Clinical trial NCT04491305: EHP-5 in Preoperative Assessment in Women With Endometriosis
Official title: Implementation of Endometriosis Health Profile-5 (EHP-5) in Croatian Gynecological Practice for Preoperative Assessment in Women With Endometriosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis
Endometriosis Ovary
Endometriosis-related Pain
Quality of Life
Endometrioma
Endometriosis, Rectum
Keywords: endometriosis
quality of life
Lead sponsor: University of Zagreb
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We will include at least 100 women with surgically proven endometriosis in order to establish EHP-5 in our clinical practice.

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.

Eligibility criteria: 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

Primary outcomes:
measure: EHP-5 score can predict extent of surgical procedure
timeFrame: Intraoperative time
Secondary outcomes:
measure: EHP-5 score in postoperative surveillance
timeFrame: Postoperative routine surveillance at two different time points - 6 weeks and 6 months after operation
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb, Croatia
Study officials:
affiliation: University Hospital Center Zagreb, Croatia
name: Mislav Mikuš, MD
role: PRINCIPAL_INVESTIGATOR
References: