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ISRCTN
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ISRCTN45833259
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ClinicalTrials.gov identifier
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Public title
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Intra-operative balloon dilatation of the pylorus in oesophagogastrectomy.
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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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N0051127200
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Study hypothesis
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To determine if routine intra-operative balloon dilatation of the pylorus eliminates delayed gastric emptying and may therefore be a feasible alternative to pyloroplasty/pyloromyotomy.
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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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Oesophagogastrectomy
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Participants - inclusion criteria
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Patients undergoing oesophagogastrectomy
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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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01/04/2003
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Anticipated end date
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31/03/2005
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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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Randomised Controlled Trial to determine if routine intra-operative balloon dilatation of the pylorus eliminates delayed gastric emptying and may therefore be a feasible alternative to pyloroplasty/pyloromyotomy.
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Primary outcome measure(s)
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1. Contrast swallow score
2. Symptom score
3. Weight gain
4. Duodenogastric reflux
5. Oesophageal acid reflux
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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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Brighton and Sussex University 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
Donald
Manifold
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Address
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Brighton & Sussex University Hospitals NHS Trust (RSCH)
Royal Sussex County Hospital
Eastern Road
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City/town
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Brighton
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Zip/Postcode
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BN2 5BE
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Country
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United Kingdom
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Tel
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+44 (0)1273 696955
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Email
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donald.manifold@bsuh.nhs.uk
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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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28/01/2010
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Date ISRCTN assigned
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30/09/2004
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