EHP-5 in Preoperative Assessment in Women With Endometriosis

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Procedure: Surgically treated women with endometriosis and confirmed diagnosis


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with pathohistological confirmation<br>Women aged between 18 and 50 with surgically proven endometriosis. | Procedure: Surgically treated women with endometriosis and confirmed diagnosis<br>* Women with indication for surgery or diagnostic laparoscopy will be enrolled in study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EHP-5 score can predict extent of surgical procedure | Bigger overall EHP-5 score will be successful predictor of required surgical intervention | Intraoperative time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EHP-5 score in postoperative surveillance | We assume that EHP-5 score can be used as a postoperative surveillance indicator | Postoperative routine surveillance at two different time points - 6 weeks and 6 months after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometriosis, quality of life