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

January 29, 2020 updated by: University Hospital, Basel, Switzerland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Frauenklinik University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year after surgery of endometriosis
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
1 year after surgery of endometriosis
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
before surgery of endometriosis and 1 year after surgery of endometriosis
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
before surgery of endometriosis and 1 year after surgery of endometriosis
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")
before surgery of endometriosis and 1 year after surgery of endometriosis
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")
before surgery of endometriosis and 1 year after surgery of endometriosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year after surgery of endometriosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 15, 2018

Primary Completion (ACTUAL)

April 9, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

December 6, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (ACTUAL)

December 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-01728; sp18Tschudin

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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