EHP-5 in Preoperative Assessment in Women With Endometriosis

Quality of Life Clinical Trial

— EHP-5CRO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04491305
• Other study ID #: PetrovaZg
• Status: Not yet recruiting
• Start date: August 1, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: July 2020
• Source: University of Zagreb
• Contact: Mislav Mikuš, MD
• Phone: +385994006639
• Email: m.mikus19[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Surgically treated women with endometriosis and confirmed diagnosis
Women with indication for surgery or diagnostic laparoscopy will be enrolled in study.

Locations

Country	Name	City	State
Croatia	Clinical Hospital Centre Zagreb, Croatia	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University of Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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