Improving Outcomes in Cleft Palate Surgery
- Conditions
- Cleft Palate
- Registration Number
- NCT02583100
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- Brief Summary
This is a pilot study to determine if an audit and feedback intervention decreases complication rates after cleft palate surgery.
- Detailed Description
This study will determine whether a surgeon-directed audit and feedback intervention reduces rates of oro-nasal fistula after cleft palate repair. Fistula is an important potential complication of cleft palate repair.
The study also evaluates feasibility of standardized outcome measurement in the care of children with cleft lip and palate, acceptability of standardized measurement, and acceptability of the audit and feedback intervention among surgeons.
The results of this research will improve child health by enabling cleft surgeons to critically evaluate and improve their patient's outcomes.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
Active surgeon performing cleft palate repair in the US or Canada.
none
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Oro-nasal Fistula 12 weeks Presence or absence of fistula of the palate
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Duke Children's Hospital
🇺🇸Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Penn State Hershey Craniofacial Clinic
🇺🇸Hershey, Pennsylvania, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Phoenix Children's Hospital🇺🇸Phoenix, Arizona, United States