EndometriosisEHP-5CRONCT04491305
EHP-5 in Preoperative Assessment in Women With Endometriosis
An observational study of Endometriosis and Endometriosis Ovary, run by University of Zagreb at 1 site in Croatia.
Trial summary
There is no validated tool in quality-of-life assessment of women with endometriosis in Croatia. First aim is to validate Endometriosis Health Profile-5 (EHP-5) before implementing this questionnaire in clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Endometriosis Ovary, Endometriosis-related Pain
- What is being tested?
- Surgically treated women with endometriosis and confirmed diagnosis
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Aug 2020to 1 Aug 2021
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: We will include at least 100 women with surgically proven endometriosis in order to establish EHP-5 in our clinical practice.
Who may be able to join
- aged between 18 and 50 years; symptoms of endometriosis (pelvic pain, dyspareunia, dysmenorrhea) for at least 6 months or previously verified primary sterility; pathohistological confirmation of diagnosis after surgical treatment or indicated diagnostic laparoscopy; fluent and literate in Croatian language; ability to independently understand the questions in the questionnaires
Who cannot join
- pregnant women; cognitive impairment or intellectual disability; neurological disorders (e.g. epilepsy, Parkinson disease, multiple sclerosis, cerebrovascular insult); lack of independent mobility and polytraumatic patients; diagnosed vulvodynia and active vulvovaginitis; ongoing urinary tract infection; any form of prior conservative and/or surgical treatment for endometriosis; lack of informed consent
Trial locations and contacts
1 site in 1 country.
Croatia1 site
Clinical Hospital Centre Zagreb, Croatia
Zagreb, 10 000
Mislav Mikuš, MD, + 385 1 460 4646, m.mikus19@gmail.com
About this study
Official title: Implementation of Endometriosis Health Profile-5 (EHP-5) in Croatian Gynecological Practice for Preoperative Assessment in Women With Endometriosis
There is no validated tool in quality-of-life assessment of women with endometriosis in Croatia. First aim is to validate Endometriosis Health Profile-5 (EHP-5) before implementing this questionnaire in clinical practice. After validation, we will prospectively follow women with endometriosis through whole process - pre- and postoperatively.
Read the detailed description
There is no validated tool in quality-of-life assessment of women with endometriosis in Croatia. First aim is to validate Endometriosis Health Profile-5 (EHP-5) before implementing this questionnaire in clinical practice. After validation, we will prospectively follow women with endometriosis through whole process - pre- and postoperatively, including comparison with rASRM and Enzian score which are already established in our Clinic.
We will try to identify correlation between EHP-5 score and surgical findings and to provide better insight in quality of life consideration of women with endometriosis particularly in Croatia. Since we are tertiary referral centre with almost 250 operative procedures which include ovarian, pelvic and/or extra pelvic endometriosis, we believe that this study will bring new tool not only for preoperative assessment but postoperative surveillance.
- Conditions
- Endometriosis, Endometriosis Ovary, Endometriosis-related Pain, Quality of Life, Endometrioma, Endometriosis, Rectum
- Being tested
- Surgically treated women with endometriosis and confirmed diagnosis
- Keywords
- endometriosis, quality of life
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgically treated women with endometriosis and confirmed diagnosisProcedure or surgery
Women with indication for surgery or diagnostic laparoscopy will be enrolled in study.
| Study group | Role | What they receive |
|---|---|---|
| Women with pathohistological confirmation | Women aged between 18 and 50 with surgically proven endometriosis. Receives: Procedure: Surgically treated women with endometriosis and confirmed diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
EHP-5 score can predict extent of surgical procedure
Bigger overall EHP-5 score will be successful predictor of required surgical intervention
Measured: Intraoperative time
Secondary outcomes (1)
EHP-5 score in postoperative surveillance
We assume that EHP-5 score can be used as a postoperative surveillance indicator
Measured: Postoperative routine surveillance at two different time points - 6 weeks and 6 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mislav Mikuš, University of Zagreb
- Investigators
- Mislav Mikuš, MD, Principal investigator, University Hospital Center Zagreb, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491305
- Sponsor's protocol ID
- PetrovaZg
- Acronym
- EHP-5CRO
- Status last verified
- Jul 2020
- First submitted
- 25 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Endometriosis Health Profile-5 (EHP-5) in Croatian Gynecological Practice for Preoperative Assessment in Women With Endometriosis
- ClinicalTrials.gov ID
- NCT04491305
- Acronym / sponsor ID
- EHP-5CRO / PetrovaZg
- Conditions
- Endometriosis, Endometriosis Ovary, Endometriosis-related Pain, Quality of Life, Endometrioma, Endometriosis, Rectum
- Keywords
- endometriosis, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 29 Jul 2020 (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.
There is no validated tool in quality-of-life assessment of women with endometriosis in Croatia. First aim is to validate Endometriosis Health Profile-5 (EHP-5) before implementing this questionnaire in clinical practice. After validation, we will prospectively follow women with endometriosis through whole process - pre- and postoperatively.
Detailed description
There is no validated tool in quality-of-life assessment of women with endometriosis in Croatia. First aim is to validate Endometriosis Health Profile-5 (EHP-5) before implementing this questionnaire in clinical practice. After validation, we will prospectively follow women with endometriosis through whole process - pre- and postoperatively, including comparison with rASRM and Enzian score which are already established in our Clinic.
We will try to identify correlation between EHP-5 score and surgical findings and to provide better insight in quality of life consideration of women with endometriosis particularly in Croatia. Since we are tertiary referral centre with almost 250 operative procedures which include ovarian, pelvic and/or extra pelvic endometriosis, we believe that this study will bring new tool not only for preoperative assessment but postoperative surveillance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with pathohistological confirmation | – | Procedure: Surgically treated women with endometriosis and confirmed diagnosisWomen aged between 18 and 50 with surgically proven endometriosis. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- We will include at least 100 women with surgically proven endometriosis in order to establish EHP-5 in our clinical practice.
Key inclusion criteria (1 listed)
- aged between 18 and 50 years; symptoms of endometriosis (pelvic pain, dyspareunia, dysmenorrhea) for at least 6 months or previously verified primary sterility; pathohistological confirmation of diagnosis after surgical treatment or indicated diagnostic laparoscopy; fluent and literate in Croatian language; ability to independently understand the questions in the questionnaires
Key exclusion criteria (1 listed)
- pregnant women; cognitive impairment or intellectual disability; neurological disorders (e.g. epilepsy, Parkinson disease, multiple sclerosis, cerebrovascular insult); lack of independent mobility and polytraumatic patients; diagnosed vulvodynia and active vulvovaginitis; ongoing urinary tract infection; any form of prior conservative and/or surgical treatment for endometriosis; lack of informed consent
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 |
|---|---|---|
| Surgically treated women with endometriosis and confirmed diagnosisWomen with indication for surgery or diagnostic laparoscopy will be enrolled in study. | Procedure or surgery | Women with pathohistological confirmation |
Primary outcome
EHP-5 score can predict extent of surgical procedure
Time frame: Intraoperative time
Bigger overall EHP-5 score will be successful predictor of required surgical intervention
1 secondary outcome
EHP-5 score in postoperative surveillance
Time frame: Postoperative routine surveillance at two different time points - 6 weeks and 6 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Mislav Mikuš, MD principal investigator
University Hospital Center Zagreb, Croatia
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 and Endometriosis Ovary, run by University of Zagreb at 1 site in Croatia.
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 1 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: status not confirmed, as of the sponsor's last update on 29 Jul 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 Croatia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mislav Mikuš, MD (+385994006639, m.mikus19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EHP-5 score can predict extent of surgical procedure (time frame: Intraoperative time). 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 29 Jul 2020.