Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT04791033
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2021-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality of Life After Hysterectomy (AdenoQOL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D062788', 'term': 'Adenomyosis'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007044', 'term': 'Hysterectomy'}], 'ancestors': [{'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 218}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2021-03-05', 'studyFirstSubmitQcDate': '2021-03-05', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The impact of hysterectomy on health related quality of life assessed by SF-36 sub scale bodily pain', 'timeFrame': '1 year', 'description': 'The Short Form Health Survey (SF-36) measures eight sub scales including bodily pain (BP) which in this study is used as primary outcome. The scales ranges from 0-100, a higher score indicates a better quality of life.'}], 'secondaryOutcomes': [{'measure': 'The impact of hysterectomy on health related quality of life assessed by SF-36 sub scales', 'timeFrame': '5 years', 'description': 'The Short Form Health Survey (SF-36) measures eight subscales. In this study seven sub scales is used as secondary outcomes: Physical functioning (PF), role physical (RP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE) and mental health (MH). The scales ranges from 0-100, a higher score indicates a better quality of life.'}, {'measure': 'The impact of hysterectomy on health related quality of life assessed by SF-36 eight subscales', 'timeFrame': '5 years', 'description': 'The Short Form Health Survey (SF-36) measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The scales ranges from 0-100, a higher score indicates a better quality of life.'}, {'measure': 'The impact of hysterectomy on sexual function assessed by FSFI', 'timeFrame': '1 year', 'description': 'The Female Sexual Function Index (FSFI) use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual functioning. To score the measure the sum of each domain score (sexual desire, arousal, lubrication, orgasm, satisfaction and pain) is multiplied by a domain factor and summed to derive a total FSFI score.'}, {'measure': 'The impact of hysterectomy on sexual function assessed by FSFI', 'timeFrame': '5 years', 'description': 'The Female Sexual Function Index (FSFI) use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual functioning. To score the measure the sum of each domain score (sexual desire, arousal, lubrication, orgasm, satisfaction and pain) is multiplied by a domain factor and summed to derive a total FSFI score.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hysterectomy', 'Sexual Health', 'Adenomyosis'], 'conditions': ['Adenomyosis', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'Adenomyosis is a disease where ectopic endometrial-like glands affect the muscular wall of the uterus. About 70% of women affected by adenomyosis suffer from dysmenorrhea and menorrhagia. A levonorgestrel-releasing intrauterine device (LNG-IUD) is the first-choice treatment of adenomyosis, but is not always sufficiently effective in all women. Those women often end up removing the uterus (hysterectomy).\n\nHysterectomy is clinically regarded to be an efficient and final treatment of adenomyosis, but pelvic pain may also prevail after removal of the uterus. This study aimes to investigate the short - and long-term impact of hysterectomy on quality of life (QOL) and sexual function in women with adenomyosis, and further to evaluate if there is any difference compared to women that are removing their uterus due to other benign gynecological conditions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '52 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A consecutive sample of women that are scheduled for hysterectomy at the study site, who fulfill eligibility criteria, are invited to participate', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premenopausal status defined by having had menstruation within the last 12 months, or age \\< 50 years if amenorrhea due to hormonal treatment\n* Hysterectomy planned due to a benign condition\n* Able to communicate in Norwegian or English\n* Electronic consent given\n\nExclusion Criteria:\n\n* Age \\< 18 years, postmenopausal status or no menstrual bleeding for the last 12 months\n* Hysterectomy as part of female-to-male transition\n* Pelvic organ prolapse as an indication for hysterectomy\n* Gynecological cancer suspected at the time of inclusion\n* Not able to communicate in Norwegian or English'}, 'identificationModule': {'nctId': 'NCT04791033', 'briefTitle': 'Quality of Life After Hysterectomy (AdenoQOL)', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Quality of Life After Hysterectomy for Adenomyosis and Other Benign Gynecological Conditions', 'orgStudyIdInfo': {'id': '213906'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adenomyosis', 'description': 'Patients with adenomyosis', 'interventionNames': ['Procedure: Hysterectomy']}, {'label': 'Other benign gynecological conditions', 'description': 'Patients with other benign gynecological conditions (i.e: myomas, endometriosis).', 'interventionNames': ['Procedure: Hysterectomy']}], 'interventions': [{'name': 'Hysterectomy', 'type': 'PROCEDURE', 'description': 'Elective procedure with hysterectomy due to benign gynecological condition', 'armGroupLabels': ['Adenomyosis', 'Other benign gynecological conditions']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': 'Marianne Omtvedt', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Marianne Omtvedt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}, {'name': 'Tina Tellum, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oslo University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'The data is planned to be made available within a year after the publication of all results.', 'ipdSharing': 'YES', 'description': 'We will share the values of the quality of life data.', 'accessCriteria': 'Access will be granted upon request and evaluation of the intended use of the data. The intended use should primarily gain improved patient care and research into quality of life after hysterectomy and a detailed protocol has to be submitted.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marianne Omtvedt', 'investigatorAffiliation': 'Oslo University Hospital'}}}}