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

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Mislav Mikuš, MD; Phone Number: +385994006639; Email: m.mikus19@gmail.com

Study Locations

• Croatia
  • Zagreb, Croatia, 10 000
    • Clinical Hospital Centre Zagreb, Croatia
    • Contact: Mislav Mikuš, MD; Phone Number: + 385 1 460 4646; Email: m.mikus19@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

We will include at least 100 women with surgically proven endometriosis in order to establish EHP-5 in our clinical practice.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women with pathohistological confirmation; Women aged between 18 and 50 with surgically proven endometriosis.	Procedure: Surgically treated women with endometriosis and confirmed diagnosis; Women with indication for surgery or diagnostic laparoscopy will be enrolled in study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Zagreb
• Investigators: Principal Investigator: Mislav Mikuš, MD, University Hospital Center Zagreb, Croatia

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: July 25, 2020
• First Submitted That Met QC Criteria: July 25, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 25, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; endometriosis
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: PetrovaZg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No