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ISRCTN
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ISRCTN85414968
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ClinicalTrials.gov identifier
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Public title
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Early reversal of defunctioning ileostomy
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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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N0077155741
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Study hypothesis
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We hypothesize that early reversal of a defunctioning stoma reduces the cost of stoma care and related complications. We expect the quality of life of those patients whop have early reversal will be better that those patients who have a late reversal. We also expect the total time spent in hospital to be reduced.
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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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Surgery: Ileostomy
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Participants - inclusion criteria
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Patients having defunctioning ileostomy as part of a colorectal procedure, that give informed consent. Patients will be identified through the colorectal meetings, held weekly. Standard treatment will not be affected by involvement in the study. At routine hospital visits the study will be discussed with patients. Those expressing an interest will be given information sheets and contact details.
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Participants - exclusion criteria
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Patients that do not give informed consent.
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Anticipated start date
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31/01/2005
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Anticipated end date
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31/07/2007
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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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60
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Interventions
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Participants will be randomly allocated to either the treatment or control group and to one of the subsets by block randomization. Subjects may withdraw their consent at any time and consequently leave the study. Investigator led withdrawal will occur where there is evidence of non-compliance with protocol requirements.
Even if subjects are withdrawn prematurely from the study survival data on such subjects will be collated throughout the protocol defined follow-up period for that subject. Those that fail to attend follow up clinics will be contacted by telephone. The patient’s normal medications are permitted to continue during the course of the study.
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Primary outcome measure(s)
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Early reversal of defunctioning ileostomy.
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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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Derby Hospitals NHS Foundation Trust (UK) NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Mr
J
Lund
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Address
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Derby Hospitals NHS Foundation Trust
Department of Surgery
University of Nottingham Medical school at Derby
Derby City General Hospital
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City/town
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Derby
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Zip/Postcode
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DE22 3DT
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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. 5548
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Email
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jon.lund@nottingham.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2006 Update - Department of Health
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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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29/09/2006
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Last edited
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31/08/2010
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Date ISRCTN assigned
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29/09/2006
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