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EHP-5 in Preoperative Assessment in Women With Endometriosis

Implementation of Endometriosis Health Profile-5 (EHP-5) in Croatian Gynecological Practice for Preoperative Assessment in Women With Endometriosis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04491305
Acronym
EHP-5CRO
Enrollment
100
Registered
2020-07-29
Start date
2020-08-01
Completion date
2021-08-01
Last updated
2020-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrioma, Endometriosis, Endometriosis Ovary, Endometriosis, Rectum, Endometriosis-related Pain, Quality of Life

Keywords

endometriosis, quality of life

Brief 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. 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.

Interventions

PROCEDURESurgically treated women with endometriosis and confirmed diagnosis

Women with indication for surgery or diagnostic laparoscopy will be enrolled in study.

Sponsors

University of Zagreb
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
EHP-5 score can predict extent of surgical procedureIntraoperative timeBigger overall EHP-5 score will be successful predictor of required surgical intervention

Secondary

MeasureTime frameDescription
EHP-5 score in postoperative surveillancePostoperative routine surveillance at two different time points - 6 weeks and 6 months after operationWe assume that EHP-5 score can be used as a postoperative surveillance indicator

Countries

Croatia

Contacts

Primary ContactMislav Mikuš, MD
m.mikus19@gmail.com+385994006639

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026