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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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12 February 2013 |
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Main ID: |
ISRCTN14864864 |
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Date of registration:
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23/01/2004 |
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Primary sponsor: |
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Public title:
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Randomised controlled trial (RCT) of Pharyngeal Flap and Sphincter Pharyngoplasty in Cleft Palate
N/A |
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Scientific title:
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Date of first enrolment:
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Aug 1 1995 |
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Target sample size:
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100 |
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Recruitment status: |
Completed/Not recruiting |
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URL:
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http://isrctn.org/ISRCTN14864864 |
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Study type:
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Interventional |
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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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Contacts
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Name:
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W C
Shaw |
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Address:
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Cochrane Oral Health Group
MANDEC, University Dental Hospital
Higher Cambridge Street
M15 6FH
Manchester
United Kingdom |
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Telephone:
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+44 (0)161 275 6620 |
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Email:
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bill.shaw@man.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 50 patients in each group aged between 3 and 21 years with a repaired cleft palate and clinically diagnosed velopharyngeal insufficiency (VPI)
Exclusion criteria: Not provided at time of registration
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Cleft palate
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Intervention(s)
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Not provided at time of registration
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Primary Outcome(s)
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1. Pre- and post-operative complications
2. Length of time for surgery and for hospitalisation
3. Endoscopic and speech findings
4. Surgical blood loss
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Secondary Outcome(s)
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Not provided at time of registration
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Source(s) of Monetary Support
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NHS Executive North West (UK)
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