NCT03769584

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

December 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

December 6, 2018

Last Update Submit

January 29, 2020

Conditions

Endometriosis

Keywords

quality of lifetreatment outcomesexualitypartnershipsurgery of endometriosis

Outcome Measures

Primary Outcomes (6)

  • Endometriosis- associated symptoms assessed by questionnaire

    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

    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

    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

    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

    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

    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 Outcomes (1)

  • Follow-up of Treatment outcome of surgery of endometriosis assessed by interview

    1 year after surgery of endometriosis

Interventions

Follow-up questionnaireOTHER

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

Follow- up interviewOTHER

Semi- structured Interview investigating Follow-up of Treatment Outcome, Quality of Life, Sexual Life and Partnership After Surgery of Endometriosis

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

women with endometriosis undergoing surgery of endometriosis at Frauenklinik of University Hospital Basel (from 01.01.2017 until 31.12.2017)

You may qualify if:

  • 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

You may not qualify if:

  • incapable of consenting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frauenklinik University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

EndometriosisSexuality

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesSexual BehaviorBehavior

Study Officials

  • Sibil Tschudin, PD Dr. med

    Frauenklinik Universitätsspital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2018

First Posted

December 7, 2018

Study Start

December 15, 2018

Primary Completion

April 9, 2019

Study Completion

December 31, 2019

Last Updated

January 30, 2020

Record last verified: 2020-01

Locations

CH(1)