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ISRCTN
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ISRCTN35624133
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ClinicalTrials.gov identifier
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Public title
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Walk in nasal endoscopy (WINES) study: a pilot evaluation of the safety and feasibility, and cost savings of introducing a radically new approach to upper gastrointestinal (GI) endoscopy
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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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N0077132412
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Study hypothesis
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Evaluation of safety and feasibility of a walk in two week cancer waiting list upper GI endoscopy using nasal endoscope and only one assistant. A single consultant ATC doing the procedures.
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Lay summary
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Not provided at time of registration
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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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Cancer: Gastrointestinal
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Participants - inclusion criteria
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Patients attending for endoscopy through two-week cancer waiting list.
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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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21/10/2003
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Anticipated end date
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01/12/2004
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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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Not provided at time of registration
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Interventions
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Nasal endoscopy is currently performed in the endoscopy unit at Derby City General Hospital but in a procedure analogous to conventional endoscopy using two nurse assistants. The study will be a pilot randomised controlled study comparing conventional with nasal (ultraslim endoscopy) to assess primarily the safety and feasibility of performing nasal endoscopy with just one assistant and the patient in a seated position.
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Primary outcome measure(s)
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Primary endpoints will be the proportion of cases in which this procedure could be performed and the number of early to late (within 1 week) complications. Assessment of safety will be by pro forma records of complications during endoscopy and prior to discharge and by using a patient questionnaire administered 1 week later.
The endoscopist will assess the feasibility of the nasal procedure. Completeness of endoscopy and visualisation of the duodenum, antrum, body and fundus of the stomach and oesophagus will be recorded.
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Secondary outcome measure(s)
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Secondary endpoints will be a questionnaire of the patients acceptability of the procedure and a preliminary assessment of the savings in staff costs of this procedure.
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Sources of funding
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Southern Derbyshire Acute Hospitals NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
A
Cole
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Address
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Southern Derbyshire Acute Hospitals NHS Trust
Derby City General Hospital
Uttoxeter Road
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City/town
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Derby
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Zip/Postcode
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DE22 3NE
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Country
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United Kingdom
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Tel
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+44 (0)1332 340131 Ext 5046
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Email
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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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02/11/2011
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Date ISRCTN assigned
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30/09/2004
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