EHP-5 in Preoperative Assessment in Women With Endometriosis

• Conditions: Endometriosis; Endometriosis, Rectum; Endometriosis Ovary; Endometriosis-related Pain; Quality of Life; Endometrioma
• Interventions: Procedure: Surgically treated women with endometriosis and confirmed diagnosis

• Registration Number: NCT04491305
• Lead Sponsor: University of Zagreb

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.

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-25
• Study First Submitted QC: 2020-07-25
• Last Update Submitted: 2020-07-25
• Study First Posted: 2020-07-29
• Last Update Posted: 2020-07-29
• Study Start: 2020-08-01
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with pathohistological confirmation	Surgically treated women with endometriosis and confirmed diagnosis	Women aged between 18 and 50 with surgically proven endometriosis.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Clinical Hospital Centre Zagreb, Croatia; 🇭🇷 Zagreb, Croatia