A randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a statistical analysis plan

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.

Adapting Elements of Cleft Care Protocols in Low- and Middle-income Countries During and After COVID-19: A Process-driven Review With Recommendations

“…Evidence suggests the palate needs to be functional when sounds are first learned in order to avoid the development of compensatory speech patterns ( Chapman et al, 2008 ). The optimal primary palatoplasty regime is a source of continued debate ( Lohmander et al, 2012 ; Rohrich and Byrd, 1990 ) and randomized control trials currently in process aim to define the optimal timing for palatoplasty ( Conroy et al, 2021 ). The SCANDCLEFT trials found that both good and poor functional outcomes can be achieved by a variety of palatoplasty techniques, sequence and timings and concluded that it was probably the operator skill and familiarity with the protocol that was most important ( Shaw and Semb, 2017 ).…”

Adapting cleft care protocols in low- and middle-income countries during and after COVID-19: a process-driven review with recommendations

“…Evidence suggests the palate needs to be functional when sounds are first learned in order to avoid the development of compensatory speech patterns (Chapman et al, 2008). The optimal primary palatoplasty regime is a source of continued debate (Lohmander et al, 2012; Rohrich and Byrd, 1990) and randomised control trials currently in process aim to define the optimal timing for palatoplasty (Conroy et al, 2021). The SCANDCLEFT trials found that both good and poor functional outcomes can be achieved by a variety of palatoplasty techniques, sequence and timings and concluded that it was probably the operator skill and familiarity with the protocol that was most important (Shaw & Semb, 2017).…”

Age at primary surgery among orofacial cleft individuals in Indonesia

“…In Europe and the United States, the recommended age for primary palatal repair is within 12 months. To shed light on the favourable timing of primary surgery for cleft palate, randomized controlled trials are currently underway comparing the outcomes of surgery at 6 months versus 12 months 8,17 . These studies aim to provide valuable insights into the optimal timing for achieving the best results in cleft palate repair.…”