame: before surgery of endometriosis and 1 year after surgery of endometriosis ]
    questionnaire asking for Sexual life on a Visual Analogue Scale (VAS), ranging from 0 = absolutely dissatisfied to 10 = absolutely satisfied

  5. Change in conduct of life assessed by questionnaire [ Time Frame: before surgery of endometriosis and 1 year after surgery of endometriosis ]
    questionnaire asking for change in conduct of life (partnership, family, professional life, leisure activity, sportive activities) on a 6- item scale (ranging from "negative" to "positive")

  6. Change in wish for child assessed by questionnaire [ Time Frame: before surgery of endometriosis and 1 year after surgery of endometriosis ]
    questionnaire asking for change in wish for child on a 3- item scale (ranging from "yes" , "no answer" to "no")


Secondary Outcome Measures :
  1. Follow-up of Treatment outcome of surgery of endometriosis assessed by interview [ Time Frame: 1 year after surgery of endometriosis ]
    semi- structured interview to assess comments of study participants that are not depicted in the questionnaires



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
women with endometriosis undergoing surgery of endometriosis at Frauenklinik of University Hospital Basel (from 01.01.2017 until 31.12.2017)
Criteria

Inclusion Criteria:

  • surgery of endometriosis at Frauenklinik of University Hospital Basel (from 01.01.2017 until 31.12.2017)
  • sufficient German language skills in order to be able to complete questionnaires

Exclusion Criteria:

  • incapable of consenting

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769584


Contacts
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Contact: Sibil Tschudin, PD Dr. med +41 61 265 90 43 sibil.tschudin@usb.ch

Locations
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Switzerland
Frauenklinik University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Sibil Tschudin, PD Dr. med    +41 61 265 90 43    sibil.tschudin@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Sibil Tschudin, PD Dr. med Frauenklinik Universitätsspital Basel

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03769584     History of Changes
Other Study ID Numbers: 2018-01728; sp18Tschudin
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Basel, Switzerland:
quality of life
treatment outcome
sexuality
partnership
surgery of endometriosis

Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female