- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04491305
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mislav Mikuš, MD
- Phone Number: +385994006639
- Email: m.mikus19@gmail.com
Study Locations
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-
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Zagreb, Croatia, 10 000
- Clinical Hospital Centre Zagreb, Croatia
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Contact:
- Mislav Mikuš, MD
- Phone Number: + 385 1 460 4646
- Email: m.mikus19@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Women with pathohistological confirmation
Women aged between 18 and 50 with surgically proven endometriosis.
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Women with indication for surgery or diagnostic laparoscopy will be enrolled in study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EHP-5 score can predict extent of surgical procedure
Time Frame: Intraoperative time
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Bigger overall EHP-5 score will be successful predictor of required surgical intervention
|
Intraoperative time
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EHP-5 score in postoperative surveillance
Time Frame: Postoperative routine surveillance at two different time points - 6 weeks and 6 months after operation
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We assume that EHP-5 score can be used as a postoperative surveillance indicator
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Postoperative routine surveillance at two different time points - 6 weeks and 6 months after operation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mislav Mikuš, MD, University Hospital Center Zagreb, Croatia
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PetrovaZg
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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