Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-29 @ 1:45 PM
Study NCT ID:
NCT00876057
Status:
COMPLETED
Last Update Posted:
2012-06-11
First Post:
2009-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychological Well-being, Recovery and Sexuality After Total and Subtotal Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-08', 'studyFirstSubmitDate': '2009-04-03', 'studyFirstSubmitQcDate': '2009-04-03', 'lastUpdatePostDateStruct': {'date': '2012-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychological well-being', 'timeFrame': 'One year after surgery'}], 'secondaryOutcomes': [{'measure': 'Recovery of general well-being', 'timeFrame': 'Five weeks after surgery'}, {'measure': 'Sexuality', 'timeFrame': 'One year'}, {'measure': 'Pelvic organ prolapse (anatomical)', 'timeFrame': '7-14 years', 'description': 'Follow-up median eleven years after the initial hysterectomy. Clinical investigation including POP-Q.'}, {'measure': 'Patient reported symptoms of pelvic organ dysfunction', 'timeFrame': '7-14 years', 'description': 'Follow-up median eleven years after the initial hysterectomy. Questionnaire (Pelvic Floor Dysfuntion Inventoy).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['psychological well-being', 'recovery', 'time in hospital', 'sick-leave', 'complications', 'Sexual well-being'], 'conditions': ['Hysterectomy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether psychological well-being, recovery and sexuality differs in women undergoing subtotal and total abdominal hysterectomy.\n\nSe also Detailed Description for additional study.', 'detailedDescription': 'An additional study study based on the material in original study started in april 2011. The purpose of this study is to investigate the development of pelvis organ prolapse in the long term (median eleven years after hysterectomy and by questionnaires, Pelvic-floor Distress Inventory SF-20 analyze if patient reported symptoms regarding urinary-and bowels functions differs regarding the method of hysterectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primarily uterine fibroids with bleeding disturbance or mechanical symptoms but other benign disorders were hysterectomy was recommended were also eligible\n* After surgery at least one ovary preserved.\n* Informed verbal and written consent\n* Proficiency in Swedish\n\nExclusion Criteria:\n\n* Malignancy in the genital organs.\n* Previous or present cervical dysplasia.\n* Rapidly growing fibroids where malignancy could not be ruled out\n* Preoperative treatment with GnRH analogues.\n* Postmenopausal women without hormone therapy\n* Severe psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT00876057', 'briefTitle': 'Psychological Well-being, Recovery and Sexuality After Total and Subtotal Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Linkoeping'}, 'officialTitle': 'Subtotal Versus Total Abdominal Hysterectomy- a Prospective Randomised Comparison of Medical , Psychological and Sexual Effects.', 'orgStudyIdInfo': {'id': '2009-0102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TH', 'description': 'Total hysterectomy', 'interventionNames': ['Procedure: Total abdominal hysterectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SH', 'description': 'Subtotal hysterectomy', 'interventionNames': ['Procedure: Subtotal abdominal hysterectomy']}], 'interventions': [{'name': 'Total abdominal hysterectomy', 'type': 'PROCEDURE', 'description': 'Total abdominal hysterectomy', 'armGroupLabels': ['TH']}, {'name': 'Subtotal abdominal hysterectomy', 'type': 'PROCEDURE', 'description': 'Subtotal abdominal hysterectomy', 'armGroupLabels': ['SH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57581', 'city': 'Eksjö', 'country': 'Sweden', 'facility': 'Höglandssjukhuset i Eksjö', 'geoPoint': {'lat': 57.66643, 'lon': 14.97205}}, {'zip': '55185', 'city': 'Jönköping', 'country': 'Sweden', 'facility': 'Ryhov Central Hospital', 'geoPoint': {'lat': 57.78145, 'lon': 14.15618}}, {'zip': '39185', 'city': 'Kalmar', 'country': 'Sweden', 'facility': 'County Hospital in Kalmar', 'geoPoint': {'lat': 56.66157, 'lon': 16.36163}}, {'zip': '59185', 'city': 'Motala', 'country': 'Sweden', 'facility': 'Motala Counbty Hospital', 'geoPoint': {'lat': 58.53706, 'lon': 15.03649}}, {'zip': '601 82', 'city': 'Norrköping', 'country': 'Sweden', 'facility': 'Vrinnevi Hospital', 'geoPoint': {'lat': 58.59419, 'lon': 16.1826}}, {'zip': '70146', 'city': 'Örebro', 'country': 'Sweden', 'facility': 'Capio Läkargruppen', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'zip': '33185', 'city': 'Värnamo', 'country': 'Sweden', 'facility': 'Värnamo County Hospital', 'geoPoint': {'lat': 57.18604, 'lon': 14.04001}}], 'overallOfficials': [{'name': 'Preben Kjölhede, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Linköping'}, {'name': 'Pär Persson, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Linköping'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Linkoeping', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Preben Kjolhede', 'investigatorAffiliation': 'University Hospital, Linkoeping'}}}}