Contact information
Type
Scientific
Primary contact
Prof W C Shaw
ORCID ID
Contact details
Cochrane Oral Health Group
MANDEC
University Dental Hospital
Higher Cambridge Street
Manchester
M15 6FH
United Kingdom
+44 (0)161 275 6620
bill.shaw@man.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RHC17021
Study information
Scientific title
Acronym
Study hypothesis
What is the relative effectiveness and morbidity of pharyngeal flap or sphincter pharyngoplasty for correcting velopharyngeal insufficiency
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Cleft palate
Intervention
Not provided at time of registration
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
1. Pre- and post-operative complications
2. Length of time for surgery and for hospitalisation
3. Endoscopic and speech findings
4. Surgical blood loss
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/1995
Overall trial end date
01/08/2000
Reason abandoned
Eligibility
Participant inclusion criteria
50 patients in each group aged between 3 and 21 years with a repaired cleft palate and clinically diagnosed velopharyngeal insufficiency (VPI)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
100
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/08/1995
Recruitment end date
01/08/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cochrane Oral Health Group
Manchester
M15 6FH
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive North West (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16149831
Publication citations
-
Results
Abyholm F, D'Antonio L, Davidson Ward SL, Kjøll L, Saeed M, Shaw W, Sloan G, Whitby D, Worhington H, Wyatt R, , Pharyngeal flap and sphincterplasty for velopharyngeal insufficiency have equal outcome at 1 year postoperatively: results of a randomized trial., Cleft Palate Craniofac. J., 2005, 42, 5, 501-511, doi: 10.1597/03-148.1.