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ISRCTN
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ISRCTN23921450
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial comparing the efficacy, safety and cost-effectiveness of transurethral resection (TURP), laser vaporisation (LVAP), transurethral needle ablation (TUNA) and microwave thermoablation (MTA) of the prostate
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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 94/04/08
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Study hypothesis
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50% of men over 60 years will experience symptoms attributable to benign prostatic enlargement (BNE). The traditional treatment of TURP is efficacious but carries a mortality of 0.5-1% rising to 8% in the over 80s. The overall morbidity is around 80% and has significant implications for quality of life following surgery. The proposed RCT will comprehensively compare the four surgical options TURP, LVAP TUNA and MTA in terms of efficacy, morbidity, cost and overall health gain. The evidence will be used to examine the relative efficiency of each alternative. Clinicians and purchasers of health care need the results of such analyses before deciding whether or not to invest finite resources in newer treatments.
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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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Benign prostatic enlargement (BNE)
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Participants - inclusion criteria
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Men over 60 years
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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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01/06/1996
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Anticipated end date
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31/05/1999
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Status of trial
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Stopped |
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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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Please note that this trial was terminated due to poor recruitment.
A comparison of the 4 surgical options: TURP, LVAP, TUNA and MTA
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Primary outcome measure(s)
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Efficacy, morbidity, cost and overall health gain.
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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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Contact name
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Mr
Chris
Chapple
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Address
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Department of Urology
Central Sheffield University Hospitals NHS Trust
Royal Hallamshire Hospital
Glossop Road
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City/town
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Sheffield
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Zip/Postcode
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S10 2JF
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Country
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United Kingdom
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Tel
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+44 (0)114 2712559/3047
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Fax
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+44 (0)114 279 8318
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Email
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c.r.chapple@shef.ac.uk
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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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Tel
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+44 (0)1132 545 843
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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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14/10/2009
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Date ISRCTN assigned
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25/04/2003
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