Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT04491305
Status:
UNKNOWN
Last Update Posted:
2020-07-29
First Post:
2020-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EHP-5 in Preoperative Assessment in Women With Endometriosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-25', 'studyFirstSubmitDate': '2020-07-25', 'studyFirstSubmitQcDate': '2020-07-25', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EHP-5 score can predict extent of surgical procedure', 'timeFrame': 'Intraoperative time', 'description': 'Bigger overall EHP-5 score will be successful predictor of required surgical intervention'}], 'secondaryOutcomes': [{'measure': 'EHP-5 score in postoperative surveillance', 'timeFrame': 'Postoperative routine surveillance at two different time points - 6 weeks and 6 months after operation', 'description': 'We assume that EHP-5 score can be used as a postoperative surveillance indicator'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endometriosis', 'quality of life'], 'conditions': ['Endometriosis', 'Endometriosis Ovary', 'Endometriosis-related Pain', 'Quality of Life', 'Endometrioma', 'Endometriosis, Rectum']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nWe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We will include at least 100 women with surgically proven endometriosis in order to establish EHP-5 in our clinical practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT04491305', 'acronym': 'EHP-5CRO', 'briefTitle': 'EHP-5 in Preoperative Assessment in Women With Endometriosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Zagreb'}, 'officialTitle': 'Implementation of Endometriosis Health Profile-5 (EHP-5) in Croatian Gynecological Practice for Preoperative Assessment in Women With Endometriosis', 'orgStudyIdInfo': {'id': 'PetrovaZg'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with pathohistological confirmation', 'description': 'Women aged between 18 and 50 with surgically proven endometriosis.', 'interventionNames': ['Procedure: Surgically treated women with endometriosis and confirmed diagnosis']}], 'interventions': [{'name': 'Surgically treated women with endometriosis and confirmed diagnosis', 'type': 'PROCEDURE', 'description': 'Women with indication for surgery or diagnostic laparoscopy will be enrolled in study.', 'armGroupLabels': ['Women with pathohistological confirmation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10 000', 'city': 'Zagreb', 'country': 'Croatia', 'contacts': [{'name': 'Mislav Mikuš, MD', 'role': 'CONTACT', 'email': 'm.mikus19@gmail.com', 'phone': '+ 385 1 460 4646'}], 'facility': 'Clinical Hospital Centre Zagreb, Croatia', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}], 'centralContacts': [{'name': 'Mislav Mikuš, MD', 'role': 'CONTACT', 'email': 'm.mikus19@gmail.com', 'phone': '+385994006639'}], 'overallOfficials': [{'name': 'Mislav Mikuš, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Center Zagreb, Croatia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zagreb', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Mislav Mikuš', 'investigatorAffiliation': 'University of Zagreb'}}}}