Randomised controlled trial (RCT) of Pharyngeal Flap and Sphincter Pharyngoplasty in Cleft Palate
Completed
- Conditions
- Cleft palateSurgery
- Registration Number
- ISRCTN14864864
- Lead Sponsor
- HS R&D Regional Programme Register - Department of Health (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Pre- and post-operative complications <br>2. Length of time for surgery and for hospitalisation <br>3. Endoscopic and speech findings <br>4. Surgical blood loss
- Secondary Outcome Measures
Name Time Method ot provided at time of registration