Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT00750035
Status:
COMPLETED
Last Update Posted:
2008-10-24
First Post:
2008-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Total Versus Subtotal Hysterectomy:a Randomised, Prospective Multicentre Study of the Effect on Urinary, Sexual and Bowel Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 279}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2000-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-23', 'studyFirstSubmitDate': '2008-09-09', 'studyFirstSubmitQcDate': '2008-09-09', 'lastUpdatePostDateStruct': {'date': '2008-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Main outcome measure was stress incontinence', 'timeFrame': 'Completed'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'Completed'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Total hysterectomy', 'subtotal hysterectomy', 'urinary function', 'bowel function', 'sexual function', 'Quality of life', 'Psychological function'], 'conditions': ['Hysterectomy']}, 'referencesModule': {'references': [{'pmid': '12397189', 'type': 'BACKGROUND', 'citation': 'Thakar R, Ayers S, Clarkson P, Stanton S, Manyonda I. Outcomes after total versus subtotal abdominal hysterectomy. N Engl J Med. 2002 Oct 24;347(17):1318-25. doi: 10.1056/NEJMoa013336.'}, {'pmid': '15383114', 'type': 'BACKGROUND', 'citation': 'Thakar R, Ayers S, Georgakapolou A, Clarkson P, Stanton S, Manyonda I. Hysterectomy improves quality of life and decreases psychiatric symptoms: a prospective and randomised comparison of total versus subtotal hysterectomy. BJOG. 2004 Oct;111(10):1115-20. doi: 10.1111/j.1471-0528.2004.00242.x.'}, {'pmid': '19037034', 'type': 'DERIVED', 'citation': 'Thakar R, Ayers S, Srivastava R, Manyonda I. Removing the cervix at hysterectomy: an unnecessary intervention? Obstet Gynecol. 2008 Dec;112(6):1262-1269. doi: 10.1097/AOG.0b013e31818f3bf5.'}]}, 'descriptionModule': {'briefSummary': 'Background\n\nIt is uncertain whether subtotal abdominal hysterectomy results in better bladder, bowel, or sexual function than total abdominal hysterectomy.\n\nMethods\n\nThe investigators conducted a randomized, double-blind trial comparing total and subtotal abdominal hysterectomy in 279 women referred for hysterectomy because of benign disease; most of the women were premenopausal. The main outcomes were measures of bladder, bowel, and sexual function at 12 months. The investigators also evaluated postoperative complications.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women having abdominal hysterectomy for benign conditions of the uterus\n\nExclusion Criteria:\n\n* Suspected cancer\n* A body weight that exceeded 100 kg\n* Previous pelvic surgery\n* Known endometriosis\n* Abnormal cervical smears,\n* Symptomatic uterine prolapse\n* Symptomatic urinary incontinence'}, 'identificationModule': {'nctId': 'NCT00750035', 'briefTitle': 'Total Versus Subtotal Hysterectomy:a Randomised, Prospective Multicentre Study of the Effect on Urinary, Sexual and Bowel Function', 'organization': {'class': 'OTHER', 'fullName': "St George's Healthcare NHS Trust"}, 'orgStudyIdInfo': {'id': '95.59.14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'total abdominal hysterectomy and', 'interventionNames': ['Procedure: Total abdominal hysterectomy']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Subtotal hysterectomy', 'interventionNames': ['Procedure: Subtotal abdominal hysterectomy']}], 'interventions': [{'name': 'Total abdominal hysterectomy', 'type': 'PROCEDURE', 'description': 'Total abdominal hysterectomy and Subtotal abdominal hysterectomy', 'armGroupLabels': ['1']}, {'name': 'Subtotal abdominal hysterectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW17 0QT', 'city': 'London', 'country': 'United Kingdom', 'facility': "St George's Healthcare NHS Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St George's Healthcare NHS Trust", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ranee Thakar', 'oldOrganization': "St George's Healthcare NHS Trust"}}}}