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ISRCTN
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ISRCTN93016131
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ClinicalTrials.gov identifier
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Public title
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A randomised trial to assess the effectiveness, costs and cost-effectiveness of laparoscopic, vaginal and abdominal hysterectomy
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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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HTA 94/16/03
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Study hypothesis
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The project aims to determine by means of a randomised controlled trial the operative problems, benefits, complications and costs of laparoscopic hysterectomy compared to those associated with both conventional abdominal and vaginal methods of hysterectomy. It will be a multicentre study of 1800 cases collected over an 18 month period by surgeons with differing skill levels from a variety of centres. The study will last for 3 years and will include follow-up assessments at 6 weeks, 3 months, 6 months, and 1 year. The effects of training and experience on outcome will be determined. The objectives of the study are to define the place of laparoscopic hysterectomy in gynaecology and to identify the short-term advantages and disadvantages of this approach for both the patients and the NHS.
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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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South Africa, United Kingdom
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Disease/condition/study domain
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Urological and genital diseases: Other urological and genital disease
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Participants - inclusion criteria
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Not provided at time of registration.
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/09/1996
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Anticipated end date
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28/02/2001
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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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1800
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Interventions
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Please note that, as of 25 January 2008, the end date of this trial was updated from 31 August 1999 to 28 February 2001.
Interventions:
Laparoscopic, vaginal or abdominal hysterectomy
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Primary outcome measure(s)
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Operative problems, benefits, complications and costs
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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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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14711749
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Contact name
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Mr
Raymond
Garry
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Address
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School of Women's and Infants' Health
University of Western Australia
King Edward Memorial Hospital
Subiaco
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City/town
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Perth
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Zip/Postcode
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6008
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Country
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Australia
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Tel
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+61 89340 1331
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Fax
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+61 89381 3031
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Email
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rgarry@obsgyn.uwa.edu.au
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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06/08/2008
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Date ISRCTN assigned
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25/04/2003
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