EHP-5 in Preoperative Assessment in Women With Endometriosis

NCT04491305 | Unknown

• 1 other identifier: PetrovaZg
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

endometriosis; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• EHP-5 score in postoperative surveillance

  Postoperative routine surveillance at two different time points - 6 weeks and 6 months after operation

Study Arms (1)

Women with pathohistological confirmation

Women aged between 18 and 50 with surgically proven endometriosis.

Procedure: Surgically treated women with endometriosis and confirmed diagnosis

Interventions

Surgically treated women with endometriosis and confirmed diagnosis PROCEDURE

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

Women with pathohistological confirmation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

Clinical Hospital Centre Zagreb, Croatia

Zagreb, 10 000, Croatia

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Mislav Mikuš, MD

  University Hospital Center Zagreb, Croatia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mislav Mikuš, MD

CONTACT

+385994006639; m.mikus19@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 25, 2020
• First Posted: July 29, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)