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EHP-5 in Preoperative Assessment in Women With Endometriosis (EHP-5CRO)

U

University of Zagreb

Status

Unknown

Conditions

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

Treatments

Procedure: Surgically treated women with endometriosis and confirmed diagnosis

Study type

Observational

Funder types

Other

Identifiers

NCT04491305
PetrovaZg

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Women with pathohistological confirmation
Description:
Women aged between 18 and 50 with surgically proven endometriosis.
Treatment:
Procedure: Surgically treated women with endometriosis and confirmed diagnosis

Trial contacts and locations

1

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Central trial contact

Mislav Mikuš, MD

Data sourced from clinicaltrials.gov

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