EHP-5 in Preoperative Assessment in Women With Endometriosis

University of Zagreb100 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

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

Interventions

Surgically treated women with endometriosis and confirmed diagnosisPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinical Hospital Centre Zagreb, Croatia

Zagreb, Croatia

Outcomes

Primary Outcomes

EHP-5 score can predict extent of surgical procedure

Bigger overall EHP-5 score will be successful predictor of required surgical intervention

Time frame: Intraoperative time

Secondary Outcomes

EHP-5 score in postoperative surveillance

We assume that EHP-5 score can be used as a postoperative surveillance indicator

Time frame: Postoperative routine surveillance at two different time points - 6 weeks and 6 months after operation

Central Contacts

Mislav Mikuš, MD

CONTACT

+385994006639 m.mikus19@gmail.com

Data from ClinicalTrials.gov

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