Randomised controlled trial (RCT) of Pharyngeal Flap and Sphincter Pharyngoplasty in Cleft Palate
| ISRCTN | ISRCTN14864864 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14864864 |
| Secondary identifying numbers | RHC17021 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 04/10/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof W C Shaw
Scientific
Scientific
Cochrane Oral Health Group
MANDEC, University Dental Hospital
Higher Cambridge Street
Manchester
M15 6FH
United Kingdom
| Phone | +44 (0)161 275 6620 |
|---|---|
| bill.shaw@man.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | What is the relative effectiveness and morbidity of pharyngeal flap or sphincter pharyngoplasty for correcting velopharyngeal insufficiency |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cleft palate |
| Intervention | Not provided at time of registration |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 study start date | 01/08/1995 |
| Completion date | 01/08/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 21 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 50 patients in each group aged between 3 and 21 years with a repaired cleft palate and clinically diagnosed velopharyngeal insufficiency (VPI) |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/1995 |
| Date of final enrolment | 01/08/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cochrane Oral Health Group
Manchester
M15 6FH
United Kingdom
M15 6FH
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive North West (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2005 | Yes | No |
