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ISRCTN
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ISRCTN82683558
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ClinicalTrials.gov identifier
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Public title
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Randomised Controlled Study of Fundoplication or Medical Treatment for Gastro-Oesophageal Reflux in Children
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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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RHC22029
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Study hypothesis
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To measure the effectiveness of fundoplication compared to medical managements in a randomised study of children with severe gastro-oesophageal reflux and thus develop management strategies for the appropriate and cost-effective treatment of children with gastro-oesophageal reflux.
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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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Digestive system diseases: Other digestive system disease
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Participants - inclusion criteria
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Children aged less than 16 years with clinical evidence of gastro-oesophageal reflux. Phase One - 250 to 330. Phase Two - 115 to 125.
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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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01/10/2000
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Anticipated end date
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01/10/2003
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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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455
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Interventions
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Fundoplication vs medical managements
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Primary outcome measure(s)
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Body weight Z scores.
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Secondary outcome measure(s)
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1. Continuing or recurrent gastro-oesophageal reflux
2. Complication rate after fundoplication, ECA on EGG
3. Validated quality of life score for patients and parents
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Sources of funding
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NHS Executive North West (UK)
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Trial website
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Publications
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Contact name
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Dr
David
Lloyd
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Address
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Royal Liverpool Children's Hospital NHS Trust
Professor of Paediatric Surgery
Institute of Child Health, Eaton Road
Eaton Road
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City/town
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Liverpool
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Zip/Postcode
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L12 2AP
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Country
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United Kingdom
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Tel
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+44 (0)151 252 5250
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Fax
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+44 (0)151 252 2024
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Email
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Sponsor
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NHS R&D Regional Programme Register - 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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Fax
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+44 (0)20 7307 2623
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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.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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15/08/2011
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Date ISRCTN assigned
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23/01/2004
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