EndometriosisNCT03769584
Follow-up of Treatment Outcome, Quality of Life, Sexual Life and Partnership After Surgery of Endometriosis
An observational study of Endometriosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Follow-up questionnaire and Follow- up interview
- How many people
- 31 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Dec 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women with endometriosis undergoing surgery of endometriosis at Frauenklinik of University Hospital Basel (from 01.01.2017 until 31.12.2017)
Who may be able to join
- 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
Who cannot join
- incapable of consenting
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Endometriosis
- Being tested
- Follow-up questionnaire, Follow- up interview
- Keywords
- quality of life, treatment outcome, sexuality, partnership, surgery of endometriosis
- Medical subject headings
- Endometriosis, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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")
Measured: 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")
Measured: 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
semi- structured interview to assess comments of study participants that are not depicted in the questionnaires
Measured: 1 year after surgery of endometriosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start15 Dec 2018
- Primary completion9 Apr 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sibil Tschudin, PD Dr. med, Principal investigator, Frauenklinik Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769584
- Sponsor's protocol ID
- 2018-01728; sp18Tschudin
- Other IDs
- 2018
- Status last verified
- Jan 2020
- First submitted
- 6 Dec 2018
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Treatment Outcome, Quality of Life, Sexual Life and Partnership After Surgery of Endometriosis
- ClinicalTrials.gov ID
- NCT03769584
- Acronym / sponsor ID
- 2018-01728; sp18Tschudin
- Conditions
- Endometriosis
- Keywords
- quality of life, treatment outcome, sexuality, partnership, surgery of endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 9 Apr 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women with endometriosis undergoing surgery of endometriosis at Frauenklinik of University Hospital Basel (from 01.01.2017 until 31.12.2017)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- incapable of consenting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow-up questionnaireOnline- Questionnaire investigating Follow-up of Treatment Outcome, Quality of Life, Sexual Life and Partnership After Surgery of Endometriosis | Other | – |
| Follow- up interviewSemi- structured Interview investigating Follow-up of Treatment Outcome, Quality of Life, Sexual Life and Partnership After Surgery of Endometriosis | Other | – |
Primary outcome
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
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
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
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
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")
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")
1 secondary outcome
Follow-up of Treatment outcome of surgery of endometriosis assessed by interview
Time frame: 1 year after surgery of endometriosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sibil Tschudin, PD Dr. med principal investigator
Frauenklinik Universitätsspital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometriosis- associated symptoms assessed by questionnaire (time frame: 1 year after surgery of endometriosis). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.