EHP-5 in Preoperative Assessment in Women With Endometriosis

NCT ID: NCT04491305

Last Updated: 2020-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-08-01

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with pathohistological confirmation

Women aged between 18 and 50 with surgically proven endometriosis.

Surgically treated women with endometriosis and confirmed diagnosis

Intervention Type PROCEDURE

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

Interventions

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Surgically treated women with endometriosis and confirmed diagnosis

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Zagreb

OTHER

Sponsor Role lead

Responsible Party

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Mislav Mikuš

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mislav Mikuš, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Center Zagreb, Croatia

Locations

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Clinical Hospital Centre Zagreb, Croatia

Zagreb, , Croatia

Site Status

Countries

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Croatia

Central Contacts

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Mislav Mikuš, MD

Role: CONTACT

+385994006639

Facility Contacts

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Mislav Mikuš, MD

Role: primary

+ 385 1 460 4646

Other Identifiers

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PetrovaZg

Identifier Type: -

Identifier Source: org_study_id

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