Timing of Primary Surgery for Cleft Palate

Timing of Primary Surgery (TOPS) Study Group

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Optimal infant age for primary surgery of isolated cleft palate repair has been debated over decades resulting in considerable variability in international practice. We aimed to compare results of surgery at 6-months with surgery at 12-months of age on speech outcomes, hearing, dentofacial development and safety.

Infants with non-syndromic isolated cleft palate were randomized 1:1 to receive standardized primary surgery for closure of the cleft at 6-months or 12-months of age. Age-appropriate assessments with standardized video and audio recordings at one, three, and five years of age were assessed independently by multiple speech and language therapists blinded to the allocated age at surgery. The primary endpoint was velopharyngeal insufficiency at age five years. Secondary endpoints included speech development, post-operative complications, hearing, dentofacial development and growth.

Across Europe and South America 558 infants (281, 6-months; 277 12-months) were randomized at 23 specialized centers with analyzable speech recordings obtained for 235 (84%), and 226 (82%) children, respectively. Insufficient velopharyngeal function was observed in 21 (9%) and 34 (15%) infants in the 6- and 12-month age groups, respectively (risk ratio 0.59, 95% confidence interval (0.36 to 0.99), p=0.043) at 5 years. Post-operative complications were infrequent and similar between groups. Four serious adverse events were reported (three in 6-month and one in 12-month groups) and had resolved at follow-up.

Medically fit infants with isolated cleft palate repair undertaken in adequately resourced settings at age 6-months had better velopharyngeal function at 5 years than infants repaired at 12-months of age.
(Funded by NIH Grants R21DE15128, U01DE018664 and U01DE018837, www.clinical trials.gov, identifier NCT00993551)

Original languageEnglish
Pages (from-to)795-807
JournalNew England Journal Of Medicine
Issue number9
Publication statusPublished - 31 Aug 2023


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