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ISRCTN
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ISRCTN49078427
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ClinicalTrials.gov identifier
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Public title
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A prospective randomised controlled trial of traditional hysteroscopy or "no touch" hysteroscopy comparing patient discomfort and time taken to perform each procedure
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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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N0256130918
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Study hypothesis
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To determine whether women who undergo traditional hysteroscopy experience more discomfort during hysteroscopy compared to women who undergo no touch hysteroscopy
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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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Not Applicable: Hysteroscopy
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Participants - inclusion criteria
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120 patients
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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21/10/2003
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Anticipated end date
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31/10/2004
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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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120
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Interventions
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Women were randomised to undergo either traditional saline hysteroscopy requiring the use of a speculum and tenaculum, or a 'no-touch' vaginoscopic hysteroscopy which does not require a speculum or tenaculum. Each group was further subdivided to have hysteroscopy with either a 2.9-mm or 4-mm hysteroscope. Patients were asked to complete pre- and postprocedure questionnaires ranking pain scores.
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Primary outcome measure(s)
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Service outcome development
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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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The Royal Free Hampstead NHS Trust (UK)
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Trial website
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Publications
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2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15958000
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Contact name
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Dr
Adam L
Magos
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Address
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University Department of Obstetrics & Gynaecology
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
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City/town
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London
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Zip/Postcode
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NW3 2QG
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - 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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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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13/07/2009
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Date ISRCTN assigned
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30/09/2004
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