EHP-5CRO: EHP-5 in Preoperative Assessment in Women With Endometriosis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Women with pathohistological confirmation Women aged between 18 and 50 with surgically proven endometriosis. |
Procedure: Surgically treated women with endometriosis and confirmed diagnosis
Women with indication for surgery or diagnostic laparoscopy will be enrolled in study.
|
Outcome Measures
Primary Outcome Measures
- EHP-5 score can predict extent of surgical procedure [Intraoperative time]
Bigger overall EHP-5 score will be successful predictor of required surgical intervention
Secondary Outcome Measures
- EHP-5 score in postoperative surveillance [Postoperative routine surveillance at two different time points - 6 weeks and 6 months after operation]
We assume that EHP-5 score can be used as a postoperative surveillance indicator
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Hospital Centre Zagreb, Croatia | Zagreb | Croatia | 10 000 |
Sponsors and Collaborators
- University of Zagreb
Investigators
- Principal Investigator: Mislav Mikuš, MD, University Hospital Center Zagreb, Croatia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PetrovaZg