EndometriosisNCT04144998
Central Sensitization and Outcome of Endometriosis Surgery
An observational study of Endometriosis, run by Benno Rehberg-Klug at 1 site in Switzerland.
Trial summary
This study will evaluate whether the degree of central sensitization as measured by the questionnaire "central sensitization inventory CSI" is related to the outcome of surgical endometriosis treatment 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?
- central sensitization inventory (questionnaire)
- How many people
- 71 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2019to 13 Jun 2022
- 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: patients scheduled for elective endometriosis surgery
Who may be able to join
- Primary surgery because of pelvic/abdominal pain under suspected diagnosis of and with the aim to confirm endometriosis
- Elective abdominal surgery in women with pelvic/abdominal pain and confirmed endometriosis
Who cannot join
- Patient is unable to give consent
- Cognitive impairment
- Patient outcomes questionnaire is not available in a language that the patient knows.
- Secondary surgery due to complications
- Endometriosis Surgery due to infertility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Substudy on Central Sensitization and Outcome of Endometriosis Surgery of the PROMPT Study
This study will evaluate whether the degree of central sensitization as measured by the questionnaire "central sensitization inventory CSI" is related to the outcome of surgical endometriosis treatment
- Conditions
- Endometriosis
- Being tested
- central sensitization inventory (questionnaire)
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
central sensitization inventory (questionnaire)Diagnostic test
T.G. Mayer, R. Neblett, H. Cohen, et al. The development and psychometric validation of the central sensitization inventory Pain Pract, 12 (2012), pp. 276-285
What is being measured
The primary outcome is the main question the study is designed to answer.
endometriosis health profile EHP-30 pain subscale
Pain subscale of the questionnaire "endometriosis health profile" EHP-30, scale from 0-100, higher values indicate worse health status
Measured: 6 months
Secondary outcomes (1)
other subscales of the endometriosis health profile EHP-30
control and powerlessness scale, emotional well-being scale, social support scale, self-image scale, all scales from 0-100, higher values indicate worse health status
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Oct 2019
- Primary completion31 Dec 2021
- Study completion13 Jun 2022
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.
- 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
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benno Rehberg-Klug
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Benno Rehberg-Klug, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144998
- Sponsor's protocol ID
- EndoPROMPT
- Status last verified
- Jul 2022
- First submitted
- 28 Oct 2019
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substudy on Central Sensitization and Outcome of Endometriosis Surgery of the PROMPT Study
- ClinicalTrials.gov ID
- NCT04144998
- Acronym / sponsor ID
- EndoPROMPT
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Benno Rehberg-KlugUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 30 Oct 2019 (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.
This study will evaluate whether the degree of central sensitization as measured by the questionnaire "central sensitization inventory CSI" is related to the outcome of surgical endometriosis treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled for elective endometriosis surgery
Key inclusion criteria (2 listed)
- Primary surgery because of pelvic/abdominal pain under suspected diagnosis of and with the aim to confirm endometriosis
- Elective abdominal surgery in women with pelvic/abdominal pain and confirmed endometriosis
Key exclusion criteria (5 listed)
- Patient is unable to give consent
- Cognitive impairment
- Patient outcomes questionnaire is not available in a language that the patient knows.
- Secondary surgery due to complications
- Endometriosis Surgery due to infertility
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 |
|---|---|---|
| central sensitization inventory (questionnaire)T.G. Mayer, R. Neblett, H. Cohen, et al. The development and psychometric validation of the central sensitization inventory Pain Pract, 12 (2012), pp. 276-285 | Diagnostic test | – |
Primary outcome
endometriosis health profile EHP-30 pain subscale
Time frame: 6 months
Pain subscale of the questionnaire "endometriosis health profile" EHP-30, scale from 0-100, higher values indicate worse health status
1 secondary outcome
other subscales of the endometriosis health profile EHP-30
Time frame: 6 months
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 21 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Benno Rehberg-Klug 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 5 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 21 Jul 2022. 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 health profile EHP-30 pain subscale (time frame: 6 months). 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 21 Jul 2022.