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A randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a statistical analysis plan
- Source :
- Trials, Vol 22, Iss 1, Pp 1-15 (2021), Trials, TRIALS, Conroy, E J, Cooper, R, Shaw, W, Persson, C, Willadsen, E, Munro, K J, Williamson, P R, Semb, G, Walsh, T & Gamble, C 2021, ' A randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a statistical analysis plan ', Trials, vol. 22, no. 1 . https://doi.org/10.1186/s13063-020-04886-y
- Publication Year :
- 2021
- Publisher :
- Springer Science and Business Media LLC, 2021.
-
Abstract
- Background Cleft palate is among the most common birth abnormalities. The success of primary surgery in the early months of life is crucial for successful feeding, hearing, dental development, and facial growth. Over recent decades, age at palatal surgery in infancy has reduced. The Timing Of Primary Surgery for cleft palate (TOPS) trial aims to determine whether, in infants with cleft palate, it is better to perform primary surgery at age 6 or 12 months (corrected for gestational age). Methods/design The TOPS trial is an international, two-arm, parallel group, randomised controlled trial. The primary outcome is insufficient velopharyngeal function at 5 years of age. Secondary outcomes, measured at 12 months, 3 years, and 5 years of age, include measures of speech development, safety of the procedure, hearing level, middle ear function, dentofacial development, and growth. The analysis approaches for primary and secondary outcomes are described here, as are the descriptive statistics which will be reported. The TOPS protocol has been published previously. Discussion This paper provides details of the planned statistical analyses for the TOPS trial and will reduce the risk of outcome reporting bias and data-driven results. Trial registration ClinicalTrials.gov NCT00993551. Registered on 9 October 2009.
- Subjects :
- Trial design
Statistical analysis plan
medicine.medical_specialty
Middle ear function
Cleft Lip
Medicine (miscellaneous)
Surgical intervention
Update
Unilateral cleft palate
law.invention
Cyclic N-Oxides
03 medical and health sciences
0302 clinical medicine
Primary outcome
Statistical Analysis Plan
Complex intervention
Randomized controlled trial
law
Outcome reporting
medicine
Humans
Pharmacology (medical)
030212 general & internal medicine
Child
Randomised controlled trial
Trial analysis
Palatal surgery
lcsh:R5-920
Velopharyngeal function
Descriptive statistics
business.industry
Infant
Gestational age
030206 dentistry
Surgery
Cleft Palate
Treatment Outcome
Hearing level
Sommerlad technique
lcsh:Medicine (General)
business
Subjects
Details
- ISSN :
- 17456215
- Volume :
- 22
- Database :
- OpenAIRE
- Journal :
- Trials
- Accession number :
- edsair.doi.dedup.....00a7f415084cef0a51beb87f320fefe1