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Updated: Nov 23, 2025
Author Spotlight: Development of a Novel Finite Element Analysis Model for Improved Orthognathic Surgical Techniques
Published on: October 20, 2023
A randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a
Elizabeth J Conroy1, Rachael Cooper2, William Shaw3
1Liverpool Clinical Trials Centre, University of Liverpool, a member of Liverpool Health Partners, Institute of Child Health, Alder Hey Children's NHS Foundation Trust, Liverpool, L12 2AP, UK. ejconroy@liverpool.ac.uk.
Insights
The Timing Of Primary Surgery (TOPS) trial investigates optimal timing for cleft palate repair in infants. Early or later surgery impacts speech, hearing, and facial development outcomes.
Area of Science:
- Pediatric Surgery
- Craniofacial Anomalies
- Developmental Pediatrics
Background:
- Cleft palate is a common congenital abnormality requiring timely surgical intervention.
- Early surgical success is vital for infant feeding, hearing, dental, and facial growth.
- Recent trends show a reduction in the age of palatal surgery in infants.
Purpose of the Study:
- To compare primary surgical repair at 6 versus 12 months corrected age for cleft palate.
- To evaluate the impact of surgical timing on velopharyngeal function and other developmental outcomes.
Main Methods:
- International, two-arm, parallel group, randomized controlled trial (TOPS trial).
- Primary outcome: velopharyngeal function at 5 years.
- Secondary outcomes include speech, safety, hearing, middle ear function, dentofacial development, and growth at various ages.
Main Results:
- This abstract details planned statistical analyses for the TOPS trial.
- The study aims to provide data-driven results and minimize outcome reporting bias.
Conclusions:
- The statistical analysis plan for the TOPS trial is herein described.
- This detailed plan enhances the reliability and transparency of study findings.
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.
