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ISRCTN
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ISRCTN51860966
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ClinicalTrials.gov identifier
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Public title
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Total versus subtotal hysterectomy: a prospective, randomised, multi-centre study of the effects on urinary, sexual and bowel function
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Scientific title
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Acronym
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N/A
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Serial number at source
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REC00076
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Study hypothesis
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To determine whether subtotal abdominal hysterectomy results in better bladder, bowel or sexual function than total abdominal hysterectomy
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Urological and genital diseases: Menstrual disorders
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Participants - inclusion criteria
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Women referred for hysterectomy because of benign disease; most of the women were premenopausal
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Participants - exclusion criteria
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Aged over 60 years, suspected cancer, a body weight that exceeded 100 kg, previous pelvic surgery, known endometriosis, abnormal cervical smears, symptomatic uterine prolapse, symptomatic urinary incontinence
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Anticipated start date
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01/01/1996
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Anticipated end date
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01/01/1999
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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Subtotal hysterectomy vs total hysterectomy
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Primary outcome measure(s)
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Measures of bladder, bowel and sexual function at 12 months
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NHS Executive London
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Trial website
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Publications
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2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12397189
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Contact name
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Dr
Isaac
Manyonda
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Address
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St George's Healthcare NHS Trust
Department of Obstetrics & Gynaecology
St George's Hospital
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City/town
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London
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Zip/Postcode
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SW7 0QT
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Country
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United Kingdom
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Email
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imanyond@sghms.ac.uk
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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18/11/2010
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Date ISRCTN assigned
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23/01/2004
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